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Clinical Trials/CTRI/2024/09/074175
CTRI/2024/09/074175CompletedNot Applicable

Comparison of quality of bone formation, insertion torque and implant stability between early implant placement and delayed implant placement in sockets preserved with A-PRF A Randomized control trial

Dr Neelarchana Seelam1 site in 1 country20 target enrollmentStarted: September 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Implant stability quotients (ISQ) between early implant placement and delayed implant placement

Study Overview

Brief Summary

The success of dental implants largely depends on the quality of bone formation, the mechanical stability of the implant at the time of placement, and the long-term stability during the healing process. Bone quality and implant stability are critical determinants of osseointegration. Advanced platelet–rich fibrin (A-PRF) has emerged as a promising biomaterial for enhancing bone healing and regeneration. It contains a high concentration of growth factors and cytokines, which can accelerate tissue healing and bone regeneration. Preservation of extraction sockets using A-PRF aims to maintain the alveolar ridge’s volume and quality. This could solve ongoing debates in implant dentistry on optimal timing for implant placement following tooth extraction.This randomized control trial aimed to compare the quality of bone formation, insertion torque, and implant stability between early implant placement (EIP) at 8 weeks and delayed implant placement (DIP) at 12 weeks in extraction sockets preserved with advanced platelet-rich fibrin (A-PRF).Twenty patients requiring extractions in the maxillary premolar region will be randomized into two groups: EIP (Early Implant Placement - 8 weeks post-extraction) and DIP (Delayed Implant Placement - 12 weeks post- extraction). All the teeth will be extracted atraumatically using piezotomes, and sockets will be preserved using A-PRF. Primary outcomes of the study included histomorphometric analysis of bone, insertion torque values measured at the implant placement, and implant stability quotient (ISQ) measured at placement and after 1 and 3 months.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
20.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Patient with age 20 – 50 years
  • •American Society of Anaesthesiologists (ASA) -1 category
  • •Bilateral or unilateral with one or more teeth advised for extraction in the maxillary premolar region
  • •Non-restorable carious lesion
  • •Root resorption, root caries and root fracture with questionable prognosis
  • •Intact buccal cortical plate after extraction.

Exclusion Criteria

  • •Patients subjected to radiotherapy in the head and neck
  • •ASA – II, III, IV, V patients
  • •Patients with poor compliance
  • •Chronic smokers
  • •Medical conditions or medications known to alter soft tissue or bone healing
  • •Active local or systemic infection
  • •Roots extending into the maxillary sinus
  • •Dehiscence in buccal cortical plates after extraction.

Outcomes

Primary Outcomes

Implant stability quotients (ISQ) between early implant placement and delayed implant placement

Time Frame: At Baseline, 1 and 3 months

Secondary Outcomes

  • Quality of bone formation(Baseline - at the time of implant placement.)
  • Insertion torque(Baseline - at the time of implant placement.)

Investigators

Sponsor
Dr Neelarchana Seelam
Sponsor Class
Other [self]

Study Sites (1)

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