Surface change in tooth replacement implant to have long term success
Phase 3
- Conditions
- Health Condition 1: K053- Chronic periodontitis
- Registration Number
- CTRI/2022/04/041780
- Lead Sponsor
- core reseach grant by SERB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
good general health
non smokers or former smokers(not smoked within 6 months of study initiation)
no chronic systemic diseases
presence of hopeless teeth requiring extraction
more than 3mm of bone beyond the root apex
presence of four bony walls of the socket with or without dehiscence
Exclusion Criteria
presence of chronic systemic diseases
bruxism habit
uncontrolled diabetes
coagulation disorders
alcohol or drug abuse
reduced compliance after oral hygiene sessions
complete edentulism
mucosal diseases
pregnancy or lactation
patients withholding consent for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early Wound Healing Dynamics by measuring following clinical parameters <br/ ><br>Modified plaque index Mobelli et al 1987 <br/ ><br>Modified sulcus bleeding index Muhlemann and son 1971 <br/ ><br>Probing pocket depth by UNC 15 probe <br/ ><br>Mucosa level <br/ ><br>Resonance frequency analysis by Osstell instrument <br/ ><br>Wound healing index by Wachtel et al 2003 and patient related outcomes by 5 point Likert type scale <br/ ><br>Osseointegration by crestal bone loss by long cone parallel technique <br/ ><br>Immune-regulation by M1 M2 cytokine profiling by ProcartaPlex <br/ ><br>Timepoint: from day 0 i.e 1st patient enrollment 1 3 6 12 months for most of the parameters. RFA is done at 0 3 14 21 28th day after implant placement than 3 6 12 months and PICF samples collected at 0 3 14 21 28th days after implant placement
- Secondary Outcome Measures
Name Time Method Study the long-term effect of GPC integrated implant in maintaining peri-implant disease free status compared to control groupTimepoint: Supportive implant maintenance protocol and would be evaluated for clinical and radiographical parameters at an interval of every 06 months after study completion. The long term-evaluation of implant survival, MBL and biological complications for at least 5 years after study completion