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Comparing the efficacy of two different formulations of tetracycline antibiotic when applied locally in patients with gum disease

Comparative Clinical Evaluation of the Effectiveness of a Novel Local Drug Delivery Agent Containing Tetracycline HCL Micro-particles vs Tetracyline HCL fibers (Periodontal AB plusTM) in Treatment of Periodontal Pockets in Patients with Chronic Periodontitis - Nil

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067595
Enrollment
55
Registered
2024-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: Tetracycline microparticles 2mg per pocket: as local drug delivery agent in isolated periodontal pockets to be delivered once at the base of the pocket Control Intervention1: tetracycli

Sponsors

Mala Dixit Baburaj Primary Investigator
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Isolated periodontal pockets 5mm to 7mm deep. 2) Patients with chronic periodontitis 3) Patient willing to give the informed consent and willing to comply with the study were selected

Exclusion criteria

Exclusion criteria: 1) Allergy or hypersensitivity to tetracycline or related compounds. 2) Use of antibiotics within last 3 months. 3) Patients not maintaining satisfactory oral hygiene after phase1 periodontal therapy. 4) Systemic diseases. 5) Pregnancy. 6) Smoking

Design outcomes

Primary

MeasureTime frame
Pocket Probing Depth customized using acrylic stent Clinical Attachment level customized using acrylic stentTimepoint: at baseline, 3 months, 6 months and 9 months

Secondary

MeasureTime frame
Gingival index (Loe and Silness-1964) Plaque index (TURESKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN) using plaque disclosing tablets (Placksee, ICPA pvt LTD) Timepoint: at baseline, 3 months, 6 months and 9 months

Countries

India

Contacts

Public ContactMala Dixit Baburaj
maladixit25@gmail.com9223340938

Outcome results

None listed

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