Partial EdentulismPhase 1/2NCT04140006
Efficacy of Antiresorptive and Bone Forming Material on Dental Implants
A Phase 1/2 study testing ALN Gel, BMP Gel and Mixed Gel in people with Partial Edentulism, run by University of Baghdad at 1 site in Iraq.
Trial summary
Insertion of a metal implant is considered one of the most common surgeries for fracture treatment, joint replacement, and dental implants. The success rate of these implants depends on their fixation which is in turn related primarily on the strength of the bone holding them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- ALN Gel, BMP Gel and Mixed Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jul 2019to 1 Jul 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion criteria Otherwise healthy patients over 18 years or with systemic diseases that do not interfere with bone healing Having single or multiple missing teeth in maxilla and/or mandible Having an alveolar ridge of sufficient vertical and horizontal dimensions and considered straightforward cases according to SAC classification
Exclusion criteria Patients with active or chronic infection or inflammation in the implant zone History of radiotherapy to the head and neck Past or current treatment with oral/intramuscular/intravenous bisphosphonates or other drugs altering bone metabolism Heavy smokers or with sever periodontitis
Trial locations and contacts
1 site in 1 country.
Iraq1 site
College of dentistry, University of Baghdad
Baghdad, Bab-Almoadham, 1417
About this study
Official title: Evaluation of Topical Application of Alendronate Sodium In-situ Gel and Recombinant Human Bone Morphogenic Protein 2 on Dental Implant Stability and Crestal Bone Level: A Randomized Controlled Clinical Study
Insertion of a metal implant is considered one of the most common surgeries for fracture treatment, joint replacement, and dental implants. The success rate of these implants depends on their fixation which is in turn related primarily on the strength of the bone holding them. Studies evaluating the influence of local application of antiresorptive drugs, like bisphosphonates, on implanted endoprostheses whether orthopedic or dental is increasing annually with more and more experimental studies as well as clinical trials worldwide. On the other hand implants that release medications that enhance bone formation will lead to improved implant fixation and success. The objective of this study was to evaluate the effect of topical application of alendronate sodium gel and recombinant human bone morphogenic protein 2 on dental implant stability and crestal bone level.
Read the detailed description
Bisphosphonates (BPs), which are so called because they have two phosphonate (PO3) groups, are structurally similar to natural pyrophosphate (PP), a normal product of human metabolism that has a calcium chelating property. They are used to treat bone metastases, osteoporosis, Paget's disease, and other skeletal disorders.
During bone remodeling, osteoclast bone resorptive action is impeded by BPs which are released into the resorption lacunae. These cells take up BPs from resorption lacunae and the BPs then trigger the osteoclasts to undergo apoptosis. It has been found that an adjunct treatment of implant site with BPs solution might be beneficial to initial osseointegration of immediately or delayed loaded dental implants without interfering significantly with peri-implant bone remodeling over time.
Oral or intravenous administrations are the classical BPs treatment modalities with many studies show their positive effect on peri-implant bone. More efficient delivery systems to the target sites have been investigated to minimize BPs side effects and alter their biodistribution in order to improve their bioavailability; one of those new systems is topical application. Topical application of BPs enhances osseointegration, promote implant-bone contact and increase the amount of bone peripheral to dental implants. Minimal amounts of bisphosphonates was found to improve early implant fixation and to be less prone to cause osteonecrosis of the jaw, this might lead to new possibilities for orthopedic surgery in osteoporotic bones and for dental implants with a smaller risk of such complication in comparison with systemic treatment.
In order to maximize anabolism and minimize catabolism, new coating strategies have been evolved to enhanced bone formation onto the implant surface which is more desired than only reduce bone resorption around it. So to improve implant osseointegration, a dedicated drug-loading ability to locally target bone disorders has been developed to combine antiresorptive and anabolic agents, such as bone morphogenic protein, which for instance and in osteoporotic bone, will improve bone healing process.
With a view to diminishing the side effects caused by the systemic use of BPs, such as oesophagitis and osteonecrosis of the jaw, and to maximize anabolism and minimize catabolism, recent studies have sought alternative systems for local delivery of these agents with or without bone forming agent, either by means of immobilizing on the implant surface (coating or immersion in BPs solution), or by applying the drug directly to the surgical site before implant insertion either as an irrigant or gel.
- Conditions
- Partial Edentulism
- Being tested
- ALN Gel, BMP Gel, Mixed Gel, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALN GelDrug
Also called Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599
Flapped surgery for insertion of dental implant with topical application of ALN gel
BMP GelDrug
Also called CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2
Flapped surgery for insertion of dental implant with topical application of BMP gel
Mixed GelDrug
Also called Mixture of Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599, and CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2
Flapped surgery for insertion of dental implant with topical application of mixed gel of ALN and BMP
ControlDrug
Also called No treatment
Flapped surgery for insertion of dental implant without topical application of any gel
| Study group | Role | What they receive |
|---|---|---|
| Alendronate Gel (ALN) | Active comparator | After preparation, 0.05 ml of the gel containing 100 µg of ALN will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) Receives: Drug: ALN Gel |
| Bone Morphogenic Protein Gel (BMP) | Active comparator | After preparation, 0.05 ml of the gel containing 100 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) Receives: Drug: BMP Gel |
| Mixture Gel of ALN and BMP | Active comparator | After preparation, 0.05 ml of mixture gel containing 50 µg of ALN and 50 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) Receives: Drug: Mixed Gel |
| Control | Sham comparator | After preparation, the fixture will be inserted without topical application of any medication (20 fixtures) Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Measured: 8 weeks
Implant stability
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Measured: 12 weeks post surgery
Implant stability
Mean implant stability between different comparators following implants loading by using resonance frequency analysis scaled from 1 to 100
Measured: 12 weeks post loading
Crestal bone level
Mean crestal bone level between different comparators following implants insertion by using cone beam computerized tomography measured from the first bone implant contact by millimeters
Measured: 12 weeks post surgery
Crestal bone level
Mean crestal bone level between different comparators following implants loading by using cone beam computerized tomography measured from the first bone implant contact by millimeters
Measured: 12 weeks post loading
Secondary outcomes (2)
Bone density around dental implant
Mean difference in bone density around dental implants between different comparators following implants insertion by using cone beam computerized tomography with hounsfield unit
Measured: 12 weeks post surgery
Bone density around dental implant
Mean difference in bone density around dental implants between different comparators following implants loading by using cone beam computerized tomography with hounsfield unit
Measured: 12 weeks post loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhuha A. Al-assaf, University of Baghdad
- Investigators
- Salwan Y Bede, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140006
- Sponsor's protocol ID
- 034118
- Status last verified
- Oct 2019
- First submitted
- 26 Jun 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topical Application of Alendronate Sodium In-situ Gel and Recombinant Human Bone Morphogenic Protein 2 on Dental Implant Stability and Crestal Bone Level: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04140006
- Acronym / sponsor ID
- 034118
- Conditions
- Partial Edentulism
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 25 Oct 2019 (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.
Insertion of a metal implant is considered one of the most common surgeries for fracture treatment, joint replacement, and dental implants. The success rate of these implants depends on their fixation which is in turn related primarily on the strength of the bone holding them. Studies evaluating the influence of local application of antiresorptive drugs, like bisphosphonates, on implanted endoprostheses whether orthopedic or dental is increasing annually with more and more experimental studies as well as clinical trials worldwide. On the other hand implants that release medications that enhance bone formation will lead to improved implant fixation and success. The objective of this study was to evaluate the effect of topical application of alendronate sodium gel and recombinant human bone morphogenic protein 2 on dental implant stability and crestal bone level.
Detailed description
Bisphosphonates (BPs), which are so called because they have two phosphonate (PO3) groups, are structurally similar to natural pyrophosphate (PP), a normal product of human metabolism that has a calcium chelating property. They are used to treat bone metastases, osteoporosis, Paget's disease, and other skeletal disorders.
During bone remodeling, osteoclast bone resorptive action is impeded by BPs which are released into the resorption lacunae. These cells take up BPs from resorption lacunae and the BPs then trigger the osteoclasts to undergo apoptosis. It has been found that an adjunct treatment of implant site with BPs solution might be beneficial to initial osseointegration of immediately or delayed loaded dental implants without interfering significantly with peri-implant bone remodeling over time.
Oral or intravenous administrations are the classical BPs treatment modalities with many studies show their positive effect on peri-implant bone. More efficient delivery systems to the target sites have been investigated to minimize BPs side effects and alter their biodistribution in order to improve their bioavailability; one of those new systems is topical application. Topical application of BPs enhances osseointegration, promote implant-bone contact and increase the amount of bone peripheral to dental implants. Minimal amounts of bisphosphonates was found to improve early implant fixation and to be less prone to cause osteonecrosis of the jaw, this might lead to new possibilities for orthopedic surgery in osteoporotic bones and for dental implants with a smaller risk of such complication in comparison with systemic treatment.
In order to maximize anabolism and minimize catabolism, new coating strategies have been evolved to enhanced bone formation onto the implant surface which is more desired than only reduce bone resorption around it. So to improve implant osseointegration, a dedicated drug-loading ability to locally target bone disorders has been developed to combine antiresorptive and anabolic agents, such as bone morphogenic protein, which for instance and in osteoporotic bone, will improve bone healing process.
With a view to diminishing the side effects caused by the systemic use of BPs, such as oesophagitis and osteonecrosis of the jaw, and to maximize anabolism and minimize catabolism, recent studies have sought alternative systems for local delivery of these agents with or without bone forming agent, either by means of immobilizing on the implant surface (coating or immersion in BPs solution), or by applying the drug directly to the surgical site before implant insertion either as an irrigant or gel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alendronate Gel (ALN) | Active comparator | Drug: ALN GelAfter preparation, 0.05 ml of the gel containing 100 µg of ALN will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) |
| Bone Morphogenic Protein Gel (BMP) | Active comparator | Drug: BMP GelAfter preparation, 0.05 ml of the gel containing 100 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) |
| Mixture Gel of ALN and BMP | Active comparator | Drug: Mixed GelAfter preparation, 0.05 ml of mixture gel containing 50 µg of ALN and 50 µg of BMP will be injected in the osteotomy site immediately before fixture insertion (20 fixtures) |
| Control | Sham comparator | Drug: ControlAfter preparation, the fixture will be inserted without topical application of any medication (20 fixtures) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ALN GelAlso: Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599Flapped surgery for insertion of dental implant with topical application of ALN gel | Drug | Alendronate Gel (ALN) |
| BMP GelAlso: CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2Flapped surgery for insertion of dental implant with topical application of BMP gel | Drug | Bone Morphogenic Protein Gel (BMP) |
| Mixed GelAlso: Mixture of Alendronate Sodium trihydrate, m.w 325.12, Pharmaceutical Secondary standard, PHR 1599, and CowellBMP, recombinant human bone morphogenic protein type 2, rhBMP2Flapped surgery for insertion of dental implant with topical application of mixed gel of ALN and BMP | Drug | Mixture Gel of ALN and BMP |
| ControlAlso: No treatmentFlapped surgery for insertion of dental implant without topical application of any gel | Drug | Control |
Primary outcome
Implant stability
Time frame: 8 weeks
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Implant stability
Time frame: 12 weeks post surgery
Mean implant stability between different comparators following implants insertion by using resonance frequency analysis scaled from 1 to 100
Implant stability
Time frame: 12 weeks post loading
Mean implant stability between different comparators following implants loading by using resonance frequency analysis scaled from 1 to 100
Crestal bone level
Time frame: 12 weeks post surgery
Mean crestal bone level between different comparators following implants insertion by using cone beam computerized tomography measured from the first bone implant contact by millimeters
Crestal bone level
Time frame: 12 weeks post loading
Mean crestal bone level between different comparators following implants loading by using cone beam computerized tomography measured from the first bone implant contact by millimeters
2 secondary outcomes
Bone density around dental implant
Time frame: 12 weeks post surgery
Bone density around dental implant
Time frame: 12 weeks post loading
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Salwan Y Bede 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 1/2 study testing ALN Gel, BMP Gel and Mixed Gel in people with Partial Edentulism, 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?
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 25 Oct 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 25 Oct 2019.