Implant Site ReactionNCT03665025
Immediate Implant Placement With Immediate Professionalization in Aesthetic Area
A study testing immediate implant using mixed allograft and xenograft in people with Implant Site Reaction, run by Cairo University at 1 site in Kuwait.
Trial summary
Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- immediate implant using mixed allograft and xenograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Jan 2019to 1 Jan 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 20 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, 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: Immediate Implant Placement With Immediate Professionalization in the Maxillary Esthetic Zone Using Mixture of Allograft and Xenograft vs Xenografts to Augment the Jumping Gap
Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap
Read the detailed description
Implant placement in fresh extraction sockets in conjunction with appropriate guided bone regeneration has many benefits, which ultimately affect the total treatment plan. The immediate placement of implants provides significant advantages, including fewer surgical procedures, shorter treatment time, and improved esthetics. The goals of osseous replacement are maintenance of contour, elimination of dead space, and reduce postoperative infection, provide good support for dental implant and enhance bony and soft tissue healing. allograft bone has gold standard over other augment techniques including favorable bone quality and minimal bone resorption.
- Conditions
- Implant Site Reaction
- Being tested
- immediate implant using mixed allograft and xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant using mixed allograft and xenograftOther
immediate implant using mixed allograft and xenograft in anterior area to fill jumping area
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with xenograft | Experimental | Immediate implant placement with the use of xenograft as grafting material Receives: Other: immediate implant using mixed allograft and xenograft |
| immediate implant using mixed allograft and xenograft | Experimental | Immediate implant placement with using mixture of allograft and xenograft material Receives: Other: immediate implant using mixed allograft and xenograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss
Will be measured using calliper with scale(1-10mm) for evaluation of crestal bone loss around implant which are the lower values represent a better outcome.
Measured: 1 year
Secondary outcomes (1)
Patient satisfaction
Will be measured using a satisfaction table chart which divided in 4 paraments with scale from 1-4 include( pain-infection-radiography-successful implant ),the number represent (4 excellent-3 very good -2 good-1 bad)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Site ReactionStudies 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
- Model description
- jumping gap area in aesthetic area
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammed nashmi hammad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665025
- Sponsor's protocol ID
- 14422017463550
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 12 Sep 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 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Implant Placement With Immediate Professionalization in the Maxillary Esthetic Zone Using Mixture of Allograft and Xenograft vs Xenografts to Augment the Jumping Gap
- ClinicalTrials.gov ID
- NCT03665025
- Acronym / sponsor ID
- 14422017463550
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 11 Sep 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 with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap
Detailed description
Implant placement in fresh extraction sockets in conjunction with appropriate guided bone regeneration has many benefits, which ultimately affect the total treatment plan. The immediate placement of implants provides significant advantages, including fewer surgical procedures, shorter treatment time, and improved esthetics. The goals of osseous replacement are maintenance of contour, elimination of dead space, and reduce postoperative infection, provide good support for dental implant and enhance bony and soft tissue healing. allograft bone has gold standard over other augment techniques including favorable bone quality and minimal bone resorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- jumping gap area in aesthetic area
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with xenograft | Experimental | Other: immediate implant using mixed allograft and xenograftImmediate implant placement with the use of xenograft as grafting material |
| immediate implant using mixed allograft and xenograft | Experimental | Other: immediate implant using mixed allograft and xenograftImmediate implant placement with using mixture of allograft and xenograft material |
Who may qualify
- Ages
- 20 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, 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 |
|---|---|---|
| immediate implant using mixed allograft and xenograftimmediate implant using mixed allograft and xenograft in anterior area to fill jumping area | Other | immediate implant placement with xenograft, immediate implant using mixed allograft and xenograft |
Primary outcome
Crestal bone loss
Time frame: 1 year
Will be measured using calliper with scale(1-10mm) for evaluation of crestal bone loss around implant which are the lower values represent a better outcome.
1 secondary outcome
Patient satisfaction
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant using mixed allograft and xenograft in people with Implant Site Reaction, run by Cairo University at 1 site in Kuwait.
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 12 Sep 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 Kuwait. 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 hammad, BDS (0096551553531, dr_nucler@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss (time frame: 1 year). 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 12 Sep 2018.