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Testing gum and bone healing after surgery for gum disease, with or without medicine support before the procedure

Effectiveness of prior local doxycycline application in periodontal sites to be treated with Guided Tissue Regeneration ? a parallel arm randomized controlled double blinded trial - DOX-GTR Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094173
Enrollment
68
Registered
2025-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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 Health Condition 2: K088- Other specified disorders of teethand supporting structures

Interventions

Intervention1: Doxycycline + Guided Tissue Regeneration (GTR with xenograft and resorbable membrane): Preoperative subgingival application of locally delivered doxycycline gel into the periodontal poc

Sponsors

Dr Athul krishna P
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged between 25 years and 60 years. Both male and female patients. Patients diagnosed with Stage III or Stage IV periodontitis with two-walled or three-walled infrabony defects, or mandibular molar Class II furcation defects. Full mouth plaque score and full mouth bleeding score less than 15 percent at the time of enrollment. At least one tooth with probing pocket depth more than or equal to 6 millimeters with the above mentioned defects. Patients willing to undergo surgical intervention and attend follow up visits

Exclusion criteria

Exclusion criteria: Patients with known allergy to doxycycline or other drugs in the same class. Smokers who consume more than ten cigarettes per day. Patients with uncontrolled diabetes that may affect periodontal healing. Pregnant or lactating women. Patients with a history of periodontal surgery in the last twelve months at the same site. Patients with poor plaque control despite oral hygiene instructions.

Design outcomes

Primary

MeasureTime frame
Clinical attachment level gain at six months post surgeryTimepoint: 6 months

Secondary

MeasureTime frame
Change in probing pocket depthTimepoint: Baseline and 6 months post surgery;Change in gingival recessionTimepoint: Baseline and 6 months post surgery ; Change in bleeding on probing score Timepoint: Baseline and 6 months post surgery;Radiographic bone fill Timepoint: Baseline and 6 months post surgery;Change in defect angle Timepoint: Baseline and 6 months post surgery;Early wound healing index Timepoint: 1 week post surgery;Post operative discomfort assessed by visual analogue scale Timepoint: 1 week post surgery;Change in Porphyromonas gingivalis load assessed by real time PCR Timepoint: Baseline and 1 month post surgery

Countries

India

Contacts

Public ContactDr BAIJU RM

GOVERNMENT DENTAL COLLEGE KOTTAYAM

baijurm2@gmail.com9447279605

Outcome results

None listed

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