Bone LossNCT03397316
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Esthetic Zone Without Xenograft.
A study testing xenograft placement . in people with Bone Loss, run by Cairo University at 1 site in Egypt.
Trial summary
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side. the study is to assess the marginal bone loss in the two techniques and compare results between them. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- xenograft placement .
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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 root apex
Who cannot join
- presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases that may affect normal healing. psychiatric problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
info@dentistry.cu.edu.eg info@dentistry.cu.edu.eg, 0023634965, info@dentistry.cu.edu.eg
Ahmed Alaa
About this study
Official title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With and Without Xenograft.
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them.
Read the detailed description
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them after follow up period of 4 months.
- Conditions
- Bone Loss
- Being tested
- xenograft placement .
- Keywords
- immediate implant, upper esthetic zone, marginal bone loss
- 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.
xenograft placement .Procedure or surgery
immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface.
| Study group | Role | What they receive |
|---|---|---|
| Marginal bone loss without grafting. | No intervention | immediate implant placement in upper esthetic zone. |
| marginal bone loss with xenograft. | Active comparator | xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface. Receives: Procedure: xenograft placement . |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft
Measured: 4 months
Secondary outcomes (1)
patient satisfaction
measure patient satisfaction by patient satisfaction chart.
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 posted12 Jan 2018
- Study start1 Jul 2017
- Primary completion15 Mar 2018 (estimated)
- Study completion1 Apr 2018 (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.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Alaa Eldin Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397316
- Sponsor's protocol ID
- AlaaCUImplant
- Status last verified
- Jan 2018
- First submitted
- 1 Jan 2018
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. 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 and Without Xenograft.
- ClinicalTrials.gov ID
- NCT03397316
- Acronym / sponsor ID
- AlaaCUImplant
- Conditions
- Bone Loss
- Keywords
- immediate implant, upper esthetic zone, marginal bone loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 12 Jan 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.
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them.
Detailed description
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them after follow up period of 4 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Marginal bone loss without grafting. | No intervention | –immediate implant placement in upper esthetic zone. |
| marginal bone loss with xenograft. | Active comparator | Procedure: xenograft placement .xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction presence of at least 4 mm of bone beyond root apex
Key exclusion criteria (1 listed)
- presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases 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 |
|---|---|---|
| xenograft placement .immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface. | Procedure or surgery | marginal bone loss with xenograft. |
Primary outcome
marginal bone loss
Time frame: 4 months
Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft
1 secondary outcome
patient satisfaction
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 17 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing xenograft placement . in people with Bone Loss, 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 1 inclusion and 1 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 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone loss (time frame: 4 months). 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 Jan 2018.