Badly Decayed Anterior Maxillary TeethNCT03607864
Coral Bone Graft Verses Xenograft With Immediate Implant in Maxillary Anterior Esthetic Zone
A study testing coral bone graft and xenograft in people with Badly Decayed Anterior Maxillary Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Badly Decayed Anterior Maxillary Teeth
- What is being tested?
- coral bone graft and xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2019to 10 Jun 2020
- 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 esthetic zone indicated for extraction, presence of at least 4 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 .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Coral Bone Versus Xenograft
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 alloplast has been introduced.
Coral bone has a structure which is similar to that of cancellous bone , its mechanical properties is similar to that of bone and it consists of high content of calcium carbonate scaffolds that has the advantages of being biodegradable , biocompatible and osteoconductive , they act as a carrier for growth factors and allow cell attachment , growth , spreading , differentiation and has been found to be effective bone graft
Read the detailed description
Immediate implant placement has the advantages of better esthetics , reduction in the number of surgeries (one surgery is needed) and reduction in the time of treatment so it is more suitable and comfortable for patients .
Immediate implant placement in fresh extraction socket after tooth extraction may reduce the incidence of bone loss compared to implant placement in the healed bone.
Certain studies showed that bone resorption occurs with immediate implant placement and there is high risk of failure and complications.
The gold standard for immediate implant placement is placing bone graft around the implant to fill the jumping gap between the implant and the socket.
Certain studies showed that if the jumping gap is 1-2 mm so no grafting is needed , but if the gap is more than 2mm then bone grafting is needed .
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.
Despite these disadvantages the success rates of immediate implants is very high.
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 alloplast has been introduced.
Coral bone has a structure which is similar to that of cancellous bone , its mechanical properties is similar to that of bone and it consists of high content of calcium carbonate scaffolds that has the advantages of being biodegradable , biocompatible and osteoconductive , they act as a carrier for growth factors and allow cell attachment , growth , spreading , differentiation and has been found to be effective bone graft.
Certain studies showed that coral bone has similar results as autogenous bone and that it is encouraging for the osteoregenerative process resulting in tissue organization that allows for mechanical stability and function which is similar to that of native bone.
6b. Choice of the comparator: 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.
Xenografts undergoes deprotienaization by heating to eliminate the allergic reactions and risk of disease transmission .
The survival rate of implants with the use of xenografts as grating material is the same as implants using autogenous bone grafts .
Xenografts has the disadvantages of that there is a risk of cross contamination and possible development of immune reaction as there is no way to adequately screen them .
- Conditions
- Badly Decayed Anterior Maxillary Teeth
- Being tested
- coral bone graft and xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coral bone graft and xenograftDevice
ligible patients will be randomized in equal proportions between control group(immediate implant placement with grafting with xenograft) and study group (immediate implant placement with grafting with coral bone) Patients of both groups will be subjected to standard panoramic radiographs, cone beam ct .
Crestal bone level will measured by cone beam ct. Local anesthesia will be given to the patient. Only sulcular incision line with reflection is used A peritome will be used for a traumatic extraction of remaining roots. The extraction socket will be evaluated for absence of any fenestration or granulation tissues implant will be inserted in extraction socket bodily palatal with grafting with coral bone and xenograft The flap will then be copiously irrigated with saline in preparation for closure.
The flap will then be closed using interrupted 5/0 prolene sutures.
| Study group | Role | What they receive |
|---|---|---|
| coral bone graft and xenograft | Experimental | Extraction of upper anterior badly broken teeth with immediate implant placement with the use of coral bone and xenograft as grafting material between the implant and the labial socket bone Receives: Device: coral bone graft and xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
crestal bone loss
the amount of crestal bone loss will be measured using cone beam computed tomography
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start10 Jun 2019
- Primary completion10 Jun 2020
- Study completion10 Jun 2020
Why it stopped: because bone osteointegration is completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Badly Decayed Anterior Maxillary TeethStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amro Abdelaal Abdelhakim Elbahkiri, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607864
- Sponsor's protocol ID
- CairoUimplant
- Status last verified
- Jul 2020
- First submitted
- 20 Jun 2018
- Last updated
- 21 Jul 2020
- 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 21 Jul 2020. 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 Esthetic Zone With Coral Bone Versus Xenograft
- ClinicalTrials.gov ID
- NCT03607864
- Acronym / sponsor ID
- CairoUimplant
- Conditions
- Badly Decayed Anterior Maxillary Teeth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because bone osteointegration is completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Jun 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 31 Jul 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.
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 alloplast has been introduced.
Coral bone has a structure which is similar to that of cancellous bone , its mechanical properties is similar to that of bone and it consists of high content of calcium carbonate scaffolds that has the advantages of being biodegradable , biocompatible and osteoconductive , they act as a carrier for growth factors and allow cell attachment , growth , spreading , differentiation and has been found to be effective bone graft
Detailed description
Immediate implant placement has the advantages of better esthetics , reduction in the number of surgeries (one surgery is needed) and reduction in the time of treatment so it is more suitable and comfortable for patients .
Immediate implant placement in fresh extraction socket after tooth extraction may reduce the incidence of bone loss compared to implant placement in the healed bone.
Certain studies showed that bone resorption occurs with immediate implant placement and there is high risk of failure and complications.
The gold standard for immediate implant placement is placing bone graft around the implant to fill the jumping gap between the implant and the socket.
Certain studies showed that if the jumping gap is 1-2 mm so no grafting is needed , but if the gap is more than 2mm then bone grafting is needed .
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.
Despite these disadvantages the success rates of immediate implants is very high.
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 alloplast has been introduced.
Coral bone has a structure which is similar to that of cancellous bone , its mechanical properties is similar to that of bone and it consists of high content of calcium carbonate scaffolds that has the advantages of being biodegradable , biocompatible and osteoconductive , they act as a carrier for growth factors and allow cell attachment , growth , spreading , differentiation and has been found to be effective bone graft.
Certain studies showed that coral bone has similar results as autogenous bone and that it is encouraging for the osteoregenerative process resulting in tissue organization that allows for mechanical stability and function which is similar to that of native bone.
6b. Choice of the comparator: 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.
Xenografts undergoes deprotienaization by heating to eliminate the allergic reactions and risk of disease transmission .
The survival rate of implants with the use of xenografts as grating material is the same as implants using autogenous bone grafts .
Xenografts has the disadvantages of that there is a risk of cross contamination and possible development of immune reaction as there is no way to adequately screen them .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coral bone graft and xenograft | Experimental | Device: coral bone graft and xenograftExtraction of upper anterior badly broken teeth with immediate implant placement with the use of coral bone and xenograft as grafting material between the implant and the labial socket bone |
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 esthetic zone indicated for extraction, presence of at least 4 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 (4 listed)
- Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
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 |
|---|---|---|
| coral bone graft and xenograftligible patients will be randomized in equal proportions between control group(immediate implant placement with grafting with xenograft) and study group (immediate implant placement with grafting with coral bone) Patients of both groups will be subjected to standard panoramic radiographs, cone beam ct . Crestal bone level will measured by cone beam ct. Local anesthesia will be given to the patient. Only sulcular incision line with reflection is used A peritome will be used for a traumatic extraction of remaining roots. The extraction socket will be evaluated for absence of any fenestration or granulation tissues implant will be inserted in extraction socket bodily palatal with grafting with coral bone and xenograft The flap will then be copiously irrigated with saline in preparation for closure. The flap will then be closed using interrupted 5/0 prolene sutures. | Device | coral bone graft and xenograft |
Primary outcome
crestal bone loss
Time frame: 4 month
the amount of crestal bone loss will be measured using cone beam computed tomography
Results and safety
The study was stopped early (reason given: because bone osteointegration is completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coral bone graft and xenograft in people with Badly Decayed Anterior Maxillary Teeth, run by Cairo University at 1 site in Egypt.
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 4 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: stopped early, as of the sponsor's last update on 21 Jul 2020. 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 Egypt. 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.
Are results available for this study?
The study was stopped early (reason given: because bone osteointegration is completed). 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?
crestal bone loss (time frame: 4 month). 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 21 Jul 2020.