Periodontal Diseases
Conditions
Brief summary
This randomized controlled clinical trial (RCT) aims to evaluate the adjunctive efficacy of two domiciliary treatments in patients with periodontitis undergoing non-surgical periodontal therapy. After signing the informed consent, patients satisfying the inclusion criteria will undergo professional supragingival and subgingival periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder. After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy: * Aftoral® Oral Gel containing hyaluronic acid, xylitol, and glycerophosphoinositol, applied domiciliary for 15 days. * Unidea® chlorhexidine digluconate mouthwash 0.20%, used as a domiciliary rinse for 15 days. The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3). Professional oral hygiene procedures will be repeated at T2 and T3. At each visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site: * Gingival Recession (GR) * Probing Pocket Depth (PPD) * Bleeding on Probing (BoP) * Clinical Attachment Level (CAL) * Plaque Control Record (PCR) * Tooth Mobility (TM)
Detailed description
This is a randomized controlled clinical trial (RCT). A total of 40 patients with periodontitis are expected to be enrolled. After providing written informed consent, patients meeting the inclusion criteria will undergo supragingival and subgingival professional periodontal debridement of both arches performed using ultrasonic instrumentation, manual instrumentation with Gracey curettes, and air polishing with glycine powder. All patients will be treated at the Unit of Dental Hygiene, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia (Italy). After the initial treatment, participants will be randomly allocated into two groups according to the assigned domiciliary therapy: * Aftoral® Oral Gel, containing hyaluronic acid, xylitol and glycerophosphoinositol, applied as domiciliary treatment for 15 days. * Unidea® chlorhexidine digluconate mouthwash 0.20%, used as domiciliary rinse for 15 days. The total duration of the study will be 6 months. Patients will be evaluated at the following time points: Baseline (T0); 1 month after baseline (T1); 3 months after baseline (T2); 6 months after baseline (T3). Professional oral hygiene procedures will be repeated at T2 and T3. At each follow-up visit, a patient satisfaction questionnaire regarding the assigned product (taste, smell, consistency, persistence, and ease of application) will be collected. In addition, the following periodontal clinical parameters will be recorded using a periodontal probe at each site: * Gingival Recession (GR) * Probing Pocket Depth (PPD) * Bleeding on Probing (BoP) * Clinical Attachment Level (CAL) * Plaque Control Record (PCR) * Tooth Mobility (TM)
Interventions
OTHERAftoral Oral gel
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).
OTHERUnidea Chlorhexidine digluconate mouthwash 0.20%
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).
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The examiner assessing the periodontal clinical parameters is blinded to the treatment allocation, while participants are aware of the assigned domiciliary treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* presence of periodontitis sites according to the 2017 World Workshop classification system * absence of systemic, metabolic, or autoimmune diseases * compliant patients
Exclusion criteria
* neurological, psychiatric, or mental disorders * patients taking bisphosphonates within the last 12 months * patients taking antibiotics during the study period * pregnant or breastfeeding women * patients undergoing anticancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Probing Pocket Depth (PPD) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 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. |
| Gingival Recession (R) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | Evaluation (in mm) of the displacement of marginal tissue, through a millimeter periodontal probe; it is detected from the cemento-enamel junction (CEJ) to the gingival margin. |
| Change in Bleeding on Probing (BOP%) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | Quantitative assessment (percentage) of the bleeding sites (6 per tooth in total). Formula = n ° bleeding sites / n ° probed sites x100 |
| Change in Clinical Attachment Level (CAL) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | Evaluation (in mm) of the distance of the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus or periodontal pocket, evaluated in 6 sites. |
| Change in Plaque Control Record (PCR%) | Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3) | 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 |
Countries
Italy
Contacts
PRINCIPAL_INVESTIGATORAndrea Scribante, DDS, PhD, MS
University of Pavia
Outcome results
None listed