NCT04879446

Brief Summary

In this study, concentrated growth factor obtained by centrifuging the patient's own blood and advanced platelet-rich fibrin liquids were applied to the implant cavity and surface. Thus, it was aimed to ensure that the osseointegration process would start earlier by ensuring a faster arrival of growth factor and healing mediators in the region, and thus, the time waited for the osseointegration process and the loading of the superstructure would be shortened. In this split-mouth study, a total of 32 patients including two separate study groups in different patients and a control group were included. While the CGF liquid was applied to the implant cavities and surfaces prepared in the study group of 16 patients, A-PRF liquid was applied to the study group of the other 16 patients. Conventional implant application was performed in the control groups of both groups. The torque values during the implantation were also recorded, and Resonance Frequency measurements were performed immediately after implantation with the Penguin RFA device and at postoperative weeks 2, 4, 6 and 12.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 10, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

April 29, 2021

Last Update Submit

May 7, 2021

Conditions

Bone Loss, AlveolarResorption, BoneOsseointegration Failure of Dental Implant

Keywords

Advanced Platelet Rich FibrinConcentrated Growth FactorImplant OsseointegrationResonance Frequency Analysis

Outcome Measures

Primary Outcomes (6)

  • Torque values

    The torque values measured immediately after the implant placement.

    Immediately after surgery

  • Resonance Frequency Analysis-I

    Resonance frequency analysis is a method used to determine the primer stability in dental implants.

    Immediately after surgery

  • Resonance Frequency Analysis-II

    Resonance frequency analysis is a method used to determine the primer stability in dental implants.

    Second week

  • Resonance Frequency Analysis-III

    Resonance frequency analysis is a method used to determine the primer stability in dental implants.

    Fourth week

  • Resonance Frequency Analysis-IV

    Resonance frequency analysis is a method used to determine the primer stability in dental implants.

    Sixth week

  • Resonance Frequency Analysis-V

    Resonance frequency analysis is a method used to determine the primer stability in dental implants.

    Twelfth week

Study Arms (4)

A-PRF Test Group

EXPERIMENTAL

Advanced Platelet Rich Fibrin liquid applied into the implant cavity and implant surface. That is the only difference between A-PRF control group and A-PRF test group.

Procedure: Advanced platelet rich fibrin (A-PRF)

CGF Test Group

EXPERIMENTAL

Concentrated growth factor liquid applied into the implant cavity and implant surface. That is the only difference between CGF control group and CGF test group.

Procedure: Concentrated growth factor(CGF)

A-PRF Control Group

EXPERIMENTAL

Dental implant applications were made with traditional methods.

Procedure: Control side of advanced platelet rich fibrin study group

CGF Control Group

EXPERIMENTAL

Dental implant applications were made with traditional methods.

Procedure: Control side of concentrated growth factor study group

Interventions

Concentrated growth factor(CGF)PROCEDURE

Concentrated growth factor(CGF) liquid applied to the implant cavity and implant surface.

CGF Test Group
Advanced platelet rich fibrin (A-PRF)PROCEDURE

Advanced platelet rich fibrin (A-PRF) liquid applied to the implant cavity and implant surface.

A-PRF Test Group
Control side of concentrated growth factor study groupPROCEDURE

Traditional implant methods applied.

CGF Control Group
Control side of advanced platelet rich fibrin study groupPROCEDURE

Traditional implant methods applied.

A-PRF Control Group

Eligibility Criteria

Age38 Years - 58 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Having no systemic disorder,
  • Not being pregnant or breastfeeding,
  • Having no smoking habit,
  • Lack of continuous drug use due to chronic disease,
  • No infection in the implant site and adjacent teeth,
  • No previous implant or any augmentation procedure in the implant site,
  • Adequate bone height and thickness of the implant site,
  • The patient's acceptance and signing the informed consent form specific to our study describing the aim, duration, advantages and possible complications of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ugur Can Unlugenc

Hatay, Mustafa Kemal University Hatay, Turkey, 31060, 31060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone LossBone Resorption

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The group in which the patients were included was determined by pulling the closed envelope just before the surgery. Test side was determined by tossing a coin after the implant cavities were prepared but before the implants were placed. The examiners who carried out the measurements and analyzes were unaware of the study and the groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a split-mouth design study. This study evaluating the effects of advanced platelet-rich fibrin and concentrated growth factor liquids on dental implant osseointegration was planned as a randomized, clinical controlled and prospective study. A total of 32 patients included in our study were divided into two groups of 16. It was planned to apply 2 implants to each patient and to evaluate each patient as one side as the control and the other as the study group. In other words, while there was a study group and a control group in the CGF group, there was also a study group and a control group in the A-PRF group. The implants were placed symmetrically to the right and left of the midline by the same physician provided that they were in the same jaw.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 10, 2021

Study Start

April 10, 2020

Primary Completion

December 21, 2020

Study Completion

March 15, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations

TU(1)