Immediate ImplantNCT06040788
Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment
A study testing immediate implant placement with customized healing abutment in people with Immediate Implant and Esthetic Zone, run by Cairo University.
Trial summary
The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Implant, Esthetic Zone, Customized Healing Abutment
- What is being tested?
- immediate implant placement with customized healing abutment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Nov 2024
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient-related criteria:
- Adults at or above the age of 21.
- Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- Able to tolerate surgical periodontal procedures.
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- Good oral hygiene.
- Compliance with the maintenance program.
- Provide informed consent.
- Accepts the one-year follow-up period.
- Teeth related criteria:
- Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
- Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
- Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm.
Who cannot join
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft placement.
- Patients with parafunctional habits
About this study
Official title: Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial
The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. The main question it aims to answer are:
- Will the amount of collapse be greater when the root is proclined or outside the bone housing?
- Will no additional intervention be needed with immediate implants in the esthetic zone if we have better anatomy that will help hinder the collapse? Participants will receive immediate dental implants with customized healing abutments
- Conditions
- Immediate Implant, Esthetic Zone, Customized Healing Abutment, Tissue Collapse, Tissue Dimensional Changes
- Being tested
- immediate implant placement with customized healing abutment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate implant placement with customized healing abutmentProcedure or surgery
immediate implant placement with customized healing abutment
| Study group | Role | What they receive |
|---|---|---|
| immediate implant placement with customized healing abutment | Experimental | Not described Receives: Procedure: immediate implant placement with customized healing abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of labiopalatal ridge collapse
radiographic Labiopalatal ridge collapse via CBCT
Measured: 1 year
Amount of bone labial to the implant
Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT
Measured: 1 year
Secondary outcomes (4)
Amount of vertical crestal bone resorption in millimeters
Vertical crestal bone changes via CBCT in mm
Measured: 1 year
Amount of change in buccal soft issue contour in mm3
volumetric analysis of the amount of change in buccal soft issue contour in mm3
Measured: 1 year
amount of Mid facial recession in millimeters
Mid facial recession in n millimeters
Measured: 1 year
Pink esthetic score
1-14 scale
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 posted18 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immediate ImplantStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Mohamed Fouad Shemais, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040788
- Sponsor's protocol ID
- IDCE.N5
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tooth Angulation, Alveolar and Basal Bone Anatomical Characteristics on Soft and Hard Tissue Alterations Around Immediate Implants With Customized Healing Abutment. A 1-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06040788
- Acronym / sponsor ID
- IDCE.N5
- Conditions
- Immediate Implant, Esthetic Zone, Customized Healing Abutment, Tissue Collapse, Tissue Dimensional Changes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 18 Sep 2023 (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.
The goal of this clinical trial is to investigate the effect of different anatomical variations in terms of root angulation, alveolar bone and basal bone morphology on soft and hard tissue alterations in patients with non-restorable teeth in the inter-canine region undergoing immediate implantation. The main question it aims to answer are:
- Will the amount of collapse be greater when the root is proclined or outside the bone housing?
- Will no additional intervention be needed with immediate implants in the esthetic zone if we have better anatomy that will help hinder the collapse? Participants will receive immediate dental implants with customized healing abutments
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immediate implant placement with customized healing abutment | Experimental | Procedure: immediate implant placement with customized healing abutment |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adults at or above the age of 21.
- Non-restorable maxillary inter-canine tooth requiring extraction and needed an implant placing therapy.
- The failing tooth will have adjacent and opposing natural teeth.
- Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
- Able to tolerate surgical periodontal procedures.
Key exclusion criteria (6 listed)
- Patients diagnosed with periodontal diseases.
- Current or previous smokers.
- Pregnant and lactating females.
- Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
- Patients with active infection related at the site of implant/bone graft placement.
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 placement with customized healing abutmentimmediate implant placement with customized healing abutment | Procedure or surgery | immediate implant placement with customized healing abutment |
Primary outcome
Amount of labiopalatal ridge collapse
Time frame: 1 year
radiographic Labiopalatal ridge collapse via CBCT
Amount of bone labial to the implant
Time frame: 1 year
Amount of bone labial to the implant at three levels 0, 2, and 5mmm below the alveolar crest via CBCT
4 secondary outcomes
Amount of vertical crestal bone resorption in millimeters
Time frame: 1 year
Amount of change in buccal soft issue contour in mm3
Time frame: 1 year
amount of Mid facial recession in millimeters
Time frame: 1 year
Pink esthetic score
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 18 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing immediate implant placement with customized healing abutment in people with Immediate Implant and Esthetic Zone, run by Cairo University.
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 14 inclusion and 6 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Amount of labiopalatal ridge collapse (time frame: 1 year). The study lists 2 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 18 Sep 2023.