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

Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Other: Chlorhexidine and Biorepair gel and toothpaste application; Other: Standard oral hygiene

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Trial Group; Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.	Other: Chlorhexidine and Biorepair gel and toothpaste application; Split-mouth application of chlorhexidine gel 1% (quadrants 1 and 4) and Biorepair Periogel (quadrants 2 and 3) after professional dental hygiene. Home oral care will be continued with chlorhexidine 0,12% gel and Biorepair Periogel in the same quadrants, for the following 15 days from the visits, together with the use of Biorepair Parodontogel toothpaste.
ACTIVE_COMPARATOR: Control Group; Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.	Other: Standard oral hygiene; Use of standard toothpastes for home oral hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in BOP - Bleeding On Probing	Dichotomous scoring (yes/no)	Baseline, 1, 3 and 6 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 and 6 months.
Change in suppuration	Dichotomous scoring (yes/no)	Baseline, 1, 3 and 6 months.
Change in marginal mucosa condition	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	Baseline, 1, 3 and 6 months.
Change in mucosal margin	Dichotomous scoring (migrated/non migrated)	Baseline, 1, 3 and 6 months.
Probing Pocket Depth	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.	Baseline, 1, 3 and 6 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 and 6 months.
Change in BS - Bleeding Score	Scoring criteria: 0: no bleeding; 1: isolated visible spots; 2: blood forms a confluent red line on mucosal margin; 3: heavy or profuse bleeding	Baseline, 1, 3 and 6 months.

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2021
• Primary Completion (ACTUAL): January 14, 2022
• Study Completion (ACTUAL): January 16, 2022

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (ACTUAL): May 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: non-surgical periodontal therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 2021-PBIMPLANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to Principal Investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No