AOU Policlinico G. Rodolico
Catania, 95124, Italy
NCT Number: NCT05711576
To evaluate the naturally occurring peri-implant mucositis (PM) treatment by means of non-surgical sub-marginal peri-implant instrumentation (NSPI) with or without full-mouth disinfection approach (FMD). Specifically, the primary outcome of the present study compared the efficacy of NSPI and full-mouth disinfection (FMD) with respect to NSPI and placebo in the treatment of PM at 6 months follow-up. The secondary outcome evaluated the influence of possible predictors on the BOP changes among all follow-up sessions.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Catania, 95124, Italy
Fifty-six patients with 85 Implants affected by PM were randomly assigned to test (NSMD+FMD) 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) were assessed. Furthermore, the proportions of Aggregatibacter Actynomycencomitans, Porphyromonas Gingivalis, Tannerella Forsythia and Treponema Denticola were also recorded. 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 mouthwash
Patients were treated with non surgical peri-implant mucositis therapy with non-surgical sub-marginal peri-implant instrumentation plus the use of full mouth disinfection (FMD) approach
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
Changes in FMPS%
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
University of Catania
Other
The Effect of Non-surgical Mechanical Debridement With or Without Full-mouth Disinfection in the Treatment of Peri-implant Mucositis. A Randomized Placebo-controlled Clinical Trial
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