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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo gel | Placebo Comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with placebo |
|
| non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD | Active Comparator | Patients received a one-session of non-surgical sub-marginal peri-implant instrumentation (NSPI) with EMD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo gel | 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 gel |
| 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 | Full mouth plaque score (FMPS) % changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gaetano Isola, DDS | University of Catania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico G. Rodolico | Catania | Ct | 95124 | Italy |
Pubmed
6 months
pubmed databse
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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Sealed envelopes
| Enamel Matrix Proteins Derivative | Other | 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 |
|
| 6-months |
| 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 |
| Patient-Reported Outcome Measures (PROMs) | 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 | 6-months |
| D009057 |
| Stomatognathic Diseases |