NCT07011303

Brief Summary

Dental implants, the treatment of complete and partial edentulous cases involving the restoration of lost teeth, have become a registered and widely used treatment option. Implants: It is an ideal option for the good oral health of the person who has lost his teeth due to periodontal disease, caries, trauma, or any other reason. When teeth are missing, melting occurs in the jawbone. Following tooth extraction, the loss of the implant and the amount of melting are significantly reduced. In implant treatments, which have become widely used today, successful results depend on the ideal volume and quality of hard and soft tissues. The amount of bone present in the edentulous area is important for the indication of the implant. The aim of this study is to evaluate the histological and immunohistochemical contribution of the H-PRF (horizontal-platelet rich fibrin) material placed in the extraction sockets to the quality of the newly formed bone tissue in order to make successful implants after tooth extractions for various reasons in humans. The research hypothesis is that H-PRF will contribute positively to the healing of tooth extraction sockets.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

June 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

December 12, 2024

Last Update Submit

January 23, 2026

Conditions

Keywords

H-PRF, L-PRF, tooth extraction

Outcome Measures

Primary Outcomes (3)

  • Maximum mouth opening measurements

    Preoperative and postoperative maximum mouth opening will be measured between the lower and upper middle incisal teeth.

    Preoperative, postoperative 2nd day and 7th day

  • Pain level after extraction postoperative pain after tooth extraction

    Visual Analog Scale (VAS) will be used to assess pain.

    After 6th hour and 7th day (6th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)

  • Swelling

    Preoperative and postoperative edema will be measured according to the reference points.

    Postoperative 2nd and 7th days

Study Arms (3)

CONTROL GROUP

NO INTERVENTION

Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction.

L-PRF (leukocyte-platelet rich fibrin)

ACTIVE COMPARATOR

L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction.

Procedure: L-PRF

H-PRF (horizontal-platelet rich fibrin)

EXPERIMENTAL

H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction.

Procedure: H-PRF

Interventions

H-PRFPROCEDURE

Blood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the H-TZF device for centrifugation and the sample will be horizontally centrifuged (2200 RPMx8 min, 700g). After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and H-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days).

H-PRF (horizontal-platelet rich fibrin)
L-PRFPROCEDURE

Blood will be taken from the patient before the surgical procedure is started. The blood sample will be placed in the L-PRF device for centrifugation and the sample will be centrifuged. (2700M x 12 min, 700g) After the blood is processed for centrifugation, the surgery will begin. Surgery will be performed under local anaesthesia with articaine 2 ml 4% and epinephrine 1:100,000. All patients will be operated by the same surgeon. After local anaesthesia is achieved, tooth extraction will be started. After tooth extraction, the surgical field will be washed with sterile 0.9% saline, and L-PRF material will be placed in the area and primarily sutured with a 3.0 silk suture. All patients will be given postoperative instructions by the surgeon. Patients will be prescribed mouthwash (0.12% chlorhexidine mouthwash twice daily for 7 days).

L-PRF (leukocyte-platelet rich fibrin)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer ASA I individuals between the ages of 18-40
  • Individuals with indication for tooth extraction
  • Patients who want to have implants after tooth extraction

You may not qualify if:

  • Those who are pregnant or lactating
  • Those receiving anticoagulant or antiplatelet drug therapy
  • Those who received radiotherapy to the head and face area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Tooth LossAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth DiseasesBone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. faculty member

Study Record Dates

First Submitted

December 12, 2024

First Posted

June 8, 2025

Study Start

June 1, 2024

Primary Completion

November 1, 2024

Study Completion

April 1, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations