Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis

Not Applicable

• Conditions: Mucositis; Peri Implant Mucositis

• Registration Number: NCT06725095
• 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 use of enamel matrix protein derivative (EMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI +EMD with respect to NSPI and placebo in the treatment of PM at 6 months follow-up by means of BOP reduction. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.

Detailed Description

Patients (n° 54) with Implants affected by PM were randomly assigned to test (NSMD+EMD) 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) will assessed as well as levels of periodontal bacteria such as Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola. 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

• Status Verified: 2024-12
• Study Start: 2024-12-05
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-06-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

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

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
Probing pocket depth (PPD) changes	6-months	Changes in PPD
Full mouth plaque score (FMPS) % changes	6-months	Full mouth plaque score (FMPS) % changes
Full mouth bleeding score (FMBS) % changes	6-months	Changes in FMBS
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)

Policlinico G. Rodolico; 🇮🇹 Catania, Ct, Italy