Effectiveness of 0.2% hyaluronic acid on clinical, biomolecular and microbiological parameters in type 2 diabetes mellitus patients with periodontitis: a randomized clinical trial
Not Applicable
Completed
- Conditions
- Periodontitis with diabetes mellitusNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN49272905
- Lead Sponsor
- niversity of Indonesia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
1. Age range of 40 to 65 years.
2. Diagnosed with periodontitis according to European Federation of Periodontology (EFP)
3. DM participants are required to obtain medical clearance for SRP treatment.
4. Participants are willing to participate in research and have signed an informed consent
Exclusion Criteria
1. Participants who regularly use medications known to affect microbes, including antibiotics, anti-inflammatory drugs, immunosuppressive drugs, bisphosphonates, and blood thinners
2. Individuals with bleeding disorders, mental disorders, and acute infections
3. Individuals who have received periodontal therapy within the past six months
4. Individuals that are allergic to HA gel
5. Pregnant or breastfeeding women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method At baseline and during the 4-week follow-up using clinical examination:<br>1. Bleeding on probing<br>2. Clinical attachment loss<br>3. Pocket probing depth
- Secondary Outcome Measures
Name Time Method Quantity of Pg and Fn, and the levels of proinflammatory cytokine, IL-1ß, and anti-inflammatory cytokine, IL-10, obtained from the analysis of subgingival plaque and GCF samples collected at baseline and during the 4-week follow-up period.