Clinical trial

Impact of Biological Factors on Dental Implant Osseointegration

Name
MUOSU-202104
Description
The goal of this randomized controlled trial is to compare the response of different bone densities to treatment with Platelet Rich Fibrin (PRF) in patients who need treatment with dental implant. The main questions it aims to answer are: * To investigate if bone reaction to PRF differ with different bone densities. * To study the effect of PRF on dental implant healing and to assess its effectiveness in accelerating osseointegration. Participants who need treatment with dental implant will be planned to include in this study and will be asked if they are willing to participate in this study voluntarily. All the participants will be given an information sheet and a consent form which provides simple description about the present study and its importance to insure voluntary participation. The patients will be aware that they are completely free to withdraw from the research any time during the research time. Platelet Rich Fibrin will be injected inside the hole that prepared to place dental implant in. Bone density will be evaluated, degree of osseointegration will be monitored.
Trial arms
Trial start
2024-05-10
Estimated PCD
2025-05-30
Trial end
2025-07-30
Status
Not yet recruiting
Treatment
Platelet Rich Fibrin
PRF will be injected inside the hole that prepared to place dental implant
Arms:
group with PRF
Size
10
Primary endpoint
osseointegration
Immediately after surgery, after two weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks
Bone density
before surgery, with the treatment plan preparation
Eligibility criteria
Inclusion criteria * Non- smoker. * No medical history of any systemic diseases that affect the bone metabolism. * Did not receive any systemic drugs. * Has edentulous area that needs at least two successive implants. The exclusion criteria were as follows: * Systemic disease or medication compromising bone and soft tissue healing. * Pathology in the edentulous region. * Bruxism. * Disease of the oral mucosa.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Split-mouth trials', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-03-19

1 organization

1 product

1 indication

Indication
Dental Implant