Platelet-Rich Fibrin as an Adjunct to Laser Assisted New Attachment Procedure in the treatment of Periodontitis: Clinical Outcomes from a Randomized Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Probing depth(PD)
研究概览
简要总结
Patients with stage2, stage3 periodontitis will be selected from the outpatient department of Periodontology, based on inclusion and exclusion criteria. Participants with probing pocket depth of 5 mm in atleast one tooth at each side of the mouth with one residual pocket will be selected.
Fourty four participants will be selected and randomly assigned to test and control sites by computer generated randomization method.
Clinical attachment level, probing pocket depth, bleeding on probing and patient pain perception by visual analogue scale will be recorded at baseline, 3 months and 6 months.
After scaling and root planing of the selected sites in both groups. Patients will be asked to return after one week for an assessment of their oral hygiene practices and additional procedures. Two quadrants with deep periodontal pockets will be chosen in each participant. The control areas will undergo LANAP treatment alone where this procedure will be done under local anesthesia. An optic fiber tip of Diode laser measuring 0.3s is placed parallel to the root surface, to carry away the epithelium lining of the pocket in coronal to apical motion to reflect the gingival flap. The first pass laser or troughing dissipates energy at 4 W, free running 100 milliseconds pulse expels the unhealthy lining of the pocket, and the pocket is closed by compressing gingival tissues against the root surface which creates a firm fibrin clot. While the test areas will receive a combination of LANAP and PRF. The prepared PRF will be compressed to a 1 mm thickness using gentle pressure between sterile tongue depressors. The flattened PRF will then be cut into smaller pieces and inserted into the periodontal pocket, filling it from the bottom to the gum line. A dull interdental gingivectomy knife will be employed to place the PRF membrane within the pocket.
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
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Systemically healthy individuals.
- •Participants with age group of 18 to 55 years.
- •Participants with stage 2 and stage 3 periodontitis, and presence of at least one tooth at each side of the mouth with one residual pocket (PPD more than 5mm after phase 1 therapy).
排除标准
- •Systemic diseases Pregnancy and Lactating women Recent antibiotic use Using tobacco in any form.
结局指标
主要结局
Probing depth(PD)
时间窗: Baseline, 3 months,6 months)
Clinical attachment level(CAL)
时间窗: Baseline, 3 months,6 months)
次要结局
- Bleeding on probing(BOP)(Patient pain perception by visual analogue scale(VAS))
研究者
Dr A Geetha Sahithi
Narayana Dental College and Hospital
