Treatment of Peri-Implant Mucositis With Standard of Care and Bioptron Hyperlight Therapy: A Parallel-Arm Clinical Trial
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-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
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| peri-implant mucositis treated with standard of care-professional mechanical debridement | Active comparator | Device: Photobiomodulation with Bioptron Hyperlight Therapy | patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement |
| peri-implant mucositis treated with photobiomodulation in addition to standard treatment | Experimental | Device: Photobiomodulation with Bioptron Hyperlight Therapy | patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment |
- Photobiomodulation with Bioptron Hyperlight Therapy (Device): 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.
+Outcome measures
Primary outcomes
- Periodontal chart-Probing pocket depth (PPD) [Patients were assessed before study beginning (baseline)]: 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) [Patients were assessed at 6 weeks (T1)]: 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) [Patients were assessed at 12 weeks (T2)]: 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) [Patients were assessed at 24 weeks (T3)]: 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) [Patients were assessed before study beginning (baseline)]: 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) [Patients were assessed at 6 weeks (T1)]: 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) [Patients were assessed at 12 weeks (T2)]: 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) [Patients were assessed at 24 weeks (T3)]: 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) [Patients were assessed before study beginning (baseline)]: 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) [Patients were assessed at 6 weeks (T1)]: 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) [Patients were assessed at 12 weeks (T2)]: 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) [Patients were assessed at 24 weeks (T3)]: 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 outcomes
- Pain relief [Patients were assessed before study beginning (baseline)]: Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
- Pain relief [Patients were assessed at 6 weeks (T1)]: Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
- Pain relief [Patients were assessed at 12 weeks (T2)]: Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
- Pain relief [Patients were assessed at 24 weeks (T3)]: Pain relief assessed with the Numerical Rating Scale-11 (NRS-11)
+Eligibility
Sex: All
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:
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+Locations (1)
| Facility | City | Country | Status |
|---|
| Roberto Felice Grassi | Bari | Italy | |
+Publications
- Results publication: 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. PMID 35565077
+Investigators