Application of new adhesive material for better bone healing around immediately placed dental implants
Phase 1
- Conditions
- Health Condition 1: K029- Dental caries, unspecified
- Registration Number
- CTRI/2024/08/072462
- Lead Sponsor
- King George Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Healthy adult patients 18 to 60 years both male and female having one or more teeth indicated for extraction are included they must be Negative for allergic testing for ABRS and ready to give written informed consent The jumping gap should be at least 2mm with all 4 cortical plate walls intact around the socket and have D1 D2 or D3 bone type
Exclusion Criteria
subjects with history of Smoking alcohol tobacco chewing drugs systemic conditions requiring medication pregnancy lactation history of allergic predisposition are excluded there should not be any acute periapical abcess or cysts existing ridge defect missing one or more cortical bone at the concerned site also mandibular anterior region and D4 bone are excluded
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the effect of ABRS on the primary stability on the dental implants placed in fresh extraction sockets <br/ ><br>To assess the effect of ABRS on crestal bone healing and regeneration <br/ ><br>To determine the quality and quantity of bone formed around the dental implants <br/ ><br>To conduct a comparative evaluation of all the above parameters with the market control <br/ ><br>Timepoint: Primary stability will be measured by Radio Frequency Analyzer RFA and insertion torque at baseline 0 <br/ ><br>The crestal bone level will be measured radiographically at 0 3 6 and 12 months and clinically by probing pocket depth assessment at 0 3 6 and 12 months <br/ ><br>For bone healing Peri ?implant crevicular fluid samples will be obtained at 3 7 & 14 days after implant placement for Multiplexing <br/ ><br>Quality of bone formed is assessed by DEXA scan at 0 3 6 and 12 months <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method to assess the effect of ABRS on secondary stability on functional loads. to assess the effect of ABRS on the maintenance and healing of soft tissue profiles around dental implant crowns. To assess the functional ability of the implant prosthesis.Timepoint: secondary stability will be measured by a radio frequency analyzer RFA at 3,6 and 12 months. <br/ ><br>soft tissue profile assessment is done by pink esthetic score at 0,7,14 and 28 days and early wound healing index at 0,3,7 and 14 days. <br/ ><br>for functional assessment, the PROM questionnaire will be filled at 1,3 and 6 months