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

NCT05312593 | Completed

• 1 other identifier: 2022-AFTORAL IMPL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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),

Conditions

Peri-implant Mucositis

Keywords

hyaluronic acid; chrlorhexidine; non-surgical periodontal therapy

Outcome Measures

Primary Outcomes (6)

• 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 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. 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 1. minimal inflammation with color change and minor edema 2. moderate inflammation with redness, edema and glazing 3. 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)

Study Arms (2)

Trial Group

EXPERIMENTAL

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

Other: Aftoral Oral Gel

Control Group

ACTIVE COMPARATOR

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

Other: Unidea Chlorhexidine mouthwash

Interventions

Aftoral Oral Gel 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).

Trial Group

Unidea Chlorhexidine mouthwash 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).

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

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

Pavia, Lombardy, 27100, Italy

Location

Study Officials

• Andrea Scribante, DDS, PhD, MS

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 5, 2022
• Study Start: April 5, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 3, 2022
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)