Badly Broken Maxillary Premolars Indicated for ExtractionNCT03716323
Immediate Implants in Maxillary Premolar Region Using Xenograft vs Allograft
A study testing immediate premolar implant with xenograft and allograft in people with Badly Broken Maxillary Premolars Indicated for Extraction, run by Cairo University.
Trial summary
Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Badly Broken Maxillary Premolars Indicated for Extraction
- What is being tested?
- immediate premolar implant with xenograft and allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Nov 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Who cannot join
- Presence of fenestrations or dehiscence of the residual bony walls after extraction.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Premolar Zone With Allograft Versus Xenograft
Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.
Read the detailed description
Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.
- Being tested
- immediate premolar implant with xenograft and allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate premolar implant with xenograft and allograftDevice
- A peritome will be used for atraumatic extraction of remaining roots.
- The extraction socket will be evaluated for absence of any fenestration or granulation tissues.
- Copious normal saline irrigation and curettage will be performed.
- In the study group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with cortico-cancellous allograft (MinerOss®, BioHorizons, USA)
- In the control group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with anorganic bovine bone mineral xenograft (Bio-Oss®, Geistlich, USA)
| Study group | Role | What they receive |
|---|---|---|
| immediate premolar implant with xenograft and allograft | Experimental | Immediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft Receives: Device: immediate premolar implant with xenograft and allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss
The amount of marginal bone loss will be measured using cone beam computed tomography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Broken Maxillary Premolars Indicated for ExtractionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Abdallah AbdelFattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716323
- Sponsor's protocol ID
- CairoMOImplant
- Status last verified
- Oct 2018
- First submitted
- 21 Oct 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Premolar Zone With Allograft Versus Xenograft
- ClinicalTrials.gov ID
- NCT03716323
- Acronym / sponsor ID
- CairoMOImplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 23 Oct 2018 (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.
Immediate implant placement has the disadvantage of difficulty in obtaining primary stability, lack of adequate soft tissue coverage and also the control of the implant position is difficult in addition to the cost of the graft. Autogenous bone graft is considered to be the golden standard for grafting as it has osteoconductive , osteoinductive and osteogenic functions , however it has the problems of donor site morbidity , the need for two surgeries as well as post operative swelling and discomfort of the patient , so alternative bone grafts as allografts and xenografts, has been introduced.
Detailed description
Allograft bone is obtained from individuals of the same species, derived from human-cadaver bone that has been selected and tested to be free of HIV and transmitted diseases. The most common allograft used is dematerialized freeze-dried bone allograft (DFDBA), provide type I collagen, which comprises most of the organic component of bone. In addition, allograft contains BMPs, which stimulate osteoinduction. There are thirteen proteins have been identified (BMP1-BMP13) which are osteoinductive compounds and stimulate new bone formation. A previous study demonstrated that, a combination of osseous coagulum collected during preparation and freeze-dried bone allograft placed at immediate implant insertion and loading. Xenografts are one of the most successful and widely used grafting materials nowadays as a replacement for autogenous bone grafts. Studies showed that xenografts are very successful because of their osteoconductive properties, their denisty which provides stabilization to the graft and implant and they supply the necessary minerals for bone formation as xenograft don't resorb completely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate premolar implant with xenograft and allograft | Experimental | Device: immediate premolar implant with xenograft and allograftImmediate Implant Placement in Maxillary Premolar zone with grafting the jumping gap using xenograft and allograft |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients with badly broken teeth in upper premolar zone indicated for extraction, presence of at least 3 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (5 listed)
- Presence of fenestrations or dehiscence of the residual bony walls after extraction.
- Heavy smokers more than 20 cigarettes per day.
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to 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 |
|---|---|---|
| immediate premolar implant with xenograft and allograft* A peritome will be used for atraumatic extraction of remaining roots. * The extraction socket will be evaluated for absence of any fenestration or granulation tissues. * Copious normal saline irrigation and curettage will be performed. * In the study group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with cortico-cancellous allograft (MinerOss®, BioHorizons, USA) * In the control group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with anorganic bovine bone mineral xenograft (Bio-Oss®, Geistlich, USA) | Device | immediate premolar implant with xenograft and allograft |
Primary outcome
Marginal Bone Loss
Time frame: 6 months
The amount of marginal bone loss will be measured using cone beam computed tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing immediate premolar implant with xenograft and allograft in people with Badly Broken Maxillary Premolars Indicated for Extraction, run by Cairo University.
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 5 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 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ahmed M Abdallah, BDS (+201272702226, ahmed.m.abdallah@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Marginal Bone Loss (time frame: 6 months). 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 23 Oct 2018.