Clinical trial NCT06725095: Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis
Official title: Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mucositis
Peri Implant Mucositis
Keywords: Enamel matrix derivative
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Bleeding on probing (BOP) changes
timeFrame: 6-months
Secondary outcomes:
measure: Probing pocket depth (PPD) changes
timeFrame: 6-months
measure: Full mouth plaque score (FMPS) % changes
timeFrame: 6-months
measure: Full mouth bleeding score (FMBS) % changes
timeFrame: 6-months
measure: Plaque at implant sites according to modified gingival index (mGI) changes score
timeFrame: 6-months
measure: Plaque at implant sites according to modified plaque index (mPlI) changes score
timeFrame: 6-months
measure: Patient-Reported Outcome Measures (PROMs)
timeFrame: 6-months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Policlinico G. Rodolico
state: Ct
Study officials:
affiliation: University of Catania
name: Gaetano Isola, DDS
role: PRINCIPAL_INVESTIGATOR
References: