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
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- Pocket Probing Depth customized using acrylic stent
Study Overview
Brief Summary
The current study is a 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) as an adjunct to mechanotherapy for the Treatment of isolated Periodontal Pockets in Patients with Chronic Periodontitis.
Primary objective: To evaluate and compare the efficacy of the novel local drug delivery system containing Tetracycline Hydrochloride Microparticles to commercially available tetracycline fibers (Periodontal AB PlusTM) as an adjunct to mechanotherapy in the management of isolated periodontal of chronic periodontitis
Study design:The study is designed an Interventional Prospective Randomized Clinical Study. It is a single-blinded, single centre, institution-based study.
The patients in Group A, [EXPERIMENTAL GROUP]
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Subgingival curettage will be done under LA infiltration (1 in 1,00,000 adrenaline) using sterile curettes.
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Tetracycline HCl Micro-particles will be placed in the curetted pockets
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Periodontal dressing (Coe-Pak) will be placed over the site.
The patients in Group B [Control GROUP]
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Subgingival curettage will be done under LA infiltration (1 in 1,00,000 adrenaline) using sterile curettes.
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Tetracycline HCl fibers (Periodontal AB Plus) will be placed in the curetted pockets
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Periodontal dressing (Coe-Pak) will be placed over the site.
· Patients will be recalled after 1 week for Periodontal dressing removal and surgical site evaluation
· Oral hygiene instructions will be reinforced
· Patients will be followed up for 1 ,3 , 9months following which the clinical parameters will be reassessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 25.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Isolated periodontal pockets 5mm to 7mm deep.
- •Patients with chronic periodontitis 3) Patient willing to give the informed consent and willing to comply with the study were selected.
Exclusion Criteria
- •Allergy or hypersensitivity to tetracycline or related compounds.
- •Use of antibiotics within last 3 months.
- •Patients not maintaining satisfactory oral hygiene after phase1 periodontal therapy.
- •Systemic diseases.
- •Pregnancy.
Outcomes
Primary Outcomes
Pocket Probing Depth customized using acrylic stent
Time Frame: at baseline, 3 months, 6 months and 9 months
Clinical Attachment level customized using acrylic stent
Time Frame: at baseline, 3 months, 6 months and 9 months
Secondary Outcomes
- Gingival index (Loe and Silness-1964)(Plaque index (TURESKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN) using plaque disclosing tablets (Placksee, ICPA pvt LTD))
Investigators
Mala Dixit Baburaj
Professor and Head