Bone ResorptionNCT03584984
Autogenous Bone Mixed With Xenograft Versus Xenograft Alone Versus Absorbent Gelatin Sponge
A study testing Mixture of Autogenous bone & Anorganic Bovine Bone (ABB), Anorganic Bovine Bone (ABB) and Absorbable gelatin sponge in people with Bone Resorption and Alveolar Bone Loss, run by Cairo University.
Trial summary
Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption, Alveolar Bone Loss, Alveolar Bone Resorption
- What is being tested?
- Mixture of Autogenous bone & Anorganic Bovine Bone (ABB), Anorganic Bovine Bone (ABB) and Absorbable gelatin sponge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Jul 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
- 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
- Disorders to implant are related to a history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
- Patients that refuse to be called back for implant placement post extraction.
- Patients that have exceeded bone resorption surrounding the tooth prior to extraction and require guided bone regeneration.
- Pregnant Females.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement
- Being tested
- Mixture of Autogenous bone & Anorganic Bovine Bone (ABB), Anorganic Bovine Bone (ABB), Absorbable gelatin sponge
- Medical subject headings
- Bone Resorption, Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)Procedure or surgery
Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
Anorganic Bovine Bone (ABB)Procedure or surgery
Filling the socket with Anorganic bovine bone graft material only
Absorbable gelatin spongeProcedure or surgery
Filling the socket with an absorbable gelatin sponge foam pack
| Study group | Role | What they receive |
|---|---|---|
| Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) | Experimental | socket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone Receives: Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) |
| Anorganic bovine bone graft (ABB) | Active comparator | filling the extraction socket with ABB graft Receives: Procedure: Anorganic Bovine Bone (ABB) |
| Absorbable gelatin Sponge | Active comparator | Filling the socket with an absorbable gelatin sponge Receives: Procedure: Absorbable gelatin sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometrical bone analysis
histological bone core analysis
Measured: 6 month post primary surgery
Secondary outcomes (1)
Alveolar Bone marginal loss
CBCT measurements of marginal bone dimensional difference
Measured: 6 month post primary surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohammed Al-esawy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584984
- Sponsor's protocol ID
- 2807
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 17 Jul 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 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation in Mandibular Molars Using Mixture of Autogenous Bone & Anorganic Bovine Bone (ABB) Versus Anorganic Bovine Bone Alone Versus Absorbent Gelatin Sponge
- ClinicalTrials.gov ID
- NCT03584984
- Acronym / sponsor ID
- 2807
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jul 2019 (estimated)
- First posted
- 12 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.
Alveolar bone atrophy post-extraction has been well documented in the past years. normal healing event results in a minimal loss of vertical height (around 1 mm), but a substantial loss of width in the buccal-lingual plane (4-6 mm). Alveolar socket preservation is thought to deal with this issue as to prevent the loss of alveolar bone dimensions post extraction in the case of delayed implant placement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) | Experimental | Procedure: Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)socket preservation with a mixture of autogenous bone graft acquired at the time of extraction mixed with a 50:50 ratio of Anorganic bovine bone |
| Anorganic bovine bone graft (ABB) | Active comparator | Procedure: Anorganic Bovine Bone (ABB)filling the extraction socket with ABB graft |
| Absorbable gelatin Sponge | Active comparator | Procedure: Absorbable gelatin spongeFilling the socket with an absorbable gelatin sponge |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients with hopeless mandibular molars indicated for extraction and implant placement in two stages that indicate socket preservation.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (8 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
- Disorders to implant are related to a 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 |
|---|---|---|
| Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio | Procedure or surgery | Mixture of Autogenous bone & Anorganic Bovine Bone (ABB) |
| Anorganic Bovine Bone (ABB)Filling the socket with Anorganic bovine bone graft material only | Procedure or surgery | Anorganic bovine bone graft (ABB) |
| Absorbable gelatin spongeFilling the socket with an absorbable gelatin sponge foam pack | Procedure or surgery | Absorbable gelatin Sponge |
Primary outcome
Histomorphometrical bone analysis
Time frame: 6 month post primary surgery
histological bone core analysis
1 secondary outcome
Alveolar Bone marginal loss
Time frame: 6 month post primary surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 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 Mixture of Autogenous bone & Anorganic Bovine Bone (ABB), Anorganic Bovine Bone (ABB) and Absorbable gelatin sponge in people with Bone Resorption and Alveolar Bone Loss, 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 8 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 17 Jul 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 Dina M. Al-Esawy, Masters (01206036365, dr.dina.alesawy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histomorphometrical bone analysis (time frame: 6 month post primary surgery). 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 17 Jul 2018.