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

January 31, 2023 updated by: Abdullah Ali Abbas, University of Baghdad

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Secondary outcome association of the effect of other factors (ridge dimension, bone density) on dental implant stability.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Alresafa
      • Baghdad, Alresafa, Iraq, 10011
        • Recruiting
        • University of Baghdad
        • Contact:
        • Contact:
          • B.D.S

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: control group
group consist of 16 patients with no protein application
Biological: rhBMP-2
Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.
The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.
At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Adbullah Al Abbas, B.D.S, university of Baghdad, college of dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 6, 2021

Primary Completion (ANTICIPATED)

March 18, 2023

Study Completion (ANTICIPATED)

April 20, 2023

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 8, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 528622

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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