Clinical trial

Influence of Human Platelet Derivatives on Dental Implant Osseointegration

Name

MUOSU-202103

Description

The goal of this randomized controlled trial is to evaluate the benefit of PRF membrane on bone around dental implant in patients who need treatment with dental implant. Aims of the study: * To study the effect of PRF membrane (with or without bone substitute on increasing bone dimension around dental implant. * To investigate the effects of compositions of PRF (platelets count, WBC count) on bone healing.

Trial arms

Trial start

2024-06-20

Estimated PCD

2025-05-30

Trial end

2025-07-30

Status

Not yet recruiting

Treatment

PRF membrane

Placing implant with PRF membrane treatment

Arms:

experimental group

Size

Primary endpoint

Osseointegration

Immediately after surgery, after 12 weeks (during uncover implant surgery)

Bone width

Baseline (pre-surgery), immediately after the surgery, after 4 weeks, 6 weeks, 8weeks, 10 weeks, and 12 weeks.

Eligibility criteria

IInclusion 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 dental implant. 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', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-03-19

1 organization

1 product

3 indications

Organization

Al-Mustansiriyah University

Product

Indication

Indication

Indication