Chlorhexidine Gel and Peribioma Periogel Use in Peri-implant Mucositis Sites: a Split-mouth Randomized Clinical Trial.

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Other: Standard oral hygiene; Other: Chlorhexidine and Biorepair gel and toothpaste application

• Registration Number: NCT04899986
• Lead Sponsor: University of Pavia

Brief Summary

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.

Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups: the Trial Group will undergo a split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3, with one daily home application for the following 15 days after the visits and the use of Biorepair Parodontogel toothpaste; the control Group will not use any gels.

The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present.

Detailed Description

The aim of this study is to evaluate the efficacy of non-surgical periodontal therapy with supportive home oral care for the treatment of peri-implant mucositis.

Patients with bilateral implants with peri-implant mucositis will undergo professional dental hygiene with ultrasonic handpiece and manual scaler, followed by the application of glycine Airflow powders. Then, patients will be randomly divided into two groups:

* Trial Group: split-mouth application of chlorhexidine gel 1% for quadrants 1 and 4 and of Biorepair Periogel 0.12% for quadrants 2 and 3. Home oral care will be continued with 1 application per day of the two gels for the following 15 days after the visits for the same quadrants, and the use of Biorepair Parodontogel Toothpaste.

* Control Group: no application neither of chlorhexidine gel nor of Biorepair Periogel.

The improvement of peri-implant mucositis will be evaluated between the two groups and differences between the two gels will be assessed, if present, evaluating periodontal indices at the baseline, after three months and after six months.

Study Timeline

• Study Start: 2021-05-15
• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Status Verified: 2022-01
• Primary Completion: 2022-01-14
• Study Completion: 2022-01-16
• Last Update Submitted: 2022-01-16
• Last Update Posted: 2022-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patients (18-70 years)
• Bilateral presence of peri-implant mucositis
• Patients with high compliance

Exclusion Criteria

• Patient with cardiac pacemaker
• Patients suffering from psychological, neurological or psychiatric disorders
• Patients suffering from systemic, metabolic or autoimmune diseases
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Standard oral hygiene	Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.
Trial Group	Chlorhexidine and Biorepair gel and toothpaste application	Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.

Primary Outcome Measures

Name	Time	Method
Change in marginal mucosa condition	Baseline, 1, 3 and 6 months.	Scoring criteria: * 0: normal mucosa; * 1: minimal inflammation with color change and minor edema; * 2: moderate inflammation with redness, edema and glazing; * 3: severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Change in BOP - Bleeding On Probing	Baseline, 1, 3 and 6 months.	Dichotomous scoring (yes/no)
Change in mucosal margin	Baseline, 1, 3 and 6 months.	Dichotomous scoring (migrated/non migrated)
Probing Pocket Depth	Baseline, 1, 3 and 6 months.	Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Change in GBI - Gingival Bleeding Index (percentage)	Baseline, 1, 3 and 6 months.	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.
Change in suppuration	Baseline, 1, 3 and 6 months.	Dichotomous scoring (yes/no)
Change in PI - Plaque Index (percentage)	Baseline, 1, 3 and 6 months.	Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Change in BS - Bleeding Score	Baseline, 1, 3 and 6 months.	Scoring criteria: * 0: no bleeding; * 1: isolated visible spots; * 2: blood forms a confluent red line on mucosal margin; * 3: heavy or profuse bleeding

Trial Locations

Locations (1)

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia; 🇮🇹 Pavia, Lombardy, Italy