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

Peri-implant Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312593
• Other study ID #: 2022-AFTORAL IMPL
• Status: Completed
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: November 3, 2022

Study information

• Verified date: April 2024
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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). 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 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),

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), 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 3, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis

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 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).

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 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) 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 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) 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)
Primary	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) and 6 months (T3)
Primary	Change in mucosal margin	Dichotomous scoring (migrated/non migrated)	Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)
Primary	Change in Suppuration (%)	Dichotomous scoring (yes/no) of suppurating sites	Baseline (T0), after 1 (T1), 3 (T2) and 6 months (T3)