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),
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
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).
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).
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Change in Probing Depth (PD)
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.
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
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
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
Change in Bleeding Score (BS - Mombelli et al.)
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
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
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
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
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
Change in Suppuration (%)
Dichotomous scoring (yes/no) of suppurating sites
Time frame: Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
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