Dental Implant FailedNCT03741036
Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone
A study testing Autogenous bone graft as space filling in immidiate implant placment, Deprotinized bovien as space filling in immidate implant placement and Nano-hydroxiapatite alloplast in immidiate implant placement in people with Dental Implant Failed, run by Mohamed tarek mohamed youssif omar at 2 sites in Egypt.
Trial summary
compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failed
- What is being tested?
- Autogenous bone graft as space filling in immidiate implant placment, Deprotinized bovien as space filling in immidate implant placement and Nano-hydroxiapatite alloplast in immidiate implant placement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 27 Nov 2018to 17 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placemen
Who cannot join
- Heavy smokers more than 20 cigarettes per day.
- 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
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University
Cairo
Mohamed tarek
Cairo
Mohamed Tarek, 00201114951862, Mtm.9mar@yahoo.com
About this study
Official title: Immediate Implant Placement With Provisionalization Using Autogenous Bone Graft Particulates vs Deproteinized Bovine Bone vs Nano-hydroxyapatite Alloplast as a Space Filling Material in the Maxillary Esthetic Zone
compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization
Read the detailed description
Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score [PES]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow-up of at least 12 months.
The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.
Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.
Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.
- Conditions
- Dental Implant Failed
- Being tested
- Autogenous bone graft as space filling in immidiate implant placment, Deprotinized bovien as space filling in immidate implant placement, Nano-hydroxiapatite alloplast in immidiate implant placement
- Keywords
- immidiate, dental implant, immidiate provisionalization, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous bone graft as space filling in immidiate implant placmentProcedure or surgery
- The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft)
- Patients will be subjected to CBCT (diagnostic for upper arch).
- Local anesthesia will be given to the patient.
- Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
- The procedure will be carried out flapless.
- In the study group: Atraumatic extraction
- The extraction socket will be evaluated for absence of any fenestration or granulation tissues
Deprotinized bovien as space filling in immidate implant placementProcedure or surgery
- The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material)
- Patients will be subjected to CBCT (diagnostic for upper arch).
- Local anesthesia will be given to the patient.
- Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
- The procedure will be carried out flapless.
- In the study group: Atraumatic extraction
- The extraction socket will be evaluated for absence of any fenestration or granulation tissues
Nano-hydroxiapatite alloplast in immidiate implant placementProcedure or surgery
- The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material )
- Patients will be subjected to CBCT (diagnostic for upper arch).
- Local anesthesia will be given to the patient.
- Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
- The procedure will be carried out flapless.
- In the study group: Atraumatic extraction
- The extraction socket will be evaluated for absence of any fenestration or granulation tissues
| Study group | Role | What they receive |
|---|---|---|
| autogenous bone graft as a space filling material | Active comparator | Autogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket Receives: Procedure: Autogenous bone graft as space filling in immidiate implant placment |
| deproteinized bovine as a space filling material | Active comparator | Granules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm. Receives: Procedure: Deprotinized bovien as space filling in immidate implant placement |
| nano-hydroxyapatite alloplast as a space filling material | Active comparator | The patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket Receives: Procedure: Nano-hydroxiapatite alloplast in immidiate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary stability (marginal bone loss)
measure device (osstell )
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start27 Nov 2018 (estimated)
- Primary completion27 Jul 2019 (estimated)
- Study completion17 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant FailedStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed tarek mohamed youssif omar
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Mohamed tarek mohamed youssif omar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741036
- Sponsor's protocol ID
- CEBD-CU-27-7-2018
- Status last verified
- Nov 2018
- First submitted
- 19 Oct 2018
- Last updated
- 19 Nov 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 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Provisionalization Using Autogenous Bone Graft Particulates vs Deproteinized Bovine Bone vs Nano-hydroxyapatite Alloplast as a Space Filling Material in the Maxillary Esthetic Zone
- ClinicalTrials.gov ID
- NCT03741036
- Acronym / sponsor ID
- CEBD-CU-27-7-2018
- Conditions
- Dental Implant Failed
- Keywords
- immidiate, dental implant, immidiate provisionalization, bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mohamed tarek mohamed youssif omarUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 27 Nov 2018 (estimated)
- Primary completion
- 27 Jul 2019 (estimated)
- Study completion
- 17 Aug 2019 (estimated)
- First posted
- 14 Nov 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.
compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization
Detailed description
Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score [PES]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow-up of at least 12 months.
The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.
Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.
Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| autogenous bone graft as a space filling material | Active comparator | Procedure: Autogenous bone graft as space filling in immidiate implant placmentAutogenous bone from sub mental bone had been grafted in jumping gap between implant and freshely extracted socket |
| deproteinized bovine as a space filling material | Active comparator | Procedure: Deprotinized bovien as space filling in immidate implant placementGranules of deproteinized bovine bone of 0.25-1.0 mm diameter were used to fill the remaining defect when the distance of the defect wall to the implant surface was > 3 mm. |
| nano-hydroxyapatite alloplast as a space filling material | Active comparator | Procedure: Nano-hydroxiapatite alloplast in immidiate implant placementThe patient was treated using alloplast material mixed with a nano-bone graft to fill gap between implant and freshely extracted socket |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
- Both sexes.
- No intraoral soft and hard tissue pathology
- No systemic condition that contraindicate implant placemen
Key exclusion criteria (4 listed)
- Heavy smokers more than 20 cigarettes per day.
- 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
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 |
|---|---|---|
| Autogenous bone graft as space filling in immidiate implant placment* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues | Procedure or surgery | autogenous bone graft as a space filling material |
| Deprotinized bovien as space filling in immidate implant placement* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues | Procedure or surgery | deproteinized bovine as a space filling material |
| Nano-hydroxiapatite alloplast in immidiate implant placement* The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material ) * Patients will be subjected to CBCT (diagnostic for upper arch). * Local anesthesia will be given to the patient. * Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures. * The procedure will be carried out flapless. * In the study group: Atraumatic extraction * The extraction socket will be evaluated for absence of any fenestration or granulation tissues | Procedure or surgery | nano-hydroxyapatite alloplast as a space filling material |
Primary outcome
Primary stability (marginal bone loss)
Time frame: 3 months
measure device (osstell )
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenous bone graft as space filling in immidiate implant placment, Deprotinized bovien as space filling in immidate implant placement and Nano-hydroxiapatite alloplast in immidiate implant placement in people with Dental Implant Failed, run by Mohamed tarek mohamed youssif omar at 2 sites 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 4 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 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact mohamed tarek, master (01114951862, mtm.omar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary stability (marginal bone loss) (time frame: 3 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 19 Nov 2018.