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Photobiomodulation in Oral Lichen Planus

Primary Purpose

Lichen Planus, Oral, Low-Level Light Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Propionate clobetasol gel 0.05%
Photobiomodulation
Placebo gel
Placebo Photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Planus, Oral focused on measuring oral lichen planus; photobiomodulation; inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO).

Exclusion Criteria:

  • Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.

Sites / Locations

  • Scholl of Dentistry, University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Photobiomodulation

Propionate clobetasol gel 0.05%

Arm Description

Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ =660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.

Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.

Outcomes

Primary Outcome Measures

Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Assessment of Pain of OLP
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.

Secondary Outcome Measures

Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Assessment of clinical presentation of OLP
Clinical data will be evaluated by scores according to Thongprasom et al
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Function
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Clinical Resolution
The clinical resolution will be evaluated at the end of treatment (day 30) according to Corozzo et al. (1999). Complete resolution will be considered when patients present absence of symptoms and remission of atrophic/erosive lesions regardless the presence of any persisting hyperkeratotic lesions. Partial resolution will be considered when a decrease but not the complete remission of atrophic/erosive areas and symptoms were observed. No response to treatment will be considered when OLP lesions present the same clinical or worse presentation in relation to the baseline condition.
Recurrence rate
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Recurrence rate
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Assessment of Quality of life in OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Assessment of Quality of lifein OLP patients
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
October 17, 2017
Last Updated
December 21, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03320460
Brief Title
Photobiomodulation in Oral Lichen Planus
Official Title
Efficacy of Photobiomodulation for Oral Lichen Planus Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study was to compare the efficacy of PBM (660nm) and corticosteroid therapy with clobetasol propionate 0.05% in the treatment of OLP. This is a protocol for a randomized, controlled, double blind clinical trial. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% for 30 consecutive days and with placebo PBM twice a week. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive PBM twice a week during 1 month (laser λ = 660±10 nm; power 100mW; radiant energy 177J/cm2; 5-s exposure time per point and 0.5J of energy per point. The primary variable (pain) and the secondary variables including clinical scores and functional scores as well as patient anxiety and depression (The Hospital Anxiety and Depression Scale-HADS), will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).
Detailed Description
Oral lichen planus is an idiopathic chronic mucocutaneous disease with a ride range of clinical manifestations, including white reticular patches, erosive/ulcerative and atrophic lesions, both associated with intense symptomatology. CD4+ and CD8+ T lymphocytes cells play an important role in the pathogenesis of OLP and are responsible for the production of different cytokines, including IL-6, IL-10, IL-1β, INF-γ and TNF-α. Treatment is symptomatic and topical corticosteroids are commonly used as standard therapy. However, patients frequently present relapses after treatment's discontinuation, develop resistance to corticosteroids therapy as well as secondary candidiasis. Photobiomodulation (PBM) has shown to be a potential therapeutic tool to treat inflammatory disorders, including OLP. Some studies have demonstrated that PBM improves the clinical presentation of OLP (erosive/ulcerative or atrophic lesions to reticular lesions), reduces pain and recurrence. However, it remains controversy if PBM is more effective than corticosteroid in the treatment of OLP. The aim of this study is to evaluate the efficacy of PBM in the treatment of OLP in relation to the standard therapy with corticosteroids. This is a protocol for a randomized, controlled, doubled blind clinical trial, with two months of follow up. Patients with symptomatic OLP and with histopathological diagnosis of OLP based on WHO criteria will be included in this study. Fourty-four patients will be randomized in two experimental groups. Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM (laser λ = 660±10 nm; power 100mW; radiant energy; 177J/cm2; 5-s exposure time per point and 0.5J of energy per point). The primary variable (pain by VAS scale) and the secondary variables (clinical scores, functional scores and Patient anxiety and depression) will be evaluated at the baseline, once a week during treatment and after 30 and 60 days of follow up. Evaluation of clinical resolution will be performed at the end of the treatment (30 days). Evaluation of recurrence will be performed after 30 and 60 days of follow up. Serum and salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated at baseline and at the end of treatment (30 days). Quality of life will be evaluated by OHIP-14 questionnaire at baseline, at the end of treatment and after 30 and 60 days of follow up. The findings will be computed and submitted to statistical analysis. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. If necessary, transformation methods or non-parametric tests will be applied. The chi-square test, Student's t-test and ANOVA will be used and the level of significance of 5% will be considered (p < 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral, Low-Level Light Therapy
Keywords
oral lichen planus; photobiomodulation; inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group Experimental Group
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Control group will be treated with clobetasol propionate 0.05% gel for 30 consecutive days and the laser device will be positioned over the lesion but will be switched off to mask the treatment. The experimental group will be treated with placebo gel for 30 consecutive days to mask the treatment and patients will receive laser treatment twice a week during 1 month for PBM
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Description
Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ =660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.
Arm Title
Propionate clobetasol gel 0.05%
Arm Type
Active Comparator
Arm Description
Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days. Laser device will be positioned over the lesion but will be switched off to mask the treatment. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Propionate clobetasol gel 0.05%
Other Intervention Name(s)
Clobetasol
Intervention Description
Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days and with placebo laser twice a week. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation
Other Intervention Name(s)
Low level laser therapy
Intervention Description
Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ = 660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.
Intervention Type
Other
Intervention Name(s)
Placebo gel
Other Intervention Name(s)
inative gel
Intervention Description
Placebo gel for 30 consecutive days to mask the treatment
Intervention Type
Other
Intervention Name(s)
Placebo Photobiomodulation
Other Intervention Name(s)
Laser off
Intervention Description
Laser device will be positioned over the lesion but will be switched off to mask the treatment.
Primary Outcome Measure Information:
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
Participants will be evaluated at baseline (Day 0)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
Participants will be evaluated after 1 week of treatment (Day 7)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
Participants will be evaluated after 2 weeks of treatment (Day 14)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
Participants will be evaluated after 3 weeks of treatment (Day 21)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
Participants will be evaluated after 4 weeks of treatment (Day 30)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
30 days after the discontinuation of treatment (follow-up period)
Title
Assessment of Pain of OLP
Description
The pain will be assessed by applying a Visual Analog Scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line according to the best value that matches the intensity of pain during the evaluation.
Time Frame
60 days after the discontinuation of treatment (follow-up period)
Secondary Outcome Measure Information:
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
Participants will be evaluated at baseline (Day 0)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
Participants will be evaluated after 1 week of treatment (Day 7)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
Participants will be evaluated after 2 weeks of treatment (Day 14)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated scores according to Thongprasom et al
Time Frame
Participants will be evaluated after 3 weeks of treatment (Day 21)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
Participants will be evaluated after 4 weeks of treatment (Day 30)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
30 days after the discontinuation of treatment (follow-up period)
Title
Assessment of clinical presentation of OLP
Description
Clinical data will be evaluated by scores according to Thongprasom et al
Time Frame
60 days after the discontinuation of treatment (follow-up period)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
Participants will be evaluated at baseline (Day 0)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
Participants will be evaluated after 1 week of treatment (Day 7)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
Participants will be evaluated after 2 weeks of treatment (Day 14)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
Participants will be evaluated after 3 weeks of treatment (Day 21)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
Participants will be evaluated after 4 weeks of treatment (Day 30)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
30 days after the discontinuation of treatment (follow-up period)
Title
Function
Description
The functional scores will be applied to evaluate chewing function, swallowing, fluid intake and altered sense of taste, according to Libelly et al (2006). Each function evaluated will receive the follow scores: 0 ( no difficulty) , 1 ( mild difficulty) , 2, ( moderate difficulty), 3, (severe difficulty), and 4 ( impossibility to perform certain function).
Time Frame
60 days after the discontinuation of treatment (follow-up period)
Title
Clinical Resolution
Description
The clinical resolution will be evaluated at the end of treatment (day 30) according to Corozzo et al. (1999). Complete resolution will be considered when patients present absence of symptoms and remission of atrophic/erosive lesions regardless the presence of any persisting hyperkeratotic lesions. Partial resolution will be considered when a decrease but not the complete remission of atrophic/erosive areas and symptoms were observed. No response to treatment will be considered when OLP lesions present the same clinical or worse presentation in relation to the baseline condition.
Time Frame
Participants will be evaluated after 4 weeks of treatment (Day 30)
Title
Recurrence rate
Description
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Time Frame
The recurrence rate will be evaluated 30 days after the discontinuation of treatment (follow-up period)
Title
Recurrence rate
Description
No recurrence will be considered when the patient presents the same clinical aspect of lesion at the end of treatment and recurrence, when the patient present new atrophic/erosive lesion at the same site during the follow-up period.
Time Frame
The recurrence rate will be evaluated 60 days after the discontinuation of treatment (follow-up period)
Title
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Description
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Time Frame
Baseline (day 0)
Title
Salivary levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Description
The samples will be centrifuged and stored at -80°C. Salivary levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Time Frame
After 4 weeks of treatment (Day 30)
Title
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Description
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Time Frame
Baseline (Day 0)
Title
Serum levels of IL-1β, IL-6, IL-8, IL-10 and TNFα
Description
Peripheral blood will be centrifuged at 400xg for 10 min at 4°C. Serum will be collected and stored at -80°C. Serum levels of IL-6, IL-10, IL-1β, INF-γ and TNF-α will be evaluated by Enzyme Linked Immune Sorbent Assay (ELISA), according to manufacturer's instructions.
Time Frame
After 4 weeks of treatment (Day 30)
Title
Assessment of Quality of life in OLP patients
Description
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Time Frame
Baseline (Day 0)
Title
Assessment of Quality of life in OLP patients
Description
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Time Frame
After 4 weeks of treatment (Day 30)
Title
Assessment of Quality of life in OLP patients
Description
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Time Frame
30 days after the discontinuation of treatment (follow-up period)
Title
Assessment of Quality of lifein OLP patients
Description
Patient quality of life will be measured by means of the Oral Health Impact Profile (OHIP 14)
Time Frame
60 days after the discontinuation of treatment (follow-up period)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
Baseline (Day 0)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
Participants will be evaluated after 1 week of treatment (Day 7)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
Participants will be evaluated after 2 weeks of treatment (Day 14)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
Participants will be evaluated after 3 weeks of treatment (Day 21)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
Participants will be evaluated after 4 weeks of treatment (Day 30)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
30 days after the discontinuation of treatment (follow-up period)
Title
Anxiety and Depression
Description
Patient anxiety and depression will be measured by means of The Hospital Anxiety and Depression Scale (HADS)
Time Frame
60 days after the discontinuation of treatment (follow-up period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participants in this study will be male and female (aged over 18 years) diagnosed with symptomatic oral lichen planus, based on the clinical and histopathological criteria of the World Health Organization (WHO). Exclusion Criteria: Patients with ongoing cancer; pregnant or breastfeeding women; patients with history of corticosteroids and nonsteroidal anti-inflammatory treatment in the last one months, patients with uncontrolled systemic disease; consumption of illicit drugs; use of medication associated with oral lichenoid reactions; amalgam restoration near to OLP lesions; epithelial dysplasia in the histopathological examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Paula C Silva, Bachelor
Phone
+ 55 11 3385-9197
Email
aninha@uninove.br
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Carolina RT Horliana, PhD
Phone
+55 13 981999848
Email
annacrth@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Fernanda SD Rodrigues, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scholl of Dentistry, University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camilla Barros Gallo, PhD
Phone
1130917883
Email
fernandarodrigues@uni9.pro.br
First Name & Middle Initial & Last Name & Degree
Maria F Rodrigues, PhD
First Name & Middle Initial & Last Name & Degree
Camila B Gallo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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28766756
Citation
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Photobiomodulation in Oral Lichen Planus

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