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

May 30, 2025 updated by: Gaetano Isola, University of Catania

Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ct
      • Catania, Ct, Italy, 95124
        • Policlinico G. Rodolico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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
Other: 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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding on probing (BOP) changes
Time Frame: 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)
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth (PPD) changes
Time Frame: 6-months
Changes in PPD
6-months
Plaque at implant sites according to modified gingival index (mGI) changes score
Time Frame: 6-months
Changes in mGI 0-4 score
6-months
Plaque at implant sites according to modified plaque index (mPlI) changes score
Time Frame: 6-months
Changes in mPlI 0-4 score
6-months
Full mouth plaque score (FMPS) % changes
Time Frame: 6-months
Full mouth plaque score (FMPS) % changes
6-months
Full mouth bleeding score (FMBS) % changes
Time Frame: 6-months
Changes in FMBS
6-months
Patient-Reported Outcome Measures (PROMs)
Time Frame: 6-months
Patient-Reported Outcome Measures (PROMs) Were evaluated PROMs such as the number of abscesses, systemic complications, gingival recession, excessive bleeding, allergic effects, systemic impacts and related drug side effects
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Catania

Investigators

  • Principal Investigator: Gaetano Isola, DDS, University of Catania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2024

Primary Completion (Actual)

February 1, 2025

Study Completion (Estimated)

June 5, 2025

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pubmed

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

pubmed databse

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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