Clinical trial NCT06083246: Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis
Official title: Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Peri-Implantitis
Keywords: Chlorhexidine
Hybenix gel
Domiciliary treatments
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in BOP - Bleeding On Probing
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in GBI - Gingival Bleeding Index (percentage)
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in marginal mucosa condition
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in suppuration
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Marginal mucosal migration
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Probing Depth
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in BS - Bleeding Score
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in PI - Plaque Index (percentage)
timeFrame: Baseline, 1, 3, 6 and 9 months.
measure: Change in Radiographic bone loss (percentage)
timeFrame: Baseline, 1, 3, 6 and 9 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: