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

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Other: Placebo mouthwash; Other: Full mouth disinfection

• Registration Number: NCT05711576
• Lead Sponsor: University of Catania

Brief 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).

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.

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-03
• Study Start: 2023-03-01
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• age ≥18 years old;
• implants with smooth necks supporting cemented or screw-retained single-unit crowns with at least one BOP-positive site (Berglundh et al., 2018),
• implants placed in both maxilla and mandible
• patients with gingivitis or treated periodontitis with the absence of residual PD ≥5 mm
• presence at least of 2 mm of keratinized mucosa (KT) at implant sites

Exclusion Criteria

• presence of systemic diseases;
• pregnancy or lactating;
• use of inflammatory drugs or antibiotics within 3 months prior to study recruitment;
• implants with modified (i.e., micro-rough) necks;
• interproximal open contacts between implant restoration and adjacent teeth;
• peri-implantitis (Berglundh et al., 2018)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash	Placebo mouthwash	Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash
non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD	Full mouth disinfection	Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with full-mouth disinfection approach (FMD).

Primary Outcome Measures

Name	Time	Method
Bleeding on probing (BOP) changes	6-months	The number of implants presenting with complete absence of BOP or implants with limited extent of BOP (≤1 spot/implant-the presence of a single spot)

Secondary Outcome Measures

Name	Time	Method
Full mouth plaque score (FMPS) % changes	6-months	Changes in FMPS%
Full mouth bleeding score (FMBS) % changes	6-months	Changes in FMBS%
Probing pocket depth (PPD) changes	6-months	Changes in PPD
Plaque at implant sites according to modified gingival index (mGI) changes score	6-months	Changes in mGI 0-4 score
Plaque at implant sites according to modified plaque index (mPlI) changes score	6-months	Changes in mPlI 0-4 score

Trial Locations

Locations (1)

AOU Policlinico G. Rodolico; 🇮🇹 Catania, Italy