Clinical trial NCT05307445: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mucositis Oral
Dental Implant Failed
Keywords: peri-implant mucositis
dental implants
Bioptron
photobiomodulation
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a randomised, double blind clinical trial
Primary purpose: TREATMENT

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


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:

-

Primary outcomes:
measure: Periodontal chart-Probing pocket depth (PPD)
timeFrame: Patients were assessed before study beginning (baseline)
measure: Periodontal chart-Probing pocket depth (PPD)
timeFrame: Patients were assessed at 6 weeks (T1)
measure: Periodontal chart-Probing pocket depth (PPD)
timeFrame: Patients were assessed at 12 weeks (T2)
measure: Periodontal chart-Probing pocket depth (PPD)
timeFrame: Patients were assessed at 24 weeks (T3)
measure: Periodontal chart-Bleeding on probing (BOP)
timeFrame: Patients were assessed before study beginning (baseline)
measure: Periodontal chart-Bleeding on probing (BOP)
timeFrame: Patients were assessed at 6 weeks (T1)
measure: Periodontal chart-Bleeding on probing (BOP)
timeFrame: Patients were assessed at 12 weeks (T2)
measure: Periodontal chart-Bleeding on probing (BOP)
timeFrame: Patients were assessed at 24 weeks (T3)
measure: Periodontal chart- Plaque index (PI)
timeFrame: Patients were assessed before study beginning (baseline)
measure: Periodontal chart- Plaque index (PI)
timeFrame: Patients were assessed at 6 weeks (T1)
measure: Periodontal chart- Plaque index (PI)
timeFrame: Patients were assessed at 12 weeks (T2)
measure: Periodontal chart- Plaque index (PI)
timeFrame: Patients were assessed at 24 weeks (T3)
Secondary outcomes:
measure: Pain relief
timeFrame: Patients were assessed before study beginning (baseline)
measure: Pain relief
timeFrame: Patients were assessed at 6 weeks (T1)
measure: Pain relief
timeFrame: Patients were assessed at 12 weeks (T2)
measure: Pain relief
timeFrame: Patients were assessed at 24 weeks (T3)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Roberto Felice Grassi
Study officials:
affiliation: University of Bari Aldo Moro
name: Roberto F Grassi, Prof
role: STUDY_DIRECTOR
References:
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.