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临床试验/CTRI/2017/09/009867
CTRI/2017/09/009867已完成2 期

A Clinical and radiographic study on comparison of microsurgical and macrosurgical technique using bioactive synthetic bone graft and collagen membrane for socket augmentation - A Randomized Controlled Clinical Trail .

Teethanker Mahaveer University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年8月24日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Crestal height

研究概览

简要总结

Aim and Objectives of the study: A Randomized ControlledClinical study was conducted to evaluate and compare the efficacy of Microsurgical over Macrosurgical technique usingSynthetic NanocrystallineHydroxyapatite (Sybograf- plus™) andβ-tricalcium phosphate Composite bone graft and bioresorbable collagenmembranes made of Type – I collagen (Healiguide) TM for socket augmentation

Materialsand Methods: A total of30extraction sites from 9 patients, aged 30 to 55 years were selected foraugmentation of socket immediately after the tooth extraction. Equal number of sites were selectedfrom each patients and randomly divided into Control (Macrosurgical) sites and Test(Microsurgical) sites. The clinical evaluation of Test and Control sites wasdone at baseline, 3, 6 and 9 months for Mesiobuccal, MidBuccal, Distobuccaland MidLingual/Palatal measurements.Post-operative vascularity was evaluated by Ultrasound Doppler Flowmetry atbaseline, 10th Day and 1 month. Radiological assessment was done at baseline,6 and 9 months for socket height, Buccolingual width at1/4th , 1/2 and 3/4th height of  the socket, mesio-distalwidth of the socket and the bone density recorded at apical, middle andcoronal, buccal, palatal, mesial and distal wall of socket on Dentascan inHounsfield units (HU).

**Results:**Increase insocket height was observed in Test sockets at 9 months which was statistically significantas compared to Control ones.Test group demonstrated better vascularization as compared to Controlgroup at 10 day and 1 month and all changes are statistically significant in Testgroup (p<0.05) . Boneformation and density (HU) was found to be significantly higher in Test group (p= .000) as compared to Control group both at 6 months as well as at 9 months.

·        Conclusion: SignificantGain in alveolar bone height was observed at the end of nine months in both Testand Control groups clinically.

·        Ultrasound Doppler Flowmetry revealedsuperior vascularization of Microsurgically/Test treated sites in initial phaseof wound healing than the traditional /Conventional/Control one.

·        Extended surgical time of Microsurgicalapproach was compensated for faster vascularization with rapid healing of siteleading to more predictable gingival contour with improved esthetic outcomethan the Control one. Substantial enhancement of immediate postsurgicalesthetics of a Microsurgical site to that of Macrosurgical one wasdemonstrated.

·        Radiographically, sagittal sectionsconfirmed significant increase in the socket height and buccolingual width onCT scan with significant increase in the density of bone in both Test andControl groups.

 **Keywords:**Biphasic hydroxyapatite; Collagen membrane; Dentascan; Microsurgical; Socketaugmentation; Ultrasound Doppler Flowmetry.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • 1 Sockets of extracted teeth having atleast 7mm residual alveolar bone height as measured clinically and radiographically with intact socket walls.
  • 2 Anterior teeth with grade 3 mobility and having hopeless prognosis 3 No systemic disorders.

排除标准

  • 1 Any systemic diseases where periodontal surgery is contraindicated.
  • 2 History of drug allergy.
  • 3 Pregnant patients.
  • 4 Smoking or tobacco chewing.
  • 5 Presence of periapical pathology 6 Root surface restorations.
  • 7 Root caries that would require restorations.
  • 8 Failure to complete the informed consent.

结局指标

主要结局

Crestal height

时间窗: (all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual

时间窗: (all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

Color Doppler Flowmetry ( in PSV)

时间窗: (all in milli meters) at Baseline, at 10 Day, at 1,3, 6,9 and 12 Months

次要结局

  • Crestal height(Mesiobuccal, Mid Buccal, Distobuccal, and Midlingual)

研究者

发起方
Teethanker Mahaveer University
申办方类型
Research institution and hospital

研究点 (1)

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