Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

Study Overview
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Brief Summary
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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: Chlosite® gel application in the peri-implant sulcus Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus. 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.

Detailed Description
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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: BOP (Bleeding On Probing) GBI (Gingival Bleeding Index) Marginal Mucosal Conditions (swelling and erythema) Suppuration Mucosal margin migration PPD (Probing Pocket Depth) PI (Plaque Index) BS (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: Chlosite® gel application in the peri-implant sulcus Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus. 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.

Official Title
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Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Other: Hybenix gel
* Other: Chlosite gel


Participation Criteria
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Eligibility Criteria
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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: Patient with cardiac pacemaker Patients suffering from psychological, neurological or psychiatric disorders Patients suffering from systemic, metabolic or autoimmune diseases Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybenix gel<br>Clinical application of Hybenix gel. | Other: Hybenix gel<br>* Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.<br>|
| Active Comparator: Chlosite<br>Clinical application of Chlosite gel. | Other: Chlosite gel<br>* Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 minimal inflammation with color change and minor edema moderate inflammation with redness, edema and glazing severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing | 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 | Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on mucosal margin heavy or profuse 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Hybenix gel, Domiciliary treatments