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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Other: Chlorhexidine and Biorepair gel and toothpaste application
* Other: Standard oral hygiene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trial Group<br>Patients from this group will use chlorhexidine Biorepair gel and toothpaste for home oral care. | Other: Chlorhexidine and Biorepair gel and toothpaste application<br>* 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.<br>|
| Active Comparator: Control Group<br>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<br>* Use of standard toothpastes for home oral hygiene.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-surgical periodontal therapy