Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients

Periodontal Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312606
• Other study ID #: 2022-AFTORAL PARO
• Status: Completed
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: November 5, 2022

Study information

• Verified date: December 2022
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 5, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Other:
• Aftoral 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).
• Unidea 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).

Locations

Country	Name	City	State
Italy	Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia	Pavia	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Probing Pocket Depth (PPD)	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.	Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Primary	Gingival Recession (R)	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.	Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Primary	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)
Primary	Change in Clinical Attachment Level (CAL)	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.	Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Primary	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)