Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy
Primary Purpose
Mucositis Oral, Dental Implant Failed
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Photobiomodulation with Bioptron Hyperlight Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mucositis Oral focused on measuring peri-implant mucositis, dental implants, Bioptron, photobiomodulation
Eligibility Criteria
Inclusion Criteria:
- Male or female, 30-60 years old.
- With diagnosis of peri-implant mucositis.
- Plaque index (PI) ≥ 40%.
- Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
- No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
- No pharmacological therapies, no chemo-radiotherapies.
- No smoking (>10 cigarettes/day), alcohol and/or drug consumption.
- No pregnancy or breastfeeding.
- No allergy.
Exclusion Criteria:
-
Sites / Locations
- Roberto Felice Grassi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
peri-implant mucositis treated with standard of care-professional mechanical debridement
peri-implant mucositis treated with photobiomodulation in addition to standard treatment
Arm Description
patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement
patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment
Outcomes
Primary Outcome Measures
Periodontal chart-Probing pocket depth (PPD)
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Periodontal chart-Probing pocket depth (PPD)
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Periodontal chart-Probing pocket depth (PPD)
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Periodontal chart-Probing pocket depth (PPD)
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Periodontal chart-Bleeding on probing (BOP)
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Periodontal chart-Bleeding on probing (BOP)
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Periodontal chart-Bleeding on probing (BOP)
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Periodontal chart-Bleeding on probing (BOP)
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Periodontal chart- Plaque index (PI)
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Periodontal chart- Plaque index (PI)
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Periodontal chart- Plaque index (PI)
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Periodontal chart- Plaque index (PI)
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Secondary Outcome Measures
Pain relief
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Pain relief
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Pain relief
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Pain relief
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Full Information
NCT ID
NCT05307445
First Posted
March 22, 2022
Last Updated
March 31, 2022
Sponsor
University of Roma La Sapienza
1. Study Identification
Unique Protocol Identification Number
NCT05307445
Brief Title
Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy
Official Title
Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
January 10, 2021 (Actual)
Study Completion Date
January 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza
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
Objectives:
The aim of this study was to evaluate in a cohort of patients with peri-implant mucositis: (a) the efficacy of professional mechanical debridement therapy assisted using Bioptron Hyperlight Therapy on the reduction of periodontal indexes (b) the reduction of total oxidative salivary stress.
Material and Methods Forty subjects with a diagnosis of peri-implant mucositis were enrolled in this study and randomly assigned to the study group (mechanical debridement therapy assisted using Bioptron Hyperlight Therapy) or control group (mechanical debridement therapy alone). The study duration was 6 months. Data on plaque index (PI), bleeding on probing (BoP), probing pocket depth (PPD) and pain relief on Visual Analogue Scale (VAS) were recorded at T0, T1 (14 days), T2 (1 month) and T3 (6 months). Group differences were assessed using Student's t-test and Pearson's Chi-squared test of homogeneity
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral, Dental Implant Failed
Keywords
peri-implant mucositis, dental implants, Bioptron, photobiomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a randomised, double blind clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
peri-implant mucositis treated with standard of care-professional mechanical debridement
Arm Type
Active Comparator
Arm Description
patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement
Arm Title
peri-implant mucositis treated with photobiomodulation in addition to standard treatment
Arm Type
Experimental
Arm Description
patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment
Intervention Type
Device
Intervention Name(s)
Photobiomodulation with Bioptron Hyperlight Therapy
Intervention Description
The Bioptron® Device provides polarized visible polychromatic noncoherent light with 90 W; light wavelength = 480-3400 nm; degree of polarization = 95%; specific power = 40 mW/cm2; energy density = 2.4 J/cm2. The duration of each treatment session was 10 min. Bioptron light was positioned 10 cm from the oral mucosa and a mouth opener was positioned for the entire duration of the session. Two weekly sessions during the first 4 weeks of treatment were applied.
Primary Outcome Measure Information:
Title
Periodontal chart-Probing pocket depth (PPD)
Description
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Time Frame
Patients were assessed before study beginning (baseline)
Title
Periodontal chart-Probing pocket depth (PPD)
Description
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Time Frame
Patients were assessed at 6 weeks (T1)
Title
Periodontal chart-Probing pocket depth (PPD)
Description
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Time Frame
Patients were assessed at 12 weeks (T2)
Title
Periodontal chart-Probing pocket depth (PPD)
Description
Probing pocket depth (PPD). PPD is a periodontal index. It is used to measure the depth of the tissue surrounding the dental implant; with notches measured in millimeters. The probe is placed in between the dental implant and gums and measures the depth of what is called the periodontal pocket- the space between the dental implant and the surrounding gums and bone.
Time Frame
Patients were assessed at 24 weeks (T3)
Title
Periodontal chart-Bleeding on probing (BOP)
Description
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Time Frame
Patients were assessed before study beginning (baseline)
Title
Periodontal chart-Bleeding on probing (BOP)
Description
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Time Frame
Patients were assessed at 6 weeks (T1)
Title
Periodontal chart-Bleeding on probing (BOP)
Description
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Time Frame
Patients were assessed at 12 weeks (T2)
Title
Periodontal chart-Bleeding on probing (BOP)
Description
Bleeding on probing (BOP). Bleeding on probing (BOP) is a parameter to measure soft tissue inflammation. It is measured with the use of a dental probe. The grading is :
0: normal colour of gingiva, no inflammation, no bleeding;
1: slight inflammation; no bleeding;
2: moderate inflammation; presence of bleeding on probing;
3: severe inflammation; tendency to spontaneus bleeding.
Time Frame
Patients were assessed at 24 weeks (T3)
Title
Periodontal chart- Plaque index (PI)
Description
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Time Frame
Patients were assessed before study beginning (baseline)
Title
Periodontal chart- Plaque index (PI)
Description
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Time Frame
Patients were assessed at 6 weeks (T1)
Title
Periodontal chart- Plaque index (PI)
Description
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Time Frame
Patients were assessed at 12 weeks (T2)
Title
Periodontal chart- Plaque index (PI)
Description
Plaque index (PI). Plaque index is used to evaluate the level and rate of plaque formation on dental implant surfaces. The grading is :
0: no visible plaque;
1: thin plaque layer detectable by scraping;
2: moderate plaque layer; visible to the naked eye;
3: abundant plaque layer.
Time Frame
Patients were assessed at 24 weeks (T3)
Secondary Outcome Measure Information:
Title
Pain relief
Description
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame
Patients were assessed before study beginning (baseline)
Title
Pain relief
Description
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame
Patients were assessed at 6 weeks (T1)
Title
Pain relief
Description
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame
Patients were assessed at 12 weeks (T2)
Title
Pain relief
Description
Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
Time Frame
Patients were assessed at 24 weeks (T3)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 30-60 years old.
With diagnosis of peri-implant mucositis.
Plaque index (PI) ≥ 40%.
Al least one implant site with PPD≥4 mm, BOP+ and suppuration.
No uncontrolled diabetes, cardiovascular diseases, bone metabolism disorders, no autoimmune diseases (lichen planus, pemphigoid, pemphigus and systemic lupus erythematosus).
No pharmacological therapies, no chemo-radiotherapies.
No smoking (>10 cigarettes/day), alcohol and/or drug consumption.
No pregnancy or breastfeeding.
No allergy.
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto F Grassi, Prof
Organizational Affiliation
University of Bari Aldo Moro
Official's Role
Study Director
Facility Information:
Facility Name
Roberto Felice Grassi
City
Bari
ZIP/Postal Code
70121
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35565077
Citation
Nardi GM, Mazur M, Papa G, Petruzzi M, Grassi FR, Grassi R. Treatment of Peri-Implant Mucositis with Standard of Care and Bioptron Hyperlight Therapy: A Randomized Clinical Trial. Int J Environ Res Public Health. 2022 May 7;19(9):5682. doi: 10.3390/ijerph19095682.
Results Reference
derived
Learn more about this trial
Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy
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