Policlinico G. Rodolico
Catania, Ct, 95124, Italy
NCT Number: NCT06725095
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Catania, Ct, 95124, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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)
Time frame: 6-months
Changes in PPD
Time frame: 6-months
Full mouth plaque score (FMPS) % changes
Time frame: 6-months
Changes in FMBS
Time frame: 6-months
Changes in mGI 0-4 score
Time frame: 6-months
Changes in mPlI 0-4 score
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
University of Catania
Other
Effects of Enamel Matrix Derivative in the Non-surgical Mechanical Debridement Treatment of Peri-implant Mucositis
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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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