Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06083246
• Other study ID #: 2023-IMPLGEL
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: October 2023
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: October 30, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Other:
• Hybenix gel
Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.
• Chlosite gel
Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BOP - Bleeding On Probing	Dichotomous scoring (yes/no)	Baseline, 1, 3, 6 and 9 months.
Primary	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.
Primary	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.
Primary	Change in suppuration	Dichotomous scoring (yes/no)	Baseline, 1, 3, 6 and 9 months.
Primary	Marginal mucosal migration	Dichotomous scoring (yes/no)	Baseline, 1, 3, 6 and 9 months.
Primary	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.
Primary	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.
Primary	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.
Primary	Change in Radiographic bone loss (percentage)	Quantitative evaluation of the bone loss evaluated on intraoral x-rays.	Baseline, 1, 3, 6 and 9 months.