Domiciliary Use of Hyaluronic Acid Gel Solutions vs Domiciliary Use of Chlorhexidine Mouthwash 0,20% for the Management of Peri-implant Mucositis Sites

NCT ID: NCT05312593

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-05
• Study Completion Date: 2022-11-03

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 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),

Detailed Description

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).

Conditions

Peri-implant Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Trial Group

A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites.

Group Type: EXPERIMENTAL

Aftoral Oral Gel

Intervention Type: OTHER

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

A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites.

Group Type: ACTIVE_COMPARATOR

Unidea Chlorhexidine mouthwash

Intervention Type: OTHER

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

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).

Intervention Type: OTHER

Unidea Chlorhexidine mouthwash

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age 18-70 years
• presence of at least one site suffering from peri-implant mucositis with PPD > or equal to 5 mm
• no systemic, metabolic and autoimmune disease
• compliant patients

Exclusion Criteria

• absence of dental implants
• 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
• allergy to chlorhexidine or hyaluronic acid
• sites with peri-implantitis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pavia

OTHER

Sponsor Role: lead

Responsible Party

Andrea Scribante

Associate Professor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Scribante, DDS, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pavia

Locations

Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Pavia, Lombardy, Italy

Countries

Italy

Other Identifiers

2022-AFTORAL IMPL

Identifier Type: -

Identifier Source: org_study_id