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

NCT04795102 | Completed

• 1 other identifier: KD/03/20
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autogenous Tooth Bone Graft; Immediate Implant Placement; L-PRF

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

L-PRF with ATBG around implant

EXPERIMENTAL

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

ATBG around implant

ACTIVE COMPARATOR

ATBG around immediately placed dental implants in the extraction sockets

Combination Product: immediate implant placement with ATBG

Interventions

immediate implant placement with ATBG and L-PRF COMBINATION_PRODUCT

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

L-PRF with ATBG around implant

immediate implant placement with ATBG COMBINATION_PRODUCT

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

ATBG around implant

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalia Rasheed Issa: lead

Study Sites (1)

Faculty of Dentistry, Kafrelsheikh University

Kafr ash Shaykh, 33511, Egypt

Location

Study Officials

• Dalia R Issa, PhD

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 7, 2021
• First Posted: March 12, 2021
• Study Start: January 1, 2020
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

EG (1)