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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06309797
Other study ID # OSATAGUN2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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