跳至主要内容
临床试验/CTRI/2023/04/052030
CTRI/2023/04/052030招募中不适用

Comparison of Bone Mineral Density and Primary Implant Stability after Socket Preservation by Calcium Phospho-silicate Putty, Sticky Bone and Natural Bone Healing: A Randomized Controlled Clinical Trial

Dr Kshipra P Kawadkar1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2023年4月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
27
试验地点
1
主要终点
1. To evaluate and compare the differences in bone mineral density by Lekholm and Zarb (1985) classification on CBCT.

研究概览

简要总结

Socket preservation is a procedure which preserves the hard as well as soft tissues of the alveolar ridge after tooth extraction. 40% bone height reduction and 60% bone width reduction occur after 6 months of extraction. Bone loss occurs more on labial surface rather than lingual or palatal surface.This alveolar ridge resorption makes it difficult or next to impossible for fabrication of implant supported prosthesis. Thakkar et al. conducted a clinical study to evaluate bone healing and soft tissue alterations after removal of teeth. The authors found that after 12 months 50% of buccolingual width of edentulous site was lost. They concluded that preservation of bone in that area is mandatory specifically if osseo-integrated implants are to be planned. Various studies have shown positive impact of using different grafts, membranes and growth factors to preserve the sockets compared to spontaneous healing. Primary implant stability is a prerequisite for a predictable, long term secondary stability (Osseo-integration), the success of secondary stability depends upon the bone quality and quantity at the receptor site. The term ‘‘bone quality’’ is not clearly defined in the literature. This includes physiological and structural aspects and the degree of bone tissue mineralization.

The present study is aimed to investigate bone mineral density (by Lekholm and Zarb classification, 1985), on Cone Beam Computed Tomography [CBCT] and primary implant stability (by Insertion Torque Value [ITV]) after three months of socket preservation with:  Nova bone putty (Group A); Sticky bone (Group B) as compared to spontaneous healing (Group C).

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants in the age range of 18 to 50 years 2)Participants having good oral hygiene 3)Presence of tooth or root piece indicated for extraction 4)Participant’s willingness for implant placement 5)Loe and Silness Gingival index less than or equal to 1.

排除标准

  • Acute infection.
  • Medically compromised patients.
  • Uncooperative patients.
  • Non-compliant patients for oral hygiene maintenance 5)Subjects with abnormal bleeding/clotting time 6)Presence of periodontal pockets 7)History Of Irradiation in Head and Neck 8)Uncontrolled diabetic patients (reported levels of glycemia over the normal threshold) 9)Current pregnancy or lactation 10) Current Smokers.

结局指标

主要结局

1. To evaluate and compare the differences in bone mineral density by Lekholm and Zarb (1985) classification on CBCT.

时间窗: 4 months after graft placement in socket the implant placement and bone density will be evaluated

2. Primary stability of implants after four months of socket preservation by nova-bone putty and sticky bone compared to spontaneous/ natural healing.

时间窗: 4 months after graft placement in socket the implant placement and bone density will be evaluated

次要结局

未报告次要终点

研究者

发起方
Dr Kshipra P Kawadkar
申办方类型
Research institution and hospital

研究点 (1)

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