CTRI/2024/01/061312
Not yet recruiting
Phase 3
Comparative Evaluation of Tissue Healing By using Sohn’s Poncho Technique vs Conventional Technique In Immediate Dental Implants Placed In Esthetic Zone – A Randomised Controlled Trial
Dr. Korambeth Shreeya Manojkumar1 site in 1 country38 target enrollmentStarted: January 15, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Dr. Korambeth Shreeya Manojkumar
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Evaluation of soft tissue healing around immediate dental implants placed in esthetic zone
Overview
Brief Summary
| In the past few decades, Implant therapy has evolved as a successful treatment for edentulism whether partial or complete. Replacement of missing tooth with implants has added advantages over other options such as removable partial denture or fixed partial denture which include preservation of alveolar crest and elimination of need to restore neighbouring teeth along with advantage of improved esthetics and functions. The original protocol suggested placement of implants after a healing period of 3-6 months following tooth extraction. Conventional loading protocols have prolonged healing periods which is troublesome to the patient because of functional and esthetic reasons. Dental implants can also be placed immediately after tooth extraction. Immediate implants allow placement of the implant at the same visit at which the tooth is extracted, which helps to reduce the number of surgical procedures and hence the overall treatment time. They also help to preserve alveolar width and height. When an implant is placed in a fresh extraction socket, a gap may occur between the implant surface and the bony socket wall. While delayed implants offers the time required for soft tissue to grow into the extraction socket making their attachment to implants more predictable, immediate implants poses a significant risk of bacterial contamination because of insufficient soft tissue volume. PRF (platelet rich fibrin) has been recently indicated as an aid for promoting hard and soft tissue regeneration. It is a second generation of platelet derivative enriched with platelets, leukocytes and growth factors . It also contains all the molecular and cellular elements required for optimal healing. Sohn’s poncho technique is a surgical method that utilizes the healing capacity of PRF (platelet rich fibrin) or CGF(concentrated growth factor) membranes through stabilizing the membrane with help of healing or prosthetic abutment at implant site in order to perform minimally invasive GBR (guided bone regeneration) procedure.. After extensive search of literature no study was found comparing Sohn’s Poncho technique with the conventional technique of immediate dental implant placement in esthetic zone. Thus, this study aims to establish a comparison and highlight the merit (if any) of any one technique. Primary hypothesis: There is statistically significant difference in tissue healing of immediate dental implants placed using Sohn’s Poncho technique and conventional technique in esthetic zone. Null Hypothesis: There is no statistically significant difference in tissue healing of immediate dental implants placed using Sohn’s Poncho technique and conventional technique in esthetic zone |
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •a)Systemically healthy patients requiring and opting dental implants for replacement of missing teeth in anterior esthetic zone b) Patients above 18yrs of age c) Good oral hygiene and periodontal status.
Exclusion Criteria
- •Patient with systemic disease that contraindicates the surgery immunocompromised patients 2)Pregnant or lactating females 3)History of radiotherapy smokers parafunctional habits acute and chronic infection 4)Noncompliant patients 5)Active pathology associated with site of interest.
Outcomes
Primary Outcomes
Evaluation of soft tissue healing around immediate dental implants placed in esthetic zone
Time Frame: assessment at 3 and 6 months post implant placement
Secondary Outcomes
- Evaluation of hard tissue healing around immediate dental implants placed in esthetic zone(Assessment post implant placement and post 6 months)
Investigators
Dr. Korambeth Shreeya Manojkumar
Government dental college and hospital, Nagpur
Study Sites (1)
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