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临床试验/CTRI/2017/08/009496
CTRI/2017/08/009496招募中Unknown

Novel Implant Site preparation using Densah Burs Osseodensification: A Clinical study

Dr Tarun Kumar AB1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年3月8日最近更新:

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
using the Densah Bur.Â

研究概览

简要总结

Need for the study

Endosseous dental implants arenow considered to be the treatment of choice for replacement of all forms oftooth loss. An essential condition for successful implant therapy is thepresence of an adequate quantity and quality of bone.  If a tooth or teeth have been missing for aconsiderable period of time, or if there has been traumatic loss of tooth andbone, placement of implants may prove challenging and often requires elaboratebone-grafting procedures. Unfortunately, bone-grafting techniques require alonger treatment time, a need for a second surgical appointment, and anadditional surgical site if autogenous bone is used1.Thisis more important in recent days due to popular immediate loading protocolsbeing implemented into treatment by many clinicians.

Standarddrill designs used in dental implantology are made to excavate bone to createroom for implant placement. They cut away bone effectively but typically do notproduce a precise circumferential osteotomy. Osteotomies may become elongatedand elliptical due to chatter of the drills. In these circumstances, theimplant insertion torque is reduced leading to poor primary stability andpotential lack of integration. Osteotomies drilled into narrow bone locationsmay produce dehiscence, buccally or lingually, which also reduces primarystability and will require an additional bone grafting. For more than a decade,clinicians have been asking for improvement in bone drilling and preparation. 2Improvementsin surgical technique will present better prospects for improving clinicalresults.3Unlike standard surgical technique, bone condensingtechnique aims to maintain most of the existing bone and to compress itapicolaterally. Thicker trabeculae and reduced intertrabecular spaces mean enhancedmicrostructure of local bone that improves primary implant stability allowingearlier new bone formation.4

Dr.Salah Huwais came up with the concept of osseodensification, a novelbiomechanical implant site preparation technique. It produces low plasticdeformation of bone due to its non-excavation osteotomy preparation methodleading to expansion of pilot hole. Preservation of bone bulk takes placeduring drilling, so bone tissue is simultaneously compacted. and autografted inan outwardly expanding direction to form the osteotomy. It is accomplished byusing multifluted proprietary densifying burs- Densah Burs. 5

To the best of our knowledge veryfew studies have been conducted to know about the efficacy of Densah burs inachieving Osseodensification. Our study will be an effort in this direction.

**1.**Research hypothesis (H1) :

Densah Bur results in increasedbone ridge width while maintaining Implant stability.

**2.**Null hypothesis (H0) :

Densah Bur does not resultin increased bone ridge width while maintaining Implant stability.

Objectives of the study

1)     To evaluate Boneridge width before and immediately after preparation of the implant site whenusing the Densah Bur .

2)     To evaluateinsertion torque value (ITV) of implant.

3)     To evaluate implantstability quotient (ISQ).

CLINICAL PARAMETERS :

At the baselinevisit the study outcome data will be collected; including:

  1. Measuring the bone ridge width, priorand post implant site preparation (drilling) at two levels- crestal & aposition 10 mm apical to the crest using bone gauge.

  2. Intraoral photographs of the preparedopening

  3. Dental implant torque readings will beobtained post implant placement (ITV) (in Ncm).

  4. ISQ as measure of both initial and thedynamic development of osseointegration

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients having atleast one edentulous site with healthy adjacent teeth.
  • 2.Edentulous ridge width of atleast 3mm as determined from CBCT 3.Patients with good oral hygiene (Oral Hygiene Index Simplified < 1.3) 4.Patients having good systemic health with no contradiction for implant surgery like uncontrolled diabetes, uncontrolled hypertension.
  • 5.Capable of giving informed consent.

排除标准

  • 1.An immunocompromised medical history that would complicate the outcome of the procedure.
  • 2.Patient smoking more than 5 cigarettes per day 3.Patient has a history of alcoholism or drug abuse during the last 5 years 4.Insufficient interarch space to accommodate the prosthodontics component.
  • 5.Dental history of bruxism, Para functional oral habit and /or lack of stable posterior occlusion.
  • 6.Pregnant and /or lactating mothers.
  • 7.Patients who are uncooperative.

结局指标

主要结局

using the Densah Bur.Â

时间窗: Bone ridge width will be assessed at the same day of the surgery twice. Before and | immediately after preparation of the implant site | using the Densah Bur.Â

Bone ridge width before andÂ

时间窗: Bone ridge width will be assessed at the same day of the surgery twice. Before and | immediately after preparation of the implant site | using the Densah Bur.Â

immediately after preparation of the implant site whenÂ

时间窗: Bone ridge width will be assessed at the same day of the surgery twice. Before and | immediately after preparation of the implant site | using the Densah Bur.Â

次要结局

  • insertion torque value(ITV).ITV is a measure of the rotational friction between the implant and the surrounding bone(ITV will be measured on the day of the surgery at the time of implant insertion)
  • implant stability quotientÂ((ISQ). ISQ uses resonance frequency analysis to determine ifÂ)

研究者

发起方
Dr Tarun Kumar AB
申办方类型
Other [self]

研究点 (1)

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