Clinical trial NCT05312606: Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients
Official title: Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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, manual instrumentation with Gracey 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 as a domiciliary application for 15 days.
* Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days.

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 Periodontal probe on each site:

* Gingival Recession (R)
* PPD (Probing Pocket Depth),
* BOP% (Bleeding on Probing),
* CAL (Clinical Attachment Level),
* PCR% (Plaque Control Record),
* Tooth Mobility.

Detailed description: This is a randomized controlled clinical trial (RCT). 40 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, 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 of the University of Pavia.

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 as a domiciliary application for 15 days.
* Unidea® Chlorhexidine digluconate Mouthwash 0,20% administration as a domiciliary application for 15 days.

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 Periodontal probe on each site:

* Gingival Recession (R),
* PPD (Probing Pocket Depth),
* BOP% (Bleeding on Probing),
* CAL (Clinical Attachment Level),
* PCR% (Plaque Control Record),
* Tooth Mobility.

Eligibility criteria: Inclusion Criteria:

* presence of periodontitis sites with PPD \> 5 mm
* no systemic, metabolic and autoimmune disease
* compliant patients

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Probing Pocket Depth (PPD)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Gingival Recession (R)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Bleeding on Probing (BOP%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Clinical Attachment Level (CAL)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
measure: Change in Plaque Control Record (PCR%)
timeFrame: Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References: