Ridge DeficiencyGBRNCT03290638
Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration
A study testing Guided Bone Regeneration (GBR) in people with Ridge Deficiency, run by Samer Faraj.
Trial summary
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and… Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Deficiency
- What is being tested?
- Guided Bone Regeneration (GBR)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2013to 1 Oct 2016
- 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 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients included in the study were required:
- Not to be completely edentulous.
- To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned
Who cannot join
- Had received radiation therapy
- Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
- Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
- Were smokers (more than 10 cigarettes per day)
- Were pregnant or breastfeeding.
About this study
Official title: Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Read the detailed description
Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.
- Conditions
- Ridge Deficiency
- Being tested
- Guided Bone Regeneration (GBR)
- Keywords
- Guided Bone Regeneration, Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane, Ridge Preservation, Ridge Healing, Teeth Extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Bone Regeneration (GBR)Procedure or surgery
Also called Ridge Preservation
Teeth Extraction With Bone Grafting and Membrane
| Study group | Role | What they receive |
|---|---|---|
| Dehydrated Human Amnion Chorion Membrane | Experimental | This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement. Receives: Procedure: Guided Bone Regeneration (GBR) |
| Type I Bovine Collagen Membrane | Active comparator | This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement. Receives: Procedure: Guided Bone Regeneration (GBR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Ridge Dimensional Changes
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Measured: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
Alveolar Ridge Bone Vitality
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
Measured: Mean= 19.5 weeks after tooth extraction and bone grafting
Secondary outcomes (1)
Ridge Healing Evaluation
Pictures of the healing ridges were taken using clinical macro lens photography
Measured: Two weeks form the time of the extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start3 Oct 2013
- Primary completion1 Oct 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge DeficiencyStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samer Faraj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samer Faraj, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290638
- Sponsor's protocol ID
- 13-0540-F3R
- Acronym
- GBR
- Status last verified
- Sep 2017
- First submitted
- 6 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dehydrated Human Amnion-Chorion and Type 1 Bovine Collagen Membranes for Guided Bone Regeneration (Socket Augmentation) : A Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT03290638
- Acronym / sponsor ID
- GBR / 13-0540-F3R
- Conditions
- Ridge Deficiency
- Keywords
- Guided Bone Regeneration, Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane, Ridge Preservation, Ridge Healing, Teeth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Samer FarajUniversity, hospital or other
- Study start
- 3 Oct 2013 (actual)
- Primary completion
- 1 Oct 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 25 Sep 2017 (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.
The objective of this randomized clinical study was to evaluate the use of dehydrated human amnion-chorion membrane as an exposed barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement.
Detailed description
Forty-three patients requiring extraction of at least one tooth and delayed implant placement were randomly assigned to either an experimental or a control group. For both groups, demineralized freeze-dried bone allograft was used to graft the socket. For the control group, Type I bovine collagen was used as a membrane; for the experimental group, human amnion-chorion membrane was used. For both groups, the barrier membranes were left exposed, and no primary closure was achieved. Patients returned for implant placement after a mean healing period of 19.5 weeks, at which time a core bone biopsy specimen 2 mm in diameter was obtained for histomorphometric analyses. Clinical ridge dimensions were measured at the times of extraction and implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dehydrated Human Amnion Chorion Membrane | Experimental | Procedure: Guided Bone Regeneration (GBR)This membrane was investigated to evaluate its use as an open barrier for guided bone regeneration (GBR) after tooth extraction and to determine whether intentional exposure of this membrane to the oral environment compromises ridge dimensions and bone vitality for implant placement. |
| Type I Bovine Collagen Membrane | Active comparator | Procedure: Guided Bone Regeneration (GBR)This membrane has been tested as an open barrier for GBR after tooth extraction. The intentional use of this membrane to the oral environment did not compromise ridge dimensions and bone vitality for implant placement. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not to be completely edentulous.
- To have at least 1 tooth that could not be saved and for which extraction and delayed implant placement were planned
Key exclusion criteria (5 listed)
- Had received radiation therapy
- Were taking antiresorptive medication (i.e., bisphosphonate or denosumab)
- Had uncontrolled systemic disorders (such as uncontrolled diabetes, congestive heart failure, or acute odontogenic infections)
- Were smokers (more than 10 cigarettes per day)
- Were pregnant or breastfeeding.
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 |
|---|---|---|
| Guided Bone Regeneration (GBR)Also: Ridge PreservationTeeth Extraction With Bone Grafting and Membrane | Procedure or surgery | Dehydrated Human Amnion Chorion Membrane, Type I Bovine Collagen Membrane |
Primary outcome
Alveolar Ridge Dimensional Changes
Time frame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks
Clinical ridge height changes were taken with a thermoplastic triad stent, and a University of North Carolina (UNC) 15 periodontal probe. Ridge width changes measurements were taken with a metal bone caliper. Alveolar ridge dimensional changes in height and width were measured at the times of extraction and at the time of implant placement.
Alveolar Ridge Bone Vitality
Time frame: Mean= 19.5 weeks after tooth extraction and bone grafting
a core bone biopsy specimen 2 mm in diameter was obtained from the center of the root at the time of implant placement for histomorphometric analyses
1 secondary outcome
Ridge Healing Evaluation
Time frame: Two weeks form the time of the extraction
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 25 Sep 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Bone Regeneration (GBR) in people with Ridge Deficiency, run by Samer Faraj.
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 3 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 25 Sep 2017. 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?
Alveolar Ridge Dimensional Changes (time frame: Alveolar Ridge Dimensional Changes were taken at the extraction time and at the time of implant placement. Mean = 19.5 weeks). The study lists 2 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 Sep 2017.