NCT05711576

Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis

The Effect of Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis. A Randomized Placebo-controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: University of Catania · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI and full-mouth disinfection (FMD) with respect to NSPI and placebo in the treatment of PM at 6 months follow-up. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.

Detailed description

Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) or control procedures (NSMD + placebo). At baseline, 1, 3, 6 months, full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), probing depth (PD), bleeding on probing (BOP), modified gingival index (mGI), and modified plaque index (mPlI) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. The BOP reduction was set as a primary outcome and the patient was considered statistical unit. Data were analysed to assess BOP reduction at a 6-month follow-up and to identify significant predictors of implant-site BOP through mixed generalized linear regression.

Conditions

• Peri-implant Mucositis

Interventions

Type	Name	Description
OTHER	Placebo mouthwash	Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo mouthwash
OTHER	Full mouth disinfection	Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of full mouth disinfection (FMD) approach

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-02-20
• Completion: 2024-02-28
• First posted: 2023-02-03
• Last updated: 2024-09-19

Locations

1 site across 1 country: Italy