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CompletedNCT04795102Updated Sep 2, 2021

Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants

An interventional study of immediate implant placement with ATBG and L-PRF and immediate implant placement with ATBG in Autogenous Tooth Bone Graft, Immediate Implant Placement and L-PRF, sponsored by Dalia Rasheed Issa. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-02.

Sponsored by Dalia Rasheed Issa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2020, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

Immediate implant placement into fresh extraction sockets is gaining popularity because of fewer clinical procedures and maintenance of bone architecture compared to conventional methods, thus reducing the treatment time and increasing patient satisfaction. In addition, the survival rate of the immediate implantation is comparable to that of the healed implantation sites. Recently, ATBG made from compromised teeth was applied in bone defects and resulted in a good clinical efficacy. Moreover, it is more accepted by patients to use extracted teeth as a bone graft material, especially in the case of immediate implant placement. In 2020, Kizildağ and coworkers studied the outcome of PRF as an adjunct with ATBG on bone healing in rabbit peri-implant osseous defects. They reported that combination of ATBG with PRF contributed to significantly higher new bone formation and better bone/implant contact in rabbits with peri-implant bone defects. The main hypothesis behind this study is that using L-PRF with ATBG following immediate implant placement could promote stabilization of graft particles and enhance new bone formation with a shorter time. Therefore, the purpose of this study was to compare the clinical and radiographic outcomes of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth.

02

Conditions studied

  • Autogenous Tooth Bone Graft
  • Immediate Implant Placement
  • L-PRF
03

In context

Lead sponsor

This is the only study on the registry with Dalia Rasheed Issa as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Teeth need to be extracted for periodontal reasons with a defect of labial bone (horizontal or vertical bone defect).
  • the teeth without acute inflammation.
  • no uncontrolled systemic disease which is not suitable for implantation.
  • Good systemic and oral health.

Exclusion criteria

Exclusion Criteria:

  • patients with systemic diseases or medications known to alter healing processes
  • Psychiatric disorders.
  • Root canal treated teeth.
  • patients undergoing or who had undergone radiation therapy and chemotherapy to the head and neck region during 12 months.
  • patients with para-functional habits.
  • alcoholics.
  • drug abusers.
  • heavy smokers
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    L-PRF with ATBG around implant

    L-PRF clots to cover ATBG around immediately placed dental implants in the extraction sockets

    Combination Product: immediate implant placement with ATBG and L-PRF

  • Active comparator
    ATBG around implant

    ATBG around immediately placed dental implants in the extraction sockets

    Combination Product: immediate implant placement with ATBG

Interventions

  • Combination productimmediate implant placement with ATBG and L-PRF

    immediate implant placement using ATBG as a graft material, with L-PRF

  • Combination productimmediate implant placement with ATBG

    immediate implant placement using ATBG as a graft material without L-PRF

06

What researchers measure

Primary outcomes

  1. clinical evaluation of bone formation around immediately placed dental implants

    Changes on bone formation using ATBG with or without L-PRF around immediately placed dental implants in periodontally compromised teeth

    Time frame: 9 months

  2. radiographic outcome around immediately placed dental implants

    the radiographic outcome of ATBG on bone formation with or without L-PRF around immediately placed dental implants in periodontally compromised teeth

    Time frame: 9 months

07

Study locations

1 site
  • Faculty of Dentistry, Kafrelsheikh University
    Kafr Ash Shaykh, 33511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04795102
Lead sponsor
Dalia Rasheed Issa
Responsible party
Dalia Rasheed Issa (Director, Kafrelsheikh University) — Sponsor-investigator
First posted
Mar 12, 2021
Start date
Jan 1, 2020
Primary completion
Apr 2, 2021
Completion
Apr 2, 2021
Last update
Sep 2, 2021

Study contacts

Dalia R Issa, PhD
principal investigator · Kafrelsheikh University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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