Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-27 @ 8:14 AM
Study NCT ID:
NCT07011303
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-08
First Post:
2024-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Sponsor:
Tokat Gaziosmanpasa University
Organization:
Study Overview
Official Title:
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
This study was planned as a prospective, randomized controlled, single-blind clinical study. The study will be conducted on patients applying to the Tokat Gaziosmanpasa University Faculty of Dentistry Oral and Maxillofacial Surgery clinic in the same clinic.
Study inclusion criteria: Volunteer ASA I individuals between the ages of 18-40
Exclusion criteria for the study: Those who are pregnant or lactating Those receiving anticoagulant or antiplatelet drug therapy Those who received radiotherapy to the head and face area Those who are allergic to local anesthetics and prescribed medications
Considering possible losses, a total of 30 volunteers will be included in the study.
Randomization: Before the operation, patients will be divided into three groups: a control group, an L-PRF (leukocyte platelet-rich fibrin) group, and an H-PRF group. The sealed envelope method will be used in the process of assigning patients to the group. Sealed envelopes of the same color will be used for each group, and the patient will not know which group he is assigned to, but the physician will know which group the patient is assigned to.
Tooth extraction will be performed on patients in each group. CBCT (cone beam computed tomography) will be taken immediately afterwards. Soft tissue healing will be evaluated in the first 7 days. CBCT will be taken again after 3 months. Dental implant operations will be performed. Bone tissue biopsies will be taken after the operation. Biopsies are not routine procedures and will be obtained from bone tissue that will be removed during the operation.
Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. There will be 10 patients in this group.
L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days, and their conditions will be evaluated.
H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days and their conditions will be evaluated.
Study inclusion criteria: Volunteer ASA I individuals between the ages of 18-40
Exclusion criteria for the study: Those who are pregnant or lactating Those receiving anticoagulant or antiplatelet drug therapy Those who received radiotherapy to the head and face area Those who are allergic to local anesthetics and prescribed medications
Considering possible losses, a total of 30 volunteers will be included in the study.
Randomization: Before the operation, patients will be divided into three groups: a control group, an L-PRF (leukocyte platelet-rich fibrin) group, and an H-PRF group. The sealed envelope method will be used in the process of assigning patients to the group. Sealed envelopes of the same color will be used for each group, and the patient will not know which group he is assigned to, but the physician will know which group the patient is assigned to.
Tooth extraction will be performed on patients in each group. CBCT (cone beam computed tomography) will be taken immediately afterwards. Soft tissue healing will be evaluated in the first 7 days. CBCT will be taken again after 3 months. Dental implant operations will be performed. Bone tissue biopsies will be taken after the operation. Biopsies are not routine procedures and will be obtained from bone tissue that will be removed during the operation.
Control Group (n=10): Patient group in which no material was placed in the extraction socket after tooth extraction. There will be 10 patients in this group.
L-PRF (Comparison Arm): The patient group in which L-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days, and their conditions will be evaluated.
H-PRF (Research Branch): The patient group in which H-PRF will be placed in the extraction socket after tooth extraction. There will be 10 patients in this group. Patients will be called on the 2nd and 7th days and their conditions will be evaluated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024/25 | OTHER_GRANT | Tokat Gaziosmanpasa University Scientific Research Fund | View |