A clinical trial to demonstrate effectiveness of a new drill system â??Densahâ?? in increasing bone width in sites of compromised bone while placing dental implants.
- Conditions
- Health Condition 1: null- Patients with one or more missing teeth in maxilla or mandible requiring implant supported fixed restoration.
- Registration Number
- CTRI/2017/08/009496
- Lead Sponsor
- Dr Tarun Kumar AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone ridge width before and <br/ ><br>immediately after preparation of the implant site when <br/ ><br>using the Densah Bur. Timepoint: Bone ridge width will be assessed at the same day of the surgery twice. Before and <br/ ><br>immediately after preparation of the implant site <br/ ><br>using the Densah Bur.Â
- Secondary Outcome Measures
Name Time Method implant stability quotient <br/ ><br>(ISQ). ISQ uses resonance frequency analysis to determine if <br/ ><br>the newly prepared implant <br/ ><br>site is stable enough for <br/ ><br>immediate or early loading <br/ ><br>of the actual dental implant.Timepoint: ISQ will be measured on the day of the surgery immediately after implant placement and 6 weeks after main surgery.;insertion torque value(ITV).ITV is a measure of the rotational friction between the implant and the surrounding boneTimepoint: ITV will be measured on the day of the surgery at the time of implant insertion