Treatment of Periodontal Disease With Two Different Bioactive Gels for Home Oral Care
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Periodontal Diseases
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients are divided in two groups. Both groups are treated with non-surgical periodontal therapy (baseline and 1, 3, 6 months after the first professional oral hygiene). Patients in the first group receive Biorepair gel in quadrants Q1 and Q4 and chlorhexidine 1% gel in quadrants Q2 and Q3; for patients in the second group the situation is inverted. In this way, it is possible to compare the general periodontal condition and the quadrants treated with the two different gels.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
Description
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in r...
This study is an open-label split-mouth study that aims to assess the improvement of periodontal inflammatory indices after sessions of professional oral hygiene with the administration of Biorepair Implant Bioactive Gel and Chlorhexidine gel 1%. It will also compare the efficacy of the two gel in rebalancing periodontal health. Periodontal patients that will give the informed consent to the treatment protocol and that satisfy the eligibility criteria will undergo 4 sessions of professional oral hygiene. For each session, periodontal inflammatory indices will be recorded and professional manual and mechanical removal of supragingival and subgingival deposits of both arches will be performed, following air-perio polishing with glycine powders. At this stage, patients will be randomized and allocated to the following two groups: Group 1: application in periodontal pockets of quadrants Q1 and Q3 of Biorepair Implant Bioactive Gel; irrigation of periodontal pockets of quadrants Q2 and Q4 with chlorhexidine 1% gel. Group 2: irrigation of periodontal pockets of quadrants Q1 and Q3 with chlorhexidine 1% gel; application in periodontal pockets of quadrants Q2 and Q4 of Biorepair Implant Bioactive Gel. Patients will continue with a home oral care protocol, using both gels for the same quadrants of their group for the following 14 days after the professional oral hygiene session. The first session is at the baseline (T0), the second is after 1 month (T1), the third is after 3 months (T2) and the last is after 6 months (T4).
Tracking Information
- NCT #
- NCT04781478
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Andrea Scribante, DDS, PhD. University of Pavia