Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mucositis
- Sponsor
- University of Catania
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Bleeding on probing (BOP) changes
- Status
- Enrolling By Invitation
- Last Updated
- 11 months ago
Overview
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.
Investigators
Gaetano Isola
Associate Professor
University of Catania
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)
Outcomes
Primary Outcomes
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
- 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)
- Patient-Reported Outcome Measures (PROMs)(6-months)