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Clinical Trials/NCT05517733
NCT05517733
Completed
Not Applicable

ASSESSMENT OF SOFT TISSUE HEALING OVER IMMEDIATELY PLACED IMPLANT SEALED WITH PLATELETS RICH FIBRIN (PRF) VERSUS DIODE LASER (A RANDOMIZED CONTROLLED CLINICAL TRIAL)

Nourhan M.Aly1 site in 1 country16 target enrollmentJune 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Immediate Implant Soft Tissue Healing
Sponsor
Nourhan M.Aly
Enrollment
16
Locations
1
Primary Endpoint
Mid-buccal soft tissue thickness
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Aim of the current study was to assess the efficacy of PRF in comparison to diode laser to promote tissue healing and soft tissue quality after placement of immediate implants.

Registry
clinicaltrials.gov
Start Date
June 10, 2021
End Date
June 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Nourhan M.Aly
Responsible Party
Sponsor Investigator
Principal Investigator

Nourhan M.Aly

Assistant Lecturer of Dental Public Health

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • Any non-restorable hopeless tooth: a badly decayed tooth that cannot be restored, tooth with failed endodontic treatment, and teeth with longitudinal fracture.
  • Post-extraction sockets type 1 with all bony walls intact; Type I extraction sockets according to Elian classification in 2007 have an intact labial plate of the bone and no soft tissue recession. Therefore, it does not require a mucoperiosteal flap elevation, only bone graft particles are packed into the socket after atraumatic extraction and socket debridement, then sealed with barrier membranes or soft tissue grafts.
  • No signs of active periodontal disease in the selected tooth.
  • Good oral hygiene

Exclusion Criteria

  • The presence of any systemic disease could complicate bone or soft tissue healing after immediate implant placement.
  • The presence of Acute periapical infection.
  • The presence of any local factor that may interfere with extraction as tooth ankyloses
  • Subjects who had undergone therapeutical radiation. (187)
  • Patients who had been subjected to or who were under bisphosphonate therapy

Outcomes

Primary Outcomes

Mid-buccal soft tissue thickness

Time Frame: up to 8 weeks

Measured from the gingival margin to implant platform using a periodontal probe.

Mid-crestal soft tissue height

Time Frame: up to 8 weeks

Measured using a periodontal probe passing through soft tissue in the intersection midpoint of both buccolingual and mesiodistal dimensions of the socket till cover screw.

Soft tissue healing

Time Frame: up to 4 weeks

This was done using Landry healing index. It evaluates the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration. The score ranges from 1 (Very poor) to 5 (Excellent).

Secondary Outcomes

  • Post-operative pain level(24 hours)

Study Sites (1)

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