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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309797
• Other study ID #: OSATAGUN2
• Status: Completed
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: March 2024
• Source: Saglik Bilimleri Universitesi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 5, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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)
• Interdental brush
interdental brushes (TePe Munhygienprodukter AB, Malmö; TePe 0.4 mm and TePe 0.6 mm)

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri Üniversitesi Gülhane Dis Hekimligi Fakültesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Özlem SARAÇ ATAGÜN

Country where clinical trial is conducted

Turkey, 

Outcome

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