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
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pocket Probing Depth customized using acrylic stent
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pocket Probing Depth customized using acrylic stent
时间窗: at baseline, 3 months, 6 months and 9 months
Clinical Attachment level customized using acrylic stent
时间窗: at baseline, 3 months, 6 months and 9 months
次要结局
- Gingival index (Loe and Silness-1964)(Plaque index (TURESKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN) using plaque disclosing tablets (Placksee, ICPA pvt LTD))
研究者
Mala Dixit Baburaj
Professor and Head