Maintain the EstheticNCT05006014
Immediate Implant With Provisionalization
An observational study of Maintain the Esthetic, run by University of Baghdad at 1 site in Iraq.
Trial summary
Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maintain the Esthetic
- What is being tested?
- Tooth guided immediate implant placement
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteIraq
- Study dates
- 27 Jan 2021to 27 Mar 2022
- How long will I take part?
- 4 Months
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult with non restorable dental unit seeking for immediate implantation with provisionalization
Who may be able to join
- Medical and psychological fitness for minor oral surgery.
- Age 20-60 years.
- medium to thick gingival biotype.
- buccal plate thickness more than (1mm).
Who cannot join
- Smoking habit.
- Diabetes mellitus.
- A systemic disorder that is contraindicated for the minor surgical procedure.
- Pregnancy or lactation.
- Any irradiation in head and neck area.
- Need for bone augmentation procedure.
- Clinical signs of bruxism or other severe functional disorders.
- patient with periodontal disease.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of dentistry
Baghdad, Bab Al Moatham, 11001
Dalya M Naeem, B.D.S, 07705653307 ext. +964, dahlia93m@gmail.com
Hassanien A Hadi, B.D.S, C.A.B.M.S, 07708896181 ext. +964, hassanien_dent@yahoo.com
About this study
Official title: Primary Versus Secondary Implant Stability in Relation to Gap Distance of Immediate Implant With Immediate Loading by Provisional Restoration
Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion
Read the detailed description
In this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score
- Conditions
- Maintain the Esthetic
- Being tested
- Tooth guided immediate implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth guided immediate implant placementProcedure or surgery
The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the single rooted teeth to be extracted as a reference and as aid for apical engagement
| Study group | Role | What they receive |
|---|---|---|
| Patient with non restorable teeth | Patient with non restorable teeth located in smile line needs extraction with immediate implantation and immediate provisionalization to improve psychiatric effect of tooth loss Receives: Procedure: Tooth guided immediate implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant primary stability
The stability measured by resonance frequancy analysis device (osstell)
Measured: 0 day
Jumping gab
The gab that located between the implant surface and buccal plate
Measured: 0 day
Pink esthetic score
Denote the esthetic profile of bone and gingiva
Measured: 0 day, before extraction and implant placement
Secondary outcomes (3)
Implant secondary stability
The stability measured by resonance frequancy analysis device (osstell)
Measured: Up to 16 weeks
Ridge reduction
The amount of reduction in buccal profile of the alveolar ridge
Measured: Up to 16 weeks
Pink esthetic score
Denote the esthetic profile of bone and gingiva
Measured: after implantation By 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start27 Jan 2021
- Primary completion27 Nov 2021
- Study completion27 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maintain the EstheticStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalya Munther Naeem, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006014
- Sponsor's protocol ID
- 1427705
- Status last verified
- Mar 2022
- First submitted
- 4 Aug 2021
- Last updated
- 21 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Versus Secondary Implant Stability in Relation to Gap Distance of Immediate Implant With Immediate Loading by Provisional Restoration
- ClinicalTrials.gov ID
- NCT05006014
- Acronym / sponsor ID
- 1427705
- Conditions
- Maintain the Esthetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 27 Mar 2022 (estimated)
- First posted
- 16 Aug 2021 (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.
Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion
Detailed description
In this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with non restorable teeth | – | Procedure: Tooth guided immediate implant placementPatient with non restorable teeth located in smile line needs extraction with immediate implantation and immediate provisionalization to improve psychiatric effect of tooth loss |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult with non restorable dental unit seeking for immediate implantation with provisionalization
Key inclusion criteria (4 listed)
- Medical and psychological fitness for minor oral surgery.
- Age 20-60 years.
- medium to thick gingival biotype.
- buccal plate thickness more than (1mm).
Key exclusion criteria (8 listed)
- Smoking habit.
- Diabetes mellitus.
- A systemic disorder that is contraindicated for the minor surgical procedure.
- Pregnancy or lactation.
- Any irradiation in head and neck area.
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 |
|---|---|---|
| Tooth guided immediate implant placementThe technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the single rooted teeth to be extracted as a reference and as aid for apical engagement | Procedure or surgery | Patient with non restorable teeth |
Primary outcome
Implant primary stability
Time frame: 0 day
The stability measured by resonance frequancy analysis device (osstell)
Jumping gab
Time frame: 0 day
The gab that located between the implant surface and buccal plate
Pink esthetic score
Time frame: 0 day, before extraction and implant placement
Denote the esthetic profile of bone and gingiva
3 secondary outcomes
Implant secondary stability
Time frame: Up to 16 weeks
Ridge reduction
Time frame: Up to 16 weeks
Pink esthetic score
Time frame: after implantation By 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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?
An observational study of Maintain the Esthetic, run by University of Baghdad at 1 site in Iraq.
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 21 Mar 2022. 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 Iraq. 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 Dalya M Naeem, B.D.S (07705653307 ext. +964, dahlia93m@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant primary stability (time frame: 0 day). The study lists 3 primary outcomes in all. 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 21 Mar 2022.