NCT05719181

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_1 hypertension

Timeline
Completed

Started Dec 2021

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 6, 2021

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

December 7, 2022

Last Update Submit

January 31, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Study Arms (1)

control group

EXPERIMENTAL

group consist of 16 patients with no protein application

Biological: rhBMP-2

Interventions

rhBMP-2BIOLOGICAL

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

control group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Baghdad

Baghdad, Alresafa, 10011, Iraq

RECRUITING

MeSH Terms

Conditions

HypertensionDiabetes MellitusHematologic Diseases

Interventions

Bone Morphogenetic Protein 2

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Bone Morphogenetic ProteinsTGF-beta Superfamily ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Adbullah Al Abbas, B.D.S

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Al Abbas, B.D.S

CONTACT

Abdullah Al Abbas, B.D.S

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: two groups; first group with protein , second group without (control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master student

Study Record Dates

First Submitted

December 7, 2022

First Posted

February 8, 2023

Study Start

December 6, 2021

Primary Completion

March 18, 2023

Study Completion

April 20, 2023

Last Updated

February 8, 2023

Record last verified: 2023-01

Locations