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Enrolling by Invitation

NCT Number: NCT06725095

Effects of Enamel Matrix Derivative in the 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico G. Rodolico

Catania, Ct, 95124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Probing pocket depth (PPD) changes

    Time frame: 6-months

    Changes in PPD

  2. Full mouth plaque score (FMPS) % changes

    Time frame: 6-months

    Full mouth plaque score (FMPS) % changes

  3. Full mouth bleeding score (FMBS) % changes

    Time frame: 6-months

    Changes in FMBS

  4. Plaque at implant sites according to modified gingival index (mGI) changes score

    Time frame: 6-months

    Changes in mGI 0-4 score

  5. Plaque at implant sites according to modified plaque index (mPlI) changes score

    Time frame: 6-months

    Changes in mPlI 0-4 score

  6. 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

Sponsors and collaborators

Lead sponsor

University of Catania

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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