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

Effect of "Autogenous Leukocyte Platelet Rich Fibrin- Tooth Graft" Combination Around Immediately Placed Implants in Periodontally Compromized Sites: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Immediate Implant Placement; Autogenous Tooth Bone Graft; L-PRF
• Intervention / Treatment: Combination product: immediate implant placement with ATBG and L-PRF; Combination product: immediate implant placement with ATBG

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt, 33511
    • faculty of dentistry, kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; immediate implant placement using ATBG as a graft material, with L-PRF
Active Comparator: ATBG around implant; ATBG around immediately placed dental implants in the extraction sockets	Combination product: immediate implant placement with ATBG; immediate implant placement using ATBG as a graft material without L-PRF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 months
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	9 months

Collaborators and Investigators

• Sponsor: Dalia Rasheed Issa

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 2, 2021
• Study Completion (Actual): April 2, 2021

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: KD/03/20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No