Clinical trial

Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study of 6\12\2021 to20\4\2023

NCT05719181

Name

528622

Description

Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.

Trial arms

Trial start

2021-12-06

Estimated PCD

2023-03-18

Trial end

2023-04-20

Status

Recruiting

Phase

Early phase I

Treatment

rhBMP-2

Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .

Arms:

control group

Size

Primary endpoint

Effect of Recombinant Human Bone Morphogenetic The Primary outcome will be measuring the effect of rhBMP- 2/ACS in improving the secondary stability of dental implant by using RFA in comparison to control group.

At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.

Eligibility criteria

Inclusion Criteria: * Patients have good oral hygiene. * Systemic healthy individuals ,Age more than18 years. * Healed edentulous area for at least 6 months after tooth extraction (delayed implant protocol). * Patients have at least two missing teeth in the jaw (canine to 1st molar area) indicated for the dental implant. Exclusion Criteria: * Presence of systemic diseases preventing implantation. * Previous implantation or augmentation of the same region. * The need for additional bone augmentation procedures (such as maxillary sinus augmentation) * Partial or total edentulous ridge associated with a severe knife-edge ridge . * Acute infection or any pathological lesion a the implant site. * Allergy to one of the materials to be used during operation. * Pregnancy. * Radiation therapy, bisphosphonate drugs , Osteoradionecrosis.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'two groups; first group with protein , second group without (control)', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}

Updated at

2023-02-08

1 organization

1 product

3 indications

Organization

University of Baghdad

Product

Indication

Indication

Indication