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Clinical Trials in Italy / NCT06725095
Enrolling by invitation Not applicable

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

NCT06725095 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Catania
Phase
Not applicable
Started
2024-12-05
Last updated
2025-06-04

Condition(s) studied

MucositisPeri Implant Mucositis

Investigational drug(s) / intervention(s)

Placebo gelEnamel Matrix Proteins Derivative

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Policlinico G. Rodolico Catania Ct

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06725095 on ClinicalTrials.gov ↗ ← All trials in Italy