Bone LossNCT03112772
Socket Preservation for Dental Implant Site Development.
A study testing Puros® Allograft and CopiOs® Cancellous Particulate in people with Bone Loss, run by Imam Abdulrahman Al Faisal Hospital at 1 site in Saudi Arabia.
Trial summary
Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Puros® Allograft and CopiOs® Cancellous Particulate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Mar 2017to 20 Nov 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient > 18 years old.
- Single and or multi-rooted teeth that are non-restorable.
- Patients are keen to have implant placement at the extraction sites after 4 months of extraction.
- Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe.
- Patients are medically fit with no underlying systemic diseases.
Who cannot join
- Pregnant females.
- Smokers.
- Presence of any acute infection at the time of teeth extraction.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Immam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 31441
About this study
Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate the expected amount of horizontal and vertical alveolar bone resorption. In order to better understand which socket preservation materials might be more effective for ridge preservation and to strengthen the evidence that is relevant to the clinicians' choice of socket preservation materials, two different materials were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone xenograft covered by collagen membrane. The independent variable is the grafting material while the dependent variables are the change in socket height, and width; the ability of implant placement without the need for grafting and the success rate of implants at the time of loading.
- Conditions
- Bone Loss
- Being tested
- Puros® Allograft, CopiOs® Cancellous Particulate
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puros® AllograftOther
It is a type of bone grafting materials used for enhancing bone formation
CopiOs® Cancellous ParticulateOther
It is a type of bone grafting materials used for enhancing bone formation
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Participants who are receiving socket preservation using allograft (Puros® Allograft, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, Zimmer dental, Zimmer, USA). Receives: Other: Puros® Allograft |
| Group II | Experimental | Participants who are receiving socket preservation cancellous particulate bovine bone xenograft (CopiOs® Cancellous Particulate, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, 15x20mm, Zimmer dental, Zimmer, USA). Receives: Other: CopiOs® Cancellous Particulate |
| Group III | No intervention | No grafting materials will be inserted, so it serves as a negative control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of alveolar ridge
The distance from the buccal to the lingual surface of the alveolar ridge
Measured: 4 months
height of the alveolar ridge
The distance from the crest of the ridge to the base of the socket
Measured: 4 months
Need of further grafting at the time of implant placement
Ability to place implants
Measured: 4 months
Secondary outcomes (1)
Osseintegration of implants
Implant loss before restoration
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start20 Mar 2017
- Primary completion20 Jul 2017 (estimated)
- Study completion20 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Al Faisal Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hesham Marei, Imam Abdulrahman Al Faisal Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112772
- Sponsor's protocol ID
- 2014342
- Status last verified
- Apr 2017
- First submitted
- 8 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available after statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Preservation for Dental Implant Site Development.
- ClinicalTrials.gov ID
- NCT03112772
- Acronym / sponsor ID
- 2014342
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Al Faisal HospitalOther government
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 20 Jul 2017 (estimated)
- Study completion
- 20 Nov 2017 (estimated)
- First posted
- 13 Apr 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.
Changes in alveolar bone following teeth extraction can compromise implant placement. Socket preservation (alveolar ridge preservation) is considered as a surgical procedure employed to preserve the ridge volume within the envelope existing at the time of extraction.The ultimate aim of such procedure is to compensate the expected amount of horizontal and vertical alveolar bone resorption. In order to better understand which socket preservation materials might be more effective for ridge preservation and to strengthen the evidence that is relevant to the clinicians' choice of socket preservation materials, two different materials were compared in a randomized controlled approach. (1) Demineralized Bone Matrix (DBM) Putty and Putty with Chips allograft covered by collagen membrane, and (2) Deprotonated bovine bone xenograft covered by collagen membrane. The independent variable is the grafting material while the dependent variables are the change in socket height, and width; the ability of implant placement without the need for grafting and the success rate of implants at the time of loading.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Puros® AllograftParticipants who are receiving socket preservation using allograft (Puros® Allograft, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, Zimmer dental, Zimmer, USA). |
| Group II | Experimental | Other: CopiOs® Cancellous ParticulateParticipants who are receiving socket preservation cancellous particulate bovine bone xenograft (CopiOs® Cancellous Particulate, Zimmer dental, Zimmer, USA) covered by membrane (size: 15x20mm) made of type I collagen fibers purified from bovine tendon (BioMend® Membrane, 15x20mm, Zimmer dental, Zimmer, USA). |
| Group III | No intervention | –No grafting materials will be inserted, so it serves as a negative control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient > 18 years old.
- Single and or multi-rooted teeth that are non-restorable.
- Patients are keen to have implant placement at the extraction sites after 4 months of extraction.
- Intact buccal bone after extraction, which was confirmed by visual inspection and clinical examination using a periodontal probe.
- Patients are medically fit with no underlying systemic diseases.
Key exclusion criteria (3 listed)
- Pregnant females.
- Smokers.
- Presence of any acute infection at the time of teeth extraction.
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 |
|---|---|---|
| Puros® AllograftIt is a type of bone grafting materials used for enhancing bone formation | Other | Group I |
| CopiOs® Cancellous ParticulateIt is a type of bone grafting materials used for enhancing bone formation | Other | Group II |
Primary outcome
Width of alveolar ridge
Time frame: 4 months
The distance from the buccal to the lingual surface of the alveolar ridge
height of the alveolar ridge
Time frame: 4 months
The distance from the crest of the ridge to the base of the socket
Need of further grafting at the time of implant placement
Time frame: 4 months
Ability to place implants
1 secondary outcome
Osseintegration of implants
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: Yes. Data will be available after statistical analysis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puros® Allograft and CopiOs® Cancellous Particulate in people with Bone Loss, run by Imam Abdulrahman Al Faisal Hospital at 1 site in Saudi Arabia.
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 5 inclusion and 3 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 18 Apr 2017. 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 Saudi Arabia. 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?
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?
Width of alveolar ridge (time frame: 4 months). The study lists 3 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 18 Apr 2017.