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

NCT06725095 | Enrolling By Invitation

• 1 other identifier: 2024-3306
• Study Type: interventional
• Target: 54
• 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 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.

Conditions

Mucositis; Peri Implant Mucositis

Keywords

Enamel matrix derivative

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 (6)

• 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)

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

PLACEBO COMPARATOR

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

Other: Placebo gel

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

ACTIVE COMPARATOR

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

Other: Enamel Matrix Proteins Derivative

Interventions

Placebo gel 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

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

Enamel Matrix Proteins Derivative 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

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

Eligibility Criteria

• Age: 18 Years - 75 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)

Policlinico G. Rodolico

Catania, Ct, 95124, Italy

Location

MeSH Terms

Conditions

Mucositis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gaetano Isola, DDS

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 5, 2024
• Primary Completion: February 1, 2025
• Study Completion: June 5, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6 months
• Access Criteria: pubmed databse

Locations

IT (1)