Clinical trial NCT06309797: Effects of Interdental Brush Dipped in 0.2% Hyaluronic Acid Gel on Periodontitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Periodontitis
Hyaluronic Acid
Oral Hygiene
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, single-blinded, randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gingival index (GI)
timeFrame: Baseline-4 weeks-12 weeks
measure: Plaque index (PI)
timeFrame: Baseline-4 weeks-12 weeks
measure: Papillary bleeding index (PBI)
timeFrame: Baseline-4 weeks-12 weeks
measure: Pocket depth (PD)
timeFrame: Baseline-4 weeks-12 weeks
measure: Clinical attachment loss (CAL)
timeFrame: Baseline-4 weeks-12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi
Study officials:
affiliation: Sağlık Bilimleri Üniversitesi Gülhane Diş Hekimliği Fakültesi Periodontoloji AD
name: özlem saraç atagün, PhD
role: PRINCIPAL_INVESTIGATOR
References: