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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)

Primary Purpose

Hypertension, Diabetes Mellitus, Blood Disease

Status
Recruiting
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
rhBMP-2
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypertension

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of BaghdadRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

control group

Arm Description

group consist of 16 patients with no protein application

Outcomes

Primary Outcome Measures

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.
The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2022
Last Updated
January 31, 2023
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05719181
Brief Title
Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.
Acronym
rhBMP-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
March 18, 2023 (Anticipated)
Study Completion Date
April 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes Mellitus, Blood Disease

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
two groups; first group with protein , second group without (control)
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Experimental
Arm Description
group consist of 16 patients with no protein application
Intervention Type
Biological
Intervention Name(s)
rhBMP-2
Intervention Description
Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .
Primary Outcome Measure Information:
Title
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.
Description
The topical application of rhBMP-2 in the osteotomy site has an effect through improve secondary stability of the dental implant.
Time Frame
At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Al Abbas, B.D.S
Phone
07816357260
Ext
+964
Email
abdsin313@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah Al Abbas, B.D.S
Phone
0781635726
Ext
+964
Email
abdsin313@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adbullah Al Abbas, B.D.S
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Baghdad
City
Baghdad
State/Province
Alresafa
ZIP/Postal Code
10011
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Al Abbas, B.D.S
Phone
07816357260
Ext
+964
Email
abdsin333@gmail.com
First Name & Middle Initial & Last Name & Degree
B.D.S

12. IPD Sharing Statement

Learn more about this 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.

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