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

NCT ID: NCT05711576

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-02-28

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). 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash

Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash

Group Type: PLACEBO_COMPARATOR

Placebo mouthwash

Intervention Type: OTHER

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

non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD

Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with full-mouth disinfection approach (FMD).

Group Type: ACTIVE_COMPARATOR

Full mouth disinfection

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Catania

Locations

AOU Policlinico G. Rodolico

Catania, , Italy

Countries

Italy

Other Identifiers

150/2679/2022/PO

Identifier Type: -

Identifier Source: org_study_id