Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Periodontal Patients
NCT ID: NCT05312606
Last Updated: 2022-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2022-04-04
2022-11-05
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Trial Group
Home treatment with hyaluronic acid.
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).
Control Group
Home treatment with chlorhexidine.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* no systemic, metabolic and autoimmune disease
* compliant patients
Exclusion Criteria
* patients taking bisphosphonates in the last 12 months
* patients taking antibiotics during the study
* pregnant and breastfeeding women
* patients undergoing anticancer treatment
18 Years
70 Years
ALL
No
Sponsors
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University of Pavia
OTHER
Responsible Party
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Andrea Scribante
Associate Professor, Principal Investigator
Principal Investigators
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Andrea Scribante, DDS, PhD, MS
Role: PRINCIPAL_INVESTIGATOR
University of Pavia
Locations
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Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, Italy
Countries
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Other Identifiers
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2022-AFTORAL PARO
Identifier Type: -
Identifier Source: org_study_id