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Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP (RELIEF-OLP)

Primary Purpose

Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Lumoral treatment
Standard oral hygiene self care
Sponsored by
Koite Health Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oral Lichen Planus focused on measuring Lumoral, Lumorinse, Plaque, Oral Lichen Planus, aMMP-8, aPDT, Pain score (VAS)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement
  • Age >18 years
  • Able to provide a written consent
  • Willing and able to complete questionnaires
  • Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol

Exclusion Criteria:

  • Lichenoid lesions suspected to be induced by contact allergy or drugs
  • Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks;
  • Pregnant or lactating
  • Photosensitivity
  • Use of antibiotics within 2 weeks prior the study

Sites / Locations

  • Tampere University Hospital, Oral and maxillofacial diseases
  • Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental careRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.

Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.

Outcomes

Primary Outcome Measures

Pain score symptom diary (based on Visual Analogue Scale - VAS)
Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: '365 Average pain score' (VAS) is determined by calculating the average of the pain scores marked in the diary during the total surveillance period of one year; '52 Average pain score' (VAS) is determined by calculating the average of the pain scores of calendar weeks during the total surveillance period of one year; 'Positive 52 Average pain score' (VAS) is determined by including the '52 Average pain scores' of those calendar weeks, which have VAS average over 2.

Secondary Outcome Measures

aMMP-8
Reduction in inflammation marker aMMP-8 measured by Periosafe®
Visible plaque index (VPI)
Improvement in visible plaque index (VPI)
Bleeding on probing index (BOP)
Improvement in the bleeding on probing index (BOP)
Escudier Index (EI)
Improvement in OLP measured by the Escudier Index (EI)
Visual Analogue Scale - VAS
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Visual Analogue Scale - VAS
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Visual Analogue Scale - VAS
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Oral Lichen Planus (OLP) relapse
Improvement in OLP relapse rate measured by a decreased need for additional/ repeated treatment with corticosteroid treatment, tacrolimus, or other anti-inflammatory treatment
Use of corticosteroid treatment
Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)
Improvement in psychosocial factors assessed by the graded chronic pain scale (GCPS) questionnaire. Grading is based on answering a ten-scale questionnaire from 0, 'no pain' to 10, 'worst possible pain'.
Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)
Improvement in psychosocial factors assessed by the oral health impact profile-14 (OHIP-14) questionnaire. The OHIP-14 is a questionnaire that measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)
Improvement in psychosocial factors assessed by the generalized anxiety disorder (GAD-7) questionnaires. Grading is based on answering a four-scale questionnaire from 0, 'never' to 3, 'almost daily'.
Oral candidosis
Reduction in number of subjects with oral candidosis during the treatment
Desquamative gingivitis clinical score (DGCS)
Improvement in OLP measured by the Desquamative Gingivitis Clinical Score (DGCS) by 20 %. The DGCS is a scoring system specifically designed to score the gingival lesions of oral lichen planus. Scoring: 0 = no detectable lesions present; 1 = white lesion; 2 = mild erythema (< 3 mm from gingival margins); 3 = bulla or marked erythema (> 3 mm from gingival margins); 4 = erosion or ulcer

Full Information

First Posted
May 27, 2022
Last Updated
March 8, 2023
Sponsor
Koite Health Oy
Collaborators
Wellbeing Services County of Pirkanmaa, Tampere University, University of Helsinki, Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05401201
Brief Title
Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP
Acronym
RELIEF-OLP
Official Title
Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Topical Corticosteroid Treatment in Patients With Gingival Involvement of Oral Lichen Planus - a Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koite Health Oy
Collaborators
Wellbeing Services County of Pirkanmaa, Tampere University, University of Helsinki, Tampere University Hospital

4. Oversight

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

5. Study Description

Brief Summary
This study is designed to investigate the effectiveness of plaque control intervention by home-use dual-light aPDT Lumoral -device as an adjunctive or alternative treatment to triamcinolone acetonide (TCA) mouth rinse or other topical corticosteroid treatment on the symptoms and clinical appearance of symptomatic gingival involvement of oral lichen planus (OLP).
Detailed Description
Oral Lichen Planus (OLP) is a relatively common, chronic immune-mediated mucocutaneous disease,that usually occurs on the oral mucosa surfaces. Oral lesions are commonly multiple with a bilateral and symmetrical localization. Most affected sites in the oral cavity are the buccal and lingual mucosa, and the gingiva. Approximately 10% of patients with OLP present manifestations in the gingiva. Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Use of the device can improve supragingival plaque control. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction. A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day. All the subjects shall be assessed for desquamative gingivitis clinical score (DGCS), Escudier Index (EI), visible plaque index (VPI), bleeding on probing index (BOP), pain score (VAS), aMMP-8 inflammation marker and oral candidosis. These analyses shall be performed at baseline and at 4 week, 3, 6 and 12 months after the treatment started. In addition, psychosocial factors shall be assessed by the graded chronic pain scale (GCPS), the oral health impact profile (OHIP-14) and the generalized anxiety disorder (GAD-7) questionnaires at baseline and at 6 and 12 months after the treatment initiation. Primary outcome is improvement in average Pain score (VAS) symptom diary during the 12 month study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus, Dental Plaque, Oral Bacterial Infection
Keywords
Lumoral, Lumorinse, Plaque, Oral Lichen Planus, aMMP-8, aPDT, Pain score (VAS)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A total of 60 subjects with histologically confirmed diagnosis of OLP with gingival involvement are enrolled to the study. The subjects are randomized to a study group and a control group. Both groups will use topical corticosteroid treatment for two weeks. In addition, the study group will use Lumoral-device initially once a day.
Masking
None (Open Label)
Masking Description
A sealed envelope system shall be used for randomization.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Subjects in the study group will use the Lumoral device five to seven times a week according to the verbal and written instructions provided to them. In addition, they will brush their teeth twice daily in their customary manner while using the provided sonic toothbrush and regular toothpaste.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects in the control group will brush their teeth in their customary manner twice daily while using the provided sonic toothbrush and regular toothpaste. They will not receive any additional intervention.
Intervention Type
Device
Intervention Name(s)
Lumoral treatment
Other Intervention Name(s)
Lumorinse mouth rinse
Intervention Description
The investigational Lumoral treatment -device provides a constant and repeatable application which can be done at home and is easily available. All subjects in the study group will receive their own Lumoral treatment -device and Lumorinse-mouth rinse tablets for the complete duration of the study.
Intervention Type
Other
Intervention Name(s)
Standard oral hygiene self care
Other Intervention Name(s)
Sonic toothbrush provided
Intervention Description
Both groups shall be given oral and written instructions for twice-daily standard oral hygiene self care.
Primary Outcome Measure Information:
Title
Pain score symptom diary (based on Visual Analogue Scale - VAS)
Description
Improvement in average Pain score (VAS) symptom diary during the 12 month study period. Assessments: '365 Average pain score' (VAS) is determined by calculating the average of the pain scores marked in the diary during the total surveillance period of one year; '52 Average pain score' (VAS) is determined by calculating the average of the pain scores of calendar weeks during the total surveillance period of one year; 'Positive 52 Average pain score' (VAS) is determined by including the '52 Average pain scores' of those calendar weeks, which have VAS average over 2.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
aMMP-8
Description
Reduction in inflammation marker aMMP-8 measured by Periosafe®
Time Frame
12 Months
Title
Visible plaque index (VPI)
Description
Improvement in visible plaque index (VPI)
Time Frame
12 Months
Title
Bleeding on probing index (BOP)
Description
Improvement in the bleeding on probing index (BOP)
Time Frame
12 Months
Title
Escudier Index (EI)
Description
Improvement in OLP measured by the Escudier Index (EI)
Time Frame
12 Months
Title
Visual Analogue Scale - VAS
Description
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Time Frame
12 Months
Title
Visual Analogue Scale - VAS
Description
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Time Frame
6 Months
Title
Visual Analogue Scale - VAS
Description
Improvement in pain score (Visual Analogue Scale - VAS). Subjects will be asked to rate their pain using a visual analog scale (VAS) from 0-10: 0 = 'no symptoms'; 10 = 'very severe pain'. The amount of improvement in experienced pain is calculated by the following formula: N = [100% × (pre-treatment VAS score-post treatment VAS score)]/pre-treatment VAS score. This result is classified as follows: score 5 = lack of pain or discomfort N=100%; score 4 = marked improvement 75%≤N<100%; scores 3 and 2 = moderate improvement 25%≤N<75%; score 1 = mild improvement 0%<N<25%; score 0 = no improvement N=0. The VAS will be monitored both as a daily home-use diary and as a single question at the clinic during the follow-up visits.
Time Frame
3 Months
Title
Oral Lichen Planus (OLP) relapse
Description
Improvement in OLP relapse rate measured by a decreased need for additional/ repeated treatment with corticosteroid treatment, tacrolimus, or other anti-inflammatory treatment
Time Frame
12 Months
Title
Use of corticosteroid treatment
Description
Reduction in the use of corticosteroid treatment according to the anti-inflammatory potency
Time Frame
6 Months
Title
Graded chronic pain scale (GCPS) questionnaire (authors: Von Korff M et al. 1992)
Description
Improvement in psychosocial factors assessed by the graded chronic pain scale (GCPS) questionnaire. Grading is based on answering a ten-scale questionnaire from 0, 'no pain' to 10, 'worst possible pain'.
Time Frame
12 Months
Title
Oral Health Impact Profile (OHIP-14) questionnaire (author: Slade 1997)
Description
Improvement in psychosocial factors assessed by the oral health impact profile-14 (OHIP-14) questionnaire. The OHIP-14 is a questionnaire that measures people's perception of the social impact of oral disorders on their well-being. Fourteen items of OHIP are divided into seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicaps. Grading is based on answering a five-scale questionnaire from 'Never' to 'Very often'.
Time Frame
12 Months
Title
Generalized anxiety disorder (GAD-7) questionnaire (authors: Spitzer RL et al. 2006)
Description
Improvement in psychosocial factors assessed by the generalized anxiety disorder (GAD-7) questionnaires. Grading is based on answering a four-scale questionnaire from 0, 'never' to 3, 'almost daily'.
Time Frame
12 Months
Title
Oral candidosis
Description
Reduction in number of subjects with oral candidosis during the treatment
Time Frame
12 Months
Title
Desquamative gingivitis clinical score (DGCS)
Description
Improvement in OLP measured by the Desquamative Gingivitis Clinical Score (DGCS) by 20 %. The DGCS is a scoring system specifically designed to score the gingival lesions of oral lichen planus. Scoring: 0 = no detectable lesions present; 1 = white lesion; 2 = mild erythema (< 3 mm from gingival margins); 3 = bulla or marked erythema (> 3 mm from gingival margins); 4 = erosion or ulcer
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of OLP with bilateral symmetrical lesions and gingival involvement Able to provide a written consent Willing and able to complete questionnaires Able to co-operate with the treatment protocol and avoid any other oral hygiene measures outside of the study protocol Exclusion Criteria: Lichenoid lesions suspected to be induced by contact allergy or drugs Any treatment for OLP in two weeks prior to the study/ a history of topical therapy for OLP in the past 2 weeks or systemic therapy in the past 4 weeks; Pregnant or lactating Photosensitivity Use of antibiotics within 2 weeks prior the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tommi Pätilä, Docent
Organizational Affiliation
Chief Medical Officer
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital, Oral and maxillofacial diseases
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
First Name & Middle Initial & Last Name & Degree
Anna Maria Heikkinen, Professor
First Name & Middle Initial & Last Name & Degree
Kati Ylä-Tuuhonen, DDS
Facility Name
Wellbeing services County Pirkanmaa, Health Services, Orthodontics and specialized dental care
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Kylmänen
Phone
+358407245934
Email
mikko.kylmanen@koitehealth.com
First Name & Middle Initial & Last Name & Degree
Anna Maria Heikkinen, Professor
First Name & Middle Initial & Last Name & Degree
Kati Ylä-Tuuhonen, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The IPD will only be administered by the researchers that are listed in the CIP.
Links:
URL
https://link.springer.com/article/10.1007/s41547-019-00056-9
Description
Alaijah, F., Morsi, A., Nasher, R. et al. Photobiomodulation therapy in the treatment of periodontal disease: a literature review
URL
https://pubmed.ncbi.nlm.nih.gov/17261375/
Description
Al-Hashimi I, Schifter M, Lockhart PB, et al., (2007) Oral lichen planus and oral lichenoid lesions: diagnostic and therapeutic considerations
URL
https://pubmed.ncbi.nlm.nih.gov/29223131/
Description
Akram Z, Javed F, Hosein M, et al., (2018) Photodynamic therapy in the treatment of symptomatic oral lichen planus: A systematic review.
URL
https://pubmed.ncbi.nlm.nih.gov/27639053/
Description
Arduino PG, Broccoletti R, Sciannameo V, Scully C. (2017) A practical clinical recording system for cases of desquamative gingivitis
URL
https://pubmed.ncbi.nlm.nih.gov/27401683/
Description
Cheng YS, Gould A, Kurago Z, Fantasia J, Muller S. (2016) Diagnosis of oral lichen planus: a position paper of the American Academy of Oral and Maxillofacial Pathology
URL
https://pubmed.ncbi.nlm.nih.gov/17711534/
Description
Escudier M, Ahmed N, Shirlaw P, et al., (2007) A scoring system for mucosal disease severity with special reference to oral lichen planus.
URL
https://www.hindawi.com/journals/tswj/2014/742826/
Description
Gorouhi F, Davari P, Fazel N (2014) Cutaneous and mucosal lichen planus: a comprehensive review of clinical subtypes, risk factors, diagnosis, and prognosis
URL
https://bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-020-01260-x
Description
He Y, Deng J, Zhao Y, Tao H et al., (2020) Efficacy evaluation of photodynamic therapy for oral lichen planus: a systematic review and meta-analysis.
URL
http://www.fda.gov/media/75892/download
Description
Levine JI. Medications that increase photosensititivity.
URL
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232775
Description
Nikinmaa S, Alapulli H, Auvinen P, et al. (2020) Dual-light photodynamic therapy administered daily provides a sustained antibacterial effect on biofilm and prevents Streptococcus mutans adaptation.
URL
https://pubmed.ncbi.nlm.nih.gov/34063662/
Description
Nikinmaa S, Moilanen N, Sorsa T, et al. (2021a). Indocyanine Green-Assisted and LED-Light-Activated Antibacterial Photodynamic Therapy Reduces Dental Plaque.
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533018/
Description
Nikinmaa S, Podonyi A, Raivio P, et al. (2021b). Daily Administered Dual-Light Photodynamic Therapy Provides a Sustained Antibacterial Effect on Staphylococcus aureus
URL
https://pubmed.ncbi.nlm.nih.gov/15897856/
Description
Piboonniyom SO, Treister N, Pitiphat W, Woo SB. (2005) Scoring system for monitoring oral lichenoid lesions: a preliminary study.
URL
https://pubmed.ncbi.nlm.nih.gov/9332805/
Description
Slade GD (1997) Derivation and validation of a short-form oral health impact profile
URL
https://pubmed.ncbi.nlm.nih.gov/16717171/
Description
Spitzer RL, Kroenke K, Williams JBW, Löwe B (2006) A brief measure for assessing generalized anxiety disorder: the GAD-7
URL
https://pubmed.ncbi.nlm.nih.gov/1408309/
Description
Von Korff M, Ormel J, Keefe FJ, Dworkin SF (1992) Grading the severity of chronic pain
URL
https://www.nice.org.uk/guidance/ipg615
Description
NICE Guidance IPG615. Low-level laser therapy for preventing or treating oral mucositis caused by radiotherapy or chemotherapy. Interventional procedures guidance [IPG615]. Published: 23 May 2018.

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Dual-light Antibacterial Photodynamic Therapy as an Adjunctive Treatment to Corticosteroid Treatment in OLP

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