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

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

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),

Study Overview

• Status: Completed
• Conditions: Peri-implant Mucositis
• Intervention / Treatment: Other: Aftoral Oral Gel; Other: Unidea Chlorhexidine mouthwash

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trial Group; A group of 30 patients will be randomly assigned to Hyaluronic Acid domiciliary treatment, applied into Peri-implant mucositis sites.	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).
Active Comparator: Control Group; A group of 30 patients will be randomly assigned to Chlorhexidine mouthwash domiciliary treatment, applied into Peri-implant mucositis sites.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Depth (PD)	Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal PEEK 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), 6 (T3), 9 (T4) and 12 months (T5)
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), 6 (T3), 9 (T4) and 12 months (T5)
Change in Bleeding Score (BS - Mombelli et al.)	Scoring criteria: 0: no bleeding; isolated visible spots; blood forms a confluent red line on the mucosal margin; profuse and copious bleeding	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
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), 6 (T3), 9 (T4) and 12 months (T5)
Change in marginal mucosa condition	Scoring criteria: 0: normal mucosa; minimal inflammation with color change and minor edema; moderate inflammation with redness, edema and glazing; severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)
Change in Suppuration (%)	Dichotomous scoring (yes/no) of suppurating sites	Baseline (T0), after 1 (T1), 3 (T2), 6 (T3), 9 (T4) and 12 months (T5)

Collaborators and Investigators

• Sponsor: University of Pavia
• Investigators: Principal Investigator: Andrea Scribante, DDS, PhD, MS, University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 23, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: hyaluronic acid; chrlorhexidine; non-surgical periodontal therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 2022-AFTORAL IMPL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available upon motivated request to the Principal Investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No