Clinical Comparison Between Chlorhexidine Gel and Peribioma Periogel in Patients With Peri-implant Mucositis: a Split-mouth Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pavia
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in marginal mucosa condition
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Trial Group
Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care.
Intervention: Chlorhexidine and Biorepair gel and toothpaste application (Other)
Control Group
Patients from this group will not use chlorhexidine and Biorepair gels and toothpastes, but will perform home oral care with standard toothpastes.
Intervention: Standard oral hygiene (Other)
Outcomes
Primary Outcomes
Change in marginal mucosa condition
Time Frame: 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
Time Frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in mucosal margin
Time Frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (migrated/non migrated)
Probing Pocket Depth
Time Frame: 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)
Time Frame: 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
Time Frame: Baseline, 1, 3 and 6 months.
Dichotomous scoring (yes/no)
Change in PI - Plaque Index (percentage)
Time Frame: 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
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Andrea Scribante
Research Resident, Principal Investigator
University of Pavia