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

University of Catania

Status

Invitation-only

Conditions

Peri Implant Mucositis

Mucositis

Treatments

Other: Enamel Matrix Proteins Derivative

Other: Placebo gel

Study type

Interventional

Funder types

Other

Identifiers

NCT06725095

2024-3306

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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)