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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash | Placebo Comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo mouthwash |
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| non-surgical sub-marginal peri-implant instrumentation (NSPI) with FMD | Active Comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with full-mouth disinfection approach (FMD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo mouthwash | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing (BOP) changes | 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) | 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth (PPD) changes | Changes in PPD | 6-months |
| Full mouth plaque score (FMPS) % changes | Changes in FMPS% | 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola | Università degli Studi di Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico G. Rodolico | Catania | 95124 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39865359 | Derived | Isola G, Polizzi A, Santagati M, Alibrandi A, Iorio-Siciliano V, Ramaglia L. Effect of Nonsurgical Mechanical Debridement With or Without Chlorhexidine Formulations in the Treatment of Peri-Implant Mucositis. A Randomized Placebo-Controlled Clinical Trial. Clin Oral Implants Res. 2025 May;36(5):566-577. doi: 10.1111/clr.14405. Epub 2025 Jan 25. |
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Results and clinical protocol
6-months
Official university website/pubmed
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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.
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Sealed envelopes
| Full mouth disinfection | Other | 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 |
|
| Full mouth bleeding score (FMBS) % changes | Changes in FMBS% | 6-months |
| Plaque at implant sites according to modified gingival index (mGI) changes score | Changes in mGI 0-4 score | 6-months |
| Plaque at implant sites according to modified plaque index (mPlI) changes score | Changes in mPlI 0-4 score | 6-months |