Effects of Enamel Matrix Derivative in the Treatment of Peri-implant Mucositis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo gel, Enamel Matrix Proteins Derivative.
- Who it may be relevant to
- Registry conditions: Mucositis, Peri Implant Mucositis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
Overview
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.
Interventions
- Other 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 - Other 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
Primary outcome measures
- Bleeding on probing (BOP) changes [Time frame: 6-months]
Secondary outcome measures (6)
- Probing pocket depth (PPD) changes [Time frame: 6-months]
- Full mouth plaque score (FMPS) % changes [Time frame: 6-months]
- Full mouth bleeding score (FMBS) % changes [Time frame: 6-months]
- Plaque at implant sites according to modified gingival index (mGI) changes score [Time frame: 6-months]
- Plaque at implant sites according to modified plaque index (mPlI) changes score [Time frame: 6-months]
- Patient-Reported Outcome Measures (PROMs) [Time frame: 6-months]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Policlinico G. Rodolico — Catania
Identifiers
NCT: NCT06725095 · 2024-3306