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

NCT05711576 | Completed DMC

• 1 other identifier: 150/2679/2022/PO
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Bleeding on probing (BOP) changes

  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)

  6-months

Secondary Outcomes (5)

• Probing pocket depth (PPD) changes

  6-months

• Full mouth plaque score (FMPS) % changes

  6-months

• Full mouth bleeding score (FMBS) % changes

  6-months

• Plaque at implant sites according to modified gingival index (mGI) changes score

  6-months

• Plaque at implant sites according to modified plaque index (mPlI) changes score

  6-months

Study Arms (2)

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

PLACEBO COMPARATOR

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

Other: Placebo mouthwash

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

ACTIVE COMPARATOR

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

Other: Full mouth disinfection

Interventions

Placebo mouthwash 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 placebo mouthwash

Full mouth disinfection 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

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

AOU Policlinico G. Rodolico

Catania, 95124, Italy

Location

Study Officials

• Gaetano Isola

  Università degli Studi di Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: February 3, 2023
• Study Start: March 1, 2023
• Primary Completion: February 20, 2024
• Study Completion: February 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6-months
• Access Criteria: Official university website/pubmed

Locations

IT (1)