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

NCT ID: NCT06725095

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-05
• Study Completion Date: 2025-06-05

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.

Conditions

Mucositis; Peri Implant Mucositis

Study Design

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

Study Groups

Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel

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

Group Type: PLACEBO_COMPARATOR

Placebo gel

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 gel

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

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

Group Type: ACTIVE_COMPARATOR

Enamel Matrix Proteins Derivative

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 non-surgical treatment plus Enamel Matrix Proteins Derivative

Interventions

Placebo gel

Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of a placebo gel

Intervention Type: OTHER

Enamel Matrix Proteins Derivative

Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of non-surgical treatment plus Enamel Matrix Proteins Derivative

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: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Catania

OTHER

Sponsor Role: lead

Responsible Party

Gaetano Isola

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gaetano Isola, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Catania

Locations

Policlinico G. Rodolico

Catania, Ct, Italy

Countries

Italy

Other Identifiers

2024-3306

Identifier Type: -

Identifier Source: org_study_id