Effectiveness of 0.2% hyaluronic acid on clinical, biomolecular and microbiological parameters in type 2 diabetes mellitus patients with periodontitis: a randomized clinical trial

The aim of this research is to assess the effectiveness of 0.2% HA gel on periodontal parameter, quantity of Pg and Fn, and the levels of proinflammatory cytokine, IL-1ß, and anti-inflammatory cytokine, IL-10, in type 2 DM patients with periodontitis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN49272905

Enrollment

Registered

2024-04-09

Start date

2023-03-06

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis with diabetes mellitus Nutritional, Metabolic, Endocrine

Interventions

This research design is a parallel, double-blind, placebo-controlled randomized controlled trial. Subjects consist of two groups: the non-DM group and the DMT2 group. Subsequently, each group will be

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Secondary

Measure	Time frame
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.	—

Primary

Measure	Time frame
At baseline and during the 4-week follow-up using clinical examination: 1. Bleeding on probing 2. Clinical attachment loss 3. Pocket probing depth	—

Countries

Indonesia

Contacts

Public ContactSri Lelyati Masulili

lelyati@ui.ac.id+62 87877178393

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026