Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

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

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.

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.

Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.

Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

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.

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

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.

Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on mucosal margin heavy or profuse bleeding

Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.

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]: i) presence of bleeding and/or suppuration on gentle probing; ii) increased probing depth compared to previous examinations; iii) presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling. In absence of previous examinations, the following criteria are considered: i) presence of bleeding and/or suppuration on gentle probing; ii) probing depths of ≥ 6 mm; iii) bone levels ≥ 3 mm apical of the most coronal portion of the intraosseous part of the implant, evaluated with intraoral x-rays with Rinn holders Exclusion Criteria: Patient with cardiac pacemaker Patients suffering from psychological, neurological or psychiatric disorders Patients suffering from systemic, metabolic or autoimmune diseases Pregnant women

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia