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

University of Roma La Sapienza

Status: Completed

Conditions: Mucositis Oral; Dental Implant Failed

Treatments: Device: Photobiomodulation with Bioptron Hyperlight Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05307445

3464/23.12.2016

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

peri-implant mucositis treated with standard of care-professional mechanical debridement

Active Comparator group

Description:

patients with peri-implant mucositis are treated with standard of care, i.e. professional mechanical debridement

Treatment:

Device: Photobiomodulation with Bioptron Hyperlight Therapy

peri-implant mucositis treated with photobiomodulation in addition to standard treatment

Experimental group

Description:

patients with peri-implant mucositis are treated with photobiomodulation in addition to standard treatment

Treatment:

Device: Photobiomodulation with Bioptron Hyperlight Therapy