Comparative evaluation of clinical and radiographic outcomes of two commercially available implant systems for treating partially edentulous patients – a prospective study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- evaluation of implant
Study Overview
Brief Summary
Aim of the study is to evaluate and compare the clinical and radiographic outcomes of two different implant systems Adin and Osstem in the treatment of partially edentulous arches. All the participants will be explained the need and design of the study. Informed and written consent will obtained from the patients. Thorough clinical case history will be recorded. A full mouth supragingival and subgingival scaling and root planing procedure will be performed. 2 weeks after phase I therapy, a clinical and radiographic evaluation will be performed to confirm the suitability of the sites for this study. The selected sites will be divided randomly into A and O groups. Group A will be treated with ADIN implants, whereas group O will be treated with OSSTEM implants. Clinical parameters like pain intensity from implant region using visual analogue scale (VAS), implant stability using the first generation Osstell instrument , modified plaque index (PI) , modified sulcus bleeding index, probing pocket depth, width of masticatory mucosa (Wma) and radiographic assessment will be done. Intraoral antisepsis will be performed with 0.2% chlorhexidine digluconate rinse and an iodine solution will be used to carry out extra oral antisepsis. After administration of local anesthesia, horizontal crestal incision following, mucoperiosteal flaps will be reflected. Care will be taken to preserve as much interproximal soft tissue as possible. Sequential osteotomy will be done and suitable size implant body will be placed with the help of a rachet. The implant body will be covered by cover screw. The mucoperiosteal flaps will be repositioned and secured in place using non-absorbable black silk surgical suture. The interrupted suture will be placed. Surgery will be performed at 2 stages in both site A and O : Stage 1 – implant body will be placed covered by cover screw. Stage 2 – cover screw will be removed and healing abutment will be placed (4 months after stage 1 surgery) 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. In postoperative care antibiotics Amoxcillin 500mg tid for 5 days and analgesic diclofenac sodium 50mg + paracetamol 500mg tid for 5 days will be prescribed, along with chlorhexidine digluconate rinse twice daily for 2 weeks. Sutures will be removed after 10 days postoperatively. Each patient will be reinstructed for proper oral hygiene measures at each appointment, and re-examined at 6 months and 1 year. Soft and hard tissue evaluation will be performed at 6 months and 1year. Hard tissue evaluation will be done radiographically for the same study.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Partially edentulous patient requiring 1 or more single implant supported crown 2)Absence of any local anatomical limitations 3)Patient willing for surgery.
Exclusion Criteria
- •General contraindications to implant surgery 2)Local and systemic conditions affecting bone 3)Poor oral hygiene and motivation 4)Untreated periodontitis or acute/purulent infection in the area intended for implant placement 5)Unable to commit to 1-year follow-up 6)Treated or under treatment with intravenous amino-bisphosphonates 7)Lacking antagonistic occlusal surfaces for the study implants at implant loading 8)Implant site requiring major bone grafting procedures including sinus lift with lateral approach, minor augmentation procedures such as crestal sinus lift.
Outcomes
Primary Outcomes
evaluation of implant
Time Frame: at baseline that is after stage 1 surgery, after stage 2 surgery , 6 months and | 1 year
stability quotient
Time Frame: at baseline that is after stage 1 surgery, after stage 2 surgery , 6 months and | 1 year
Secondary Outcomes
- to evaluate marginal bone level(at baseline to one year)
Investigators
Dr Shreya Singh
SMBT dental college and hospital
