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The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.
Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybenix gel | Experimental | Clinical application of Hybenix gel. |
|
| Chlosite | Active Comparator | Clinical application of Chlosite gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybenix gel | Other | Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BOP - Bleeding On Probing | Dichotomous scoring (yes/no) | Baseline, 1, 3, 6 and 9 months. |
| Change in GBI - Gingival Bleeding Index (percentage) | Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100. | Baseline, 1, 3, 6 and 9 months. |
| Change in marginal mucosa condition | Scoring criteria: 0: normal mucosa
| Baseline, 1, 3, 6 and 9 months. |
| Change in suppuration | Dichotomous scoring (yes/no) | Baseline, 1, 3, 6 and 9 months. |
| Marginal mucosal migration | Dichotomous scoring (yes/no) | Baseline, 1, 3, 6 and 9 months. |
| Probing Depth | Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites. | Baseline, 1, 3, 6 and 9 months. |
| Change in BS - Bleeding Score |
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Inclusion Criteria:
- Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Scribante, DDS, PhD, MSc | University of Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia | Pavia | Lombardy | 27100 | Italy |
Data will be available upon motivated request to the Principal Investigator.
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Chlosite gel | Other | Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites. |
|
Scoring criteria:
0: no bleeding
| Baseline, 1, 3, 6 and 9 months. |
| Change in PI - Plaque Index (percentage) | Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. | Baseline, 1, 3, 6 and 9 months. |
| Change in Radiographic bone loss (percentage) | Quantitative evaluation of the bone loss evaluated on intraoral x-rays. | Baseline, 1, 3, 6 and 9 months. |