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Comparing the effect of locally delivered drugs- chitosan and tetracyline in addition to scaling and root planing in patients with type 2 diabetes mellitus

Comparison of effect of locally delivered chitosan and tetracycline hydrochloride as an adjunct to scaling and root planing in type-2 diabetes mellitus patients enrolled for periodontal maintenance- A randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058766
Enrollment
26
Registered
2023-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Chitosan membrane with scaling and root planing: After scaling and root planing, Chitosan membrane will be delivered locally into the periodontal pocket. Duration of the therapy is for

Sponsors

Nishmitha Shetty
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with type-2 diabetes with HbA1c = 7. 2) Patients who agree to participate in the study by signing the informed consent. 3) Age = 30 years, irrespective of the gender. 4) Patients diagnosed with stage II and stage III grade B periodontitis having completed active periodontal treatment at least 3-6 months prior and are receiving regularly supportive periodontal therapy (while exhibiting residual pockets of = 5 mm. 5) Full Mouth Plaque Score- less than 25% 6) Full Mouth Bleeding Score- less than 25%

Exclusion criteria

Exclusion criteria: Patients having systemic diseases other than diabetes mellitus. 2) Use of drugs such as anti-inflammatory, immune-suppressants, calcium antagonist, anti-epileptic. 3) Use of antimicrobial mouth rinses in the preceding 2 months 4) Smokers 5) Patients who were neither on antibiotic therapy nor had undergone any periodontal therapy in the past 6 months were included in the study 6) Restorations and caries in the area to be treated. 7) History of allergy of tetracycline or chitosan. 8) Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
Reduction in pocket probing depth, gain in clinical attachment level and reduction in perio-pathogensTimepoint: At baseline and at 6 months

Secondary

MeasureTime frame
Overall improvement in oral healthTimepoint: 3 MONTHS

Countries

India

Contacts

Public ContactNishmitha D Shetty

Manipal Academy of Higher Education

deepa.gkamath@manipal.edu7760343435

Outcome results

None listed

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