EVALUATION OF NON-INCISED PAPILLAE SURGICAL APPROACH (NIPSA) FOR INTRABONY DEFECTS UTILIZING ADVANCED-PLATELET RICH FIBRIN BLOCK: A CLINICO-RADIOGRAPHIC STUDY.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. Probing depth(PD)
研究概览
简要总结
The current single arm study was designed to treat intrabony defects with Non-Incised Papillae Surgical Approach(NIPSA). The research hypothesis of the study is there is a change in change in pre and post treatment clinical and radiographic outcomes with the defect was treated with NIPSA technique along with A-PRF Black. All the patients will be undertaken for the study after the consent is obtained from the patients.
All patients will be operated under local anaesthesia with a solution of 2% lignocaine with 1:80,000 adrenaline. Anaesthesia will be administered by either nerve block or local filtration. After anaesthesia, transgingival probing will be done and intrabony defect measurements will be recorded using UNC-15 probe before the incision is placed. To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesio-distally as necessary to allow access to the defect. The tissue coronal to the incision will be raised full thickness, to maintain the pre-operative marginal tissue and the papillae architecture intact. The granulation tissue will be removed from the adjacent osseous walls by mini- five curettes. If the defect presented a lingual component, the lingual area will be instrumented through the vestibular access. The affected root (deep area of the periodontal pocket) will be scaled and planed, and calculus will be eliminated. After defect debridement and instrumentation of the root surface, 24% ethylenediaminetetraacetic acid (EDTA) will be applied to the root surface. After 2 minutes, saline irrigation will be done followed by filling of the intraosseous defect with A-PRF block. Then the incision line will be sutured (5-0, Trulene) by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.
Patients will be recalled after 14-days for suture removal and 6 months post operatively for the evaluation of the treatment outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Defects confined to anterior & premolars and periodontal probing depth greater than or equal to six millimeter.
- •2.Intrabony defects configuration including one and/or two-wall components, always involving buccal wall.
- •Intrabony defect depth greater than or equal to three millimeter..
- •all patients available for follow up.
排除标准
- •Patients on drug therapy (like bisphosphonates, antiplatelet, anticoagulants, immunosuppressants)which can affect the outcome.
- •Patients with habit of smoking, alcohol or tobacco chewing.
- •Pregnancy or lactating women.
结局指标
主要结局
1. Probing depth(PD)
时间窗: 1. at baseline | 2. six month post operative
2. Clinical Attachment level (CAL)
时间窗: 1. at baseline | 2. six month post operative
3. Defect fill using CBCT
时间窗: 1. at baseline | 2. six month post operative
4. Bone density at the centre of the defect
时间窗: 1. at baseline | 2. six month post operative
次要结局
- 1. gingival thickness analysis at the centre of the defect(at baseline and six month post operative)
研究者
Raksha Kumari
Bapuji Dental College and Hospital