Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis

March 7, 2024 updated by: Özlem SARAÇ ATAGÜN

Evaluation of the Effects of Using an Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Clinical Periodontal Parameters Among Patients With Periodontitis

This study aimed to compare the effects of using an interdental brush dipped in 0.2% HA gel with those of using a regular interdental brush on clinical periodontal parameters following SRP among patients with periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The additional use of agents with antibacterial and anti-inflammatory activities such as hyaluronic acid (HA) in treating periodontal disease has recently become popular. This study aimed to evaluate the effects of using an interdental brush dipped in 0.2% HA gel on clinical periodontal parameters.This randomized controlled trial was conducted among 33 female patients and 27 male patients with stage II/III grade A/B periodontitis. After the initial periodontal treatment, patients were randomly divided into two groups; those in the test group were asked to use an interdental brush dipped in 0.2% HA gel twice a day after brushing, while those in the control group were asked to use a regular interdental brush. Clinical periodontal parameters including the pocket depth, clinical attachment loss, gingival index, plaque index, and papillary bleeding index (PBI) were assessed at baseline and in the 1st and 3rd months after treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18-55 years of age
  2. Being systemically healthy
  3. Having periodontitis (Stage 3)
  4. Not to have used any medication in the last three months
  5. Not smoking
  6. Right-handed
  7. At least 20 natural teeth

Exclusion Criteria:

  1. Patients with interdental caries
  2. Patients with orthodontic appliances
  3. Patients with removable (partial) prostheses
  4. Patients with oral and/or peri-oral pain
  5. Patients with significant oral lesions
  6. Patients with antibiotic use in the last 3 months, pregnancy and breastfeeding
  7. Patients who have undergone periodontal treatment within the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test (HA group)
the test group were asked to brush their teeth, dip the interdental brush in HA gel, and use the dipped interdental brush.
Device: Interdental brush+HA
interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm) +20 mL of 0.2% HA gel (Gengigel; Ricerfarma, Milan, Italy)
Experimental: Control Group
the control group were asked to brush their teeth and use the interdental brush for oral hygiene.
Device: Interdental brush
interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival index (GI)
Time Frame: Baseline-4 weeks-12 weeks
Improvement in GI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Baseline-4 weeks-12 weeks
Plaque index (PI)
Time Frame: Baseline-4 weeks-12 weeks
Improvement in PI; lower scores mean a better outcome; Minimum score:0 Max.score: 5
Baseline-4 weeks-12 weeks
Papillary bleeding index (PBI)
Time Frame: Baseline-4 weeks-12 weeks
Improvement in PBI; lower scores mean a better outcome; Minimum score:0 Max.score: 3
Baseline-4 weeks-12 weeks
Pocket depth (PD)
Time Frame: Baseline-4 weeks-12 weeks
Improvement in PD; lower scores mean a better outcome
Baseline-4 weeks-12 weeks
Clinical attachment loss (CAL)
Time Frame: Baseline-4 weeks-12 weeks
Improvement in CAL; lower scores mean a better outcome
Baseline-4 weeks-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Özlem SARAÇ ATAGÜN

Investigators

  • Principal Investigator: özlem saraç atagün, PhD, Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Actual)

January 26, 2024

Study Completion (Actual)

February 5, 2024

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSATAGUN2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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