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临床试验/CTRI/2024/11/076803
CTRI/2024/11/076803尚未招募3 期

Comparative Evaluation of clinical effectiveness of titanium-prepared platelet-rich fibrin and connective tissue graft in papilla reconstruction

Dr Amrutha Rao1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
PAPILLA HEIGHT

研究概览

简要总结

Rationale:

Interdental papilla morphology is determined by factors such as age, shape of crown, contact position and angle between the roots of adjacent teeth, alveolar crest-interdental contact point distance, interdental embrasure volume, crestal bone height, soft tissue appearance, periodontal disease and history of periodontal surgery. Interdental papilla loss which leads to appearance of black triangles between teeth can cause aesthetic disorders, phonetic problems, and food accumulation (Chow et al, 2010, Sharma et al, 2010; Tarnow, 1992).

 Though various non-surgical approaches through prosthetic, restorative, and orthodontic procedures have been used for papilla reconstruction, they have not always yielded satisfactory results. Several full or partial thickness, free or pedicle tissue management surgical techniques including roll, rotated, or advanced flaps have been proposed for papilla reconstruction (Deepalakshmi, 2007; De Castro Pinto, 2010). Several studies state that Connective tissue grafts provide better results than conventional Platelet rich fibrin despite their disadvantages such as presence of a second wound site and variable papilla reconstruction outcomes.

 Tunali et al., in 2013 harnessed titanium biomedical tubes for the construction of Titanium coated titanium platelet‑rich fibrin (T‑PRF). Titanium has been more useful in stimulating platelets compared to glass tubes and forms a thicker fibrin clot exhibiting longer resorption span and profuse fibrin meshwork provoking increase cellularity at the prescribed loci thereby inducing periodontal genesis (Tunali, 2014).

 Need for the study:

With Titanium having one of the greatest bio-compatibility, the application of titanium-prepared platelet-rich fibrin involves minimally invasive technique with low risk and satisfactory clinical outcomes, but limited research is done on titanium-prepared platelet-rich fibrin. To the best of our knowledge, no studies are done to evaluate the success of titanium-prepared platelet-rich fibrin in papilla reconstruction.

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
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Teeth having contact points At least 2 mm keratinized tissue width (KTW) Probing depth (PD) ≤3 mm adjacent to the open embrasure.

排除标准

  • Patients with cardiovascular disease, type 2 diabetes mellitus, or osteoporosis Patients having anti-epileptics, immunosuppressants, corticosteroids, non- steroidal anti-inflammatory drugs or hormones Patients using tobacco/alcohol Pregnant and lactating women.

结局指标

主要结局

PAPILLA HEIGHT

时间窗: BASELINE, 1 MONTH, 3 MONTHS

次要结局

未报告次要终点

研究者

发起方
Dr Amrutha Rao
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Dr Amrutha Rao

MS Ramaiah Dental College

研究点 (1)

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