Implant Placement in Maxillary Esthetic ZoneNCT03536260
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft
A study testing Implant with NanoBone graft and Implant with Xenograft in people with Implant Placement in Maxillary Esthetic Zone, run by Cairo University at 1 site in Egypt.
Trial summary
Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implant Placement in Maxillary Esthetic Zone
- What is being tested?
- Implant with NanoBone graft and Implant with Xenograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Jun 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
- No healthy volunteers
- 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 the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- 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 history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft (Randomized Clinical Trial)
Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction.
After immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.
- Being tested
- Implant with NanoBone graft, Implant with Xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant with NanoBone graftDevice
Using of NanoBone graft to fill the gap in the socket after immediate implant placement
Implant with XenograftDevice
Using of Xenograft to fill the gap in the socket after immediate implant placement
| Study group | Role | What they receive |
|---|---|---|
| Immediate implant with Xenograft | Active comparator | Not described Receives: Device: Implant with Xenograft |
| Immediate implant with Nanobone | Active comparator | Not described Receives: Device: Implant with NanoBone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Crestal Bone Loss in grafted socket
Measured: 3 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start1 Jul 2017
- Primary completion30 May 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Placement in Maxillary Esthetic ZoneStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Mohammed Farahat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03536260
- Sponsor's protocol ID
- FarahatMBL
- Status last verified
- May 2018
- First submitted
- 5 Apr 2018
- Last updated
- 24 May 2018
- Results posted
- 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 24 May 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 Nanobone Versus Xenograft (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03536260
- Acronym / sponsor ID
- FarahatMBL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 24 May 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.
Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction.
After immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.
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 |
|---|---|---|
| Immediate implant with Xenograft | Active comparator | Device: Implant with Xenograft |
| Immediate implant with Nanobone | Active comparator | Device: Implant with NanoBone graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Key exclusion criteria (5 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 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 |
|---|---|---|
| Implant with NanoBone graftUsing of NanoBone graft to fill the gap in the socket after immediate implant placement | Device | Immediate implant with Nanobone |
| Implant with XenograftUsing of Xenograft to fill the gap in the socket after immediate implant placement | Device | Immediate implant with Xenograft |
Primary outcome
Measurement of Crestal Bone Loss in grafted socket
Time frame: 3 months after implant placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 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.
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 Implant with NanoBone graft and Implant with Xenograft in people with Implant Placement in Maxillary Esthetic Zone, 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 4 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: status not confirmed, as of the sponsor's last update on 24 May 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?
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?
Measurement of Crestal Bone Loss in grafted socket (time frame: 3 months after implant placement). 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 24 May 2018.