Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites

Study Overview
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Brief Summary
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This is a randomized controlled clinical trial (RCT). After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites. Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3). Professional hygiene will be performed again at T2 and T3. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site: conditions of the marginal mucosa (swelling and erythema), migration of the marginal mucosa, PPD (Probing Pocket Depth), BOP% (Bleeding on Probing), BS (Bleeding Score), Suppuration, PCR% (Plaque Control Record),

Detailed Description
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This is a randomized controlled clinical trial (RCT). 60 patients are expected to be enrolled. After signing the informed consent, patients satisfying the inclusion criteria will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with PEEK curettes and air polishing with glycine powder. After that, the sample will be randomly divided into 2 groups based on the domiciliary assigned treatment: Aftoral® Oral Gel solution with Hyaluronic Acid, Xylitol and glycerophosphoinositol for the domiciliary use for 15 days for 2 peri-implant mucositis sites. Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration for the domiciliary application for 15 days for 2 peri-implant sites. The study will last 6 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), and after 6 months (T3). At T2 and T3, professional hygiene will be performed again. At each recall session were collected a satisfaction questionnaire of the products (taste, smell, consistency, persistence and ease of application) and the following periodontal clinical indices, using a PEEK probe on each peri-implant site: conditions of the marginal mucosa (swelling and erythema), migration of the marginal mucosa, PPD (Probing Pocket Depth), BOP% (Bleeding on Probing), BS (Bleeding Score), Suppuration, PCR% (Plaque Control Record).

Official Title
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Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites: a Randomized Clinical Trial

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Other: Aftoral Oral Gel
* Other: Unidea Chlorhexidine mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-70 years presence of 2 peri-implant mucositis sites with PPD > 5 mm no systemic, metabolic and autoimmune disease compliant patients Exclusion Criteria: absence of dental implants neurologic, psychiatric and mental diseases patients taking bisphosphonates in the last 12 months patients taking antibiotics during the study pregnant and breastfeeding women patients undergoing anticancer treatment

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>A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites. | Other: Aftoral Oral Gel<br>* Patients will use Aftoral® Oral Gel solution for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after gel solution application).<br>|
| Active Comparator: Control Group<br>A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites. | Other: Unidea Chlorhexidine mouthwash<br>* Patients will use chlorhexidine mouthwash 0,20% for the domiciliary application once a day for 15 days after the visits (no rinsing and eating for 30 minutes after mouthwash application).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Probing Pocket Depth (PPD) | Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal PEEK probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites. | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Bleeding on Probing (BOP%) | Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100 | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Bleeding Score (BS - Mombelli et al.) | Scoring criteria: 0: no bleeding isolated visible spots blood forms a confluent red line on the mucosal margin profuse and copious bleeding | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Plaque Control Record (PCR%) | Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces. Formula = n ° sites with plaque / total n ° of dental surfaces x100 | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in marginal mucosa condition | Scoring criteria: 0: normal mucosa minimal inflammation with color change and minor edema moderate inflammation with redness, edema and glazing severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in mucosal margin | Dichotomous scoring (migrated/non migrated) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 
| Change in Suppuration (%) | Dichotomous scoring (yes/no) of suppurating sites | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 

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