Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy

Study Overview
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Brief Summary
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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

Official Title
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Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial

Conditions
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Mucositis Oral, Dental Implant Failed

Intervention / Treatment
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* Device: Photobiomodulation with Bioptron Hyperlight Therapy


Participation Criteria
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Eligibility Criteria
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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: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomised, double blind clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: peri-implant mucositis treated with standard of care-professional mechanical debridement<br>patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement | Device: Photobiomodulation with Bioptron Hyperlight Therapy<br>* 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.<br>|
| Experimental: peri-implant mucositis treated with photobiomodulation in addition to standard treatment<br>patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment | Device: Photobiomodulation with Bioptron Hyperlight Therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Patients were assessed before study beginning (baseline) | 
| 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. | Patients were assessed at 6 weeks (T1) | 
| 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. | Patients were assessed at 12 weeks (T2) | 
| 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. | Patients were assessed at 24 weeks (T3) | 
| 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. | Patients were assessed before study beginning (baseline) | 
| 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. | Patients were assessed at 6 weeks (T1) | 
| 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. | Patients were assessed at 12 weeks (T2) | 
| 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. | Patients were assessed at 24 weeks (T3) | 
| 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. | Patients were assessed before study beginning (baseline) | 
| 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. | Patients were assessed at 6 weeks (T1) | 
| 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. | Patients were assessed at 12 weeks (T2) | 
| 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. | Patients were assessed at 24 weeks (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief | Pain relief assessed with the Numerical Rating Scale-11 (NRS-11) | Patients were assessed before study beginning (baseline) | 
| Pain relief | Pain relief assessed with the Numerical Rating Scale-11 (NRS-11) | Patients were assessed at 6 weeks (T1) | 
| Pain relief | Pain relief assessed with the Numerical Rating Scale-11 (NRS-11) | Patients were assessed at 12 weeks (T2) | 
| Pain relief | Pain relief assessed with the Numerical Rating Scale-11 (NRS-11) | Patients were assessed at 24 weeks (T3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peri-implant mucositis, dental implants, Bioptron, photobiomodulation