HypertensionPhase 1rhBMP-2NCT05719181
Effect of Recombinant Human Bone Morphogenetic Protein-2 With an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.
A Phase 1 study testing rhBMP-2 in people with Hypertension and Diabetes Mellitus, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Diabetes Mellitus, Blood Disease
- What is being tested?
- rhBMP-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIraq
- Study dates
- 6 Dec 2021to 20 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
University of Baghdad
Baghdad, Alresafa, 10011
Abdullah Al Abbas, B.D.S, 07816357260 ext. +964, abdsin333@gmail.com
B.D.S
About this study
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
Effect of Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge on Stability of Dental Implant: (Split Mouth Randomized Clinical Trial Study.
Read the 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.
- Conditions
- Hypertension, Diabetes Mellitus, Blood Disease
- Being tested
- rhBMP-2
- Medical subject headings
- Hypertension, Diabetes Mellitus, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2Biological
Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge .
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | group consist of 16 patients with no protein application Receives: Biological: rhBMP-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of surgery ,all measurment (primary stability) was taken which represented the base line data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Dec 2021
- Primary completion18 Mar 2023 (estimated)
- Study completion20 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- two groups; first group with protein , second group without (control)
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Ali Abbas, University of Baghdad
- Investigators
- Adbullah Al Abbas, B.D.S, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719181
- Sponsor's protocol ID
- 528622
- Acronym
- rhBMP-2
- Status last verified
- Jan 2023
- First submitted
- 7 Dec 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05719181
- Acronym / sponsor ID
- rhBMP-2 / 528622
- Conditions
- Hypertension, Diabetes Mellitus, Blood Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 18 Mar 2023 (estimated)
- Study completion
- 20 Apr 2023 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two groups; first group with protein , second group without (control)
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Biological: rhBMP-2group consist of 16 patients with no protein application |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhBMP-2Recombinant Human Bone Morphogenetic Protein-2 with an Absorbable Collagen Sponge . | Biological | control group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adbullah Al Abbas, B.D.S principal investigator
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rhBMP-2 in people with Hypertension and Diabetes Mellitus, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdullah Al Abbas, B.D.S (07816357260 ext. +964, abdsin313@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.