Alveolar Ridge PreservationNCT04321109
Alveolar Ridge Preservation Using Collagen Material and Allograft
A study testing Allograft and Collagen cone in people with Alveolar Ridge Preservation, run by Yasmine Fouad.
Trial summary
Seven Patients who need implants to replace non-restorable teeth in the esthetic zone. Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Allograft and Collagen cone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2016to 21 Mar 2018
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients were medically free .
- Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment.
Who cannot join
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Pregnant and breast-feeding females.
- Smokers , Teeth with periodontal or periapical infections.
- Patients with malocclusion.
- All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)
About this study
Official title: Alveolar Ridge Preservation Using Collagen Material and Allograft: A Randomized Controlled Trial
Seven Patients who need implants to replace non-restorable teeth in the esthetic zone.
Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation.
Read more
Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation.
Outcome
- Alveolar ridge preservation both in height and in width to improve implant success rate
- The height of alveolar ridge was assessed clinically using a periodontal probe.
- The width of the alveolar ridge was measured after three months after extraction using a caliper clamp.
- Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT). 2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis. 3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation
Read the detailed description
The aim of the present study was to compare three months post-extraction augmented ridge using collagen matrix versus mineralized cortico-cancellous bone allograft. This comparison was done clinically, histologically, immunohisto-chemically and radiologically.
- Clinical parameters included; vertical bone height and bone width that were recorded at baseline and at three months after extraction. Moreover, histomorphometric parameters included; area fraction of osteoid and mature bone three months after extraction by histomorphometric analysis. Immunohistochemical analysis using polyclonal antibody to detect BMP-2 marker of bone formation. Radiographic parameters included superimposition of baseline CBCT, three months after extraction and another one six months after loading with subsequent measurement of bone height, bone width and bone density.
A core biopsy was taken three months after tooth extraction which has undergone histomorphometric and immunohistochemical analysis; implant placement was also done at the same time.
In the present study, it was found that the mean bone height decreased with a higher percent in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between both groups.
In addition, this study showed that the mean bone width decreased more in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between them.
Moreover, in the present study, Histomorphometric analysis revealed new bone trabeculae formation with osteoblastic rimming, the surrounding fibrous tissue is cellular and remnants of the graft materials was detected , with no marked difference in the amount of newly formed bone between two groups .
Regarding immunohistochemical analysis in both groups, the osteoblasts in the fibrous tissue and osteocytes in newly formed bone are showing nuclear staining, with increasing area of immunopositive cells in mineralized cortico-cancellous bone allograft group.
Radiographically, CBCT superimposition revealed that a greater percent decrease in bone height was denoted in collagen matrix than mineralized cortico-cancellous bone allograft group with a significant difference between both groups after 3 and 6 months.
Accordingly bone width showed a higher decrease in mineralized cortico-cancellous bone allograft group than Collagen matrix group with a non significant difference between both groups after 3 and 6 months.
Finally, bone density showed a greater decrease in Collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference after 3 months but significant difference was found after 6 months between both groups.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Allograft, Collagen cone
- Keywords
- Alveolar ridge preservation, Allograft, Collagen cone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllograftOther
Corticocancellous mineralized allograft
Collagen coneOther
Collagen matrix
| Study group | Role | What they receive |
|---|---|---|
| Collagen cone | Experimental | Collagen matrix Receives: Other: Collagen cone |
| Allograft | Active comparator | mineralized corticocancellous allograft Receives: Other: Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical score
Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically
Measured: change from baseline at 12 weeks
Secondary outcomes (1)
BMP-2
Bone morphogenic protein -2 immunopositive cells in immunostained sections
Measured: detected at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start2 Jun 2016
- Primary completion21 Mar 2018
- Study completion21 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge PreservationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group (1): Seven extraction sockets that received the collagen matrix (Collacone) for alveolar ridge preservation. Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft (Maxgraft) for alveolar ridge preservation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yasmine Fouad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yasmine Fouad, Ain Shams University
- Investigators
- Hala A Abuel-Ela, Professor, Study director, Faculty of Dentistry Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321109
- Sponsor's protocol ID
- FDASU-RECD 071402
- Status last verified
- Sep 2022
- First submitted
- 22 Mar 2020
- Last updated
- 23 Sep 2022
- 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 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation Using Collagen Material and Allograft: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04321109
- Acronym / sponsor ID
- FDASU-RECD 071402
- Conditions
- Alveolar Ridge Preservation
- Keywords
- Alveolar ridge preservation, Allograft, Collagen cone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Yasmine FouadUniversity, hospital or other
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 21 Mar 2018 (actual)
- Study completion
- 21 Mar 2018 (actual)
- First posted
- 25 Mar 2020 (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.
Seven Patients who need implants to replace non-restorable teeth in the esthetic zone.
Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation.
Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation.
Outcome
- Alveolar ridge preservation both in height and in width to improve implant success rate
- The height of alveolar ridge was assessed clinically using a periodontal probe.
- The width of the alveolar ridge was measured after three months after extraction using a caliper clamp.
- Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT). 2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis. 3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation
Detailed description
The aim of the present study was to compare three months post-extraction augmented ridge using collagen matrix versus mineralized cortico-cancellous bone allograft. This comparison was done clinically, histologically, immunohisto-chemically and radiologically.
- Clinical parameters included; vertical bone height and bone width that were recorded at baseline and at three months after extraction. Moreover, histomorphometric parameters included; area fraction of osteoid and mature bone three months after extraction by histomorphometric analysis. Immunohistochemical analysis using polyclonal antibody to detect BMP-2 marker of bone formation. Radiographic parameters included superimposition of baseline CBCT, three months after extraction and another one six months after loading with subsequent measurement of bone height, bone width and bone density.
A core biopsy was taken three months after tooth extraction which has undergone histomorphometric and immunohistochemical analysis; implant placement was also done at the same time.
In the present study, it was found that the mean bone height decreased with a higher percent in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between both groups.
In addition, this study showed that the mean bone width decreased more in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between them.
Moreover, in the present study, Histomorphometric analysis revealed new bone trabeculae formation with osteoblastic rimming, the surrounding fibrous tissue is cellular and remnants of the graft materials was detected , with no marked difference in the amount of newly formed bone between two groups .
Regarding immunohistochemical analysis in both groups, the osteoblasts in the fibrous tissue and osteocytes in newly formed bone are showing nuclear staining, with increasing area of immunopositive cells in mineralized cortico-cancellous bone allograft group.
Radiographically, CBCT superimposition revealed that a greater percent decrease in bone height was denoted in collagen matrix than mineralized cortico-cancellous bone allograft group with a significant difference between both groups after 3 and 6 months.
Accordingly bone width showed a higher decrease in mineralized cortico-cancellous bone allograft group than Collagen matrix group with a non significant difference between both groups after 3 and 6 months.
Finally, bone density showed a greater decrease in Collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference after 3 months but significant difference was found after 6 months between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group (1): Seven extraction sockets that received the collagen matrix (Collacone) for alveolar ridge preservation. Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft (Maxgraft) for alveolar ridge preservation
| Arm | Type | Receives |
|---|---|---|
| Collagen cone | Experimental | Other: Collagen coneCollagen matrix |
| Allograft | Active comparator | Other: Allograftmineralized corticocancellous allograft |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients were medically free .
- Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment.
Key exclusion criteria (5 listed)
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Pregnant and breast-feeding females.
- Smokers , Teeth with periodontal or periapical infections.
- Patients with malocclusion.
- All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)
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 |
|---|---|---|
| AllograftCorticocancellous mineralized allograft | Other | Allograft |
| Collagen coneCollagen matrix | Other | Collagen cone |
Primary outcome
clinical score
Time frame: change from baseline at 12 weeks
Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically
1 secondary outcome
BMP-2
Time frame: detected at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
Hala A Abuel-Ela, Professor study director
Faculty of Dentistry Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing Allograft and Collagen cone in people with Alveolar Ridge Preservation, run by Yasmine Fouad.
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 2 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: finished, as of the sponsor's last update on 23 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical score (time frame: change from baseline at 12 weeks). 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 Sep 2022.