Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites
- Conditions
- Peri-implant Mucositis
- Interventions
- Other: Aftoral Oral GelOther: Unidea Chlorhexidine mouthwash
- Registration Number
- NCT05312593
- Lead Sponsor
- University of Pavia
- Brief Summary
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), after 9 months (T4) and after 12 months (T5). Professional hygiene will be performed again at 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
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), after 6 months (T3), after 9 months (T4) and after 12 months (T5).
At 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),
* Marginal mucosal condition,
* PPD (Probing Pocket Depth),
* BOP% (Bleeding on Probing),
* BS (Bleeding Score),
* Suppuration,
* PCR% (Plaque Control Record).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- age 18-70 years
- presence of at least one site suffering from peri-implant mucositis with PPD > or equal to 5 mm
- no systemic, metabolic and autoimmune disease
- compliant patients
- 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
- allergy to chlorhexidine or hyaluronic acid
- sites with peri-implantitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Trial Group Aftoral Oral Gel A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites. Control Group Unidea Chlorhexidine mouthwash A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites.
- Primary Outcome Measures
Name Time Method Change in Plaque Control Record (PCR%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) 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 x100Change in Bleeding on Probing (BOP%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total).
Formula = n ° bleeding sites / n ° probed sites x100Change in Bleeding Score (BS - Mombelli et al.) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) Scoring criteria:
0: no bleeding
1. isolated visible spots
2. blood forms a confluent red line on the mucosal margin
3. profuse and copious bleedingChange in Probing Depth (PD) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) 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.
Change in marginal mucosa condition Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) 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 probingChange in Suppuration (%) Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5) Dichotomous scoring (yes/no) of suppurating sites
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
🇮🇹Pavia, Lombardy, Italy