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

NCT ID: NCT05719181

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-06

Study Completion Date

2023-04-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Diabetes Mellitus Blood Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

two groups; first group with protein , second group without (control)
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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control group

group consist of 16 patients with no protein application

Group Type EXPERIMENTAL

rhBMP-2

Intervention Type BIOLOGICAL

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

Interventions

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rhBMP-2

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Abdullah Ali Abbas

master student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adbullah Al Abbas, B.D.S

Role: PRINCIPAL_INVESTIGATOR

University of Baghdad

Locations

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University of Baghdad

Baghdad, Alresafa, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Abdullah Al Abbas, B.D.S

Role: CONTACT

07816357260 ext. +964

Abdullah Al Abbas, B.D.S

Role: CONTACT

0781635726 ext. +964

Facility Contacts

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Abdullah Al Abbas, B.D.S

Role: primary

07816357260 ext. +964

B.D.S

Role: backup

Other Identifiers

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528622

Identifier Type: -

Identifier Source: org_study_id

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