Comparative evaluation of collagen sponge with and without human placental extract gel in the treatment of furcation defects: A randomised clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Amount of bone fill
研究概览
简要总结
Scaling and root planning will be done, oral hygiene instructions will be reinforced. Participants will be recalled after 4 weeks for re-evaluation of pocket depth. Participants with furcation defects will be chosen. Written informed consent will be taken.
Participants will be selected and randomly assigned into test and control sites by computer generated randomization method, Periodontal probing depth (PPD), clinical attachment level (CAL) will be measured using UNC-15 probe. Horizontal probing depth (HPD), will be measured using Naber’s probe by a single examiner. To standardize the Nabers probe angulation and position custom made acrylic stent will be used.
Group 1-Test site Open flap debridement and Collagen sponge and human placental extract gel.
Group 2Control site Open flap debridement and Collagen sponge
In both test and control sites Kirkland flap will be raised and thorough debridement will be done followed by placement of human placental extract gel (Placentrex® Gel, ALBERT DAVID) Aqueous extract of 0.1gm of fresh human placenta with glutamic acid, leucine and lysine) plus collagen sponge (coloplug, cologenesis health care Pvt Ltd) into the bony defect of test site and collagen sponge (coloplug, cologenesis health care) alone in the control site. Then flap will be approximated with sutures.
Post-operative instructions will be given to the participants and will be recalled after 1 week for suture removal .In case of any discomfort participants are advised to report back. Clinical parameters will be taken at baseline and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.systemically healthy individuals
- •Both males and females with age between 18 and 50 years having periodontitis with furcation defects 3.pocket depth greater than or equal to 5mm after non surgical periodontal therapy 4.Radiographic evidence of bone loss in the furcation area
- •participants who are co operative and able to come for regular follow up.
排除标准
- •pregnant and lactating women 2.who received antibiotic therapy in the previous 6 months 3.who underwent periodontal therapy in the past 6 months 4.use of tobacco in any form
- •medically compromised or under therapeutic regimen that may alter the probability of periodontal healing.
结局指标
主要结局
Amount of bone fill
时间窗: baseline and 6 months
Percentage of bone fill
时间窗: baseline and 6 months
次要结局
- Periodontal probing depth(clinical attachment level)
研究者
Dr Pallam Sravani
Narayana Dental College and Hospital