Soft Tissue HealingrandomisedNCT06733870
Peri-implant Soft Tissue and Bone Evaluation in Fully Computer Guided Immediate Implants
A study testing guided immediate implant surgery in people with Soft Tissue Healing, run by Ain Shams University at 1 site in Egypt.
Trial summary
Prospective evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Healing
- What is being tested?
- guided immediate implant surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2023to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Males and females aged at least 18 years.
- Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
- Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
- Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
- Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
- Thick gingival biotype.
Who cannot join
- Presence of active infection around the failing tooth or adjacent teeth.
- Presence of active periodontal disease and gingival recession in the esthetic area.
- Systemic diseases , pregnancy and smoking.
- Recent orthodontic treatment.
- Bruxism and parafunctional habits .
- Labial plate dehiscence, fenestration, or loss after tooth extraction
- Inability to achieve primary stability after implant placement
- Vulnerable groups: prisoners, mentally retarded, etc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peri-implant Soft Tissue and Bone Evaluation of One Abutment One Time Concept Following Fully Computer Guided Immediate Implants
Prospective evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement.
Read the detailed description
Patient selection:
The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.
Sample size analysis :
A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.
These patients will be divided randomly into 2 groups:
Group I: will include 8 patients who will undergo guided immediate implant placement and immediate provisionalization with preplanned PMMA provisional restoration on Ti-Base Group II: will include 8 patients who will undergo guided immediate implant placement and immediate loading by using a final CAD/CAM customized abutment and a cemented CAD/CAM fabricated PMMA provisional restoration.
- Conditions
- Soft Tissue Healing
- Being tested
- guided immediate implant surgery
- Keywords
- One abutment one time, Full digital workflow, Immediate implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guided immediate implant surgeryProcedure or surgery
fully guided immediate implant placement and loading
| Study group | Role | What they receive |
|---|---|---|
| immediate load with provisional restoration | Other | immediate load with PMMA crown on Ti base Receives: Procedure: guided immediate implant surgery |
| immediate load with one abutment one time concept | Other | immediate ;load with customized final abutment and PMMA crown Receives: Procedure: guided immediate implant surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant soft tissue volumetric change
- intraoral scanner is used to obtain before and after 3D scans
- 3D scans are superimposed on a software and the difference in volume can be measured and detected by a color map
Measured: 4 months
Secondary outcomes (1)
Esthetic evaluation
- Esthetic evaluation will be done by calculating the pink esthetic score (PES)
- standardized photographs are assesed to measure the changes in PES
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start11 Oct 2023
- Primary completion11 Feb 2024
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue HealingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Abd El Nasser, Ain Shams University
- Investigators
- Mohamed Bissar, Associate professor, Study director, Faculty of dentistry- Ain Shams UniversityIngy Nouh, lecturer, Study director, Faculty of dentistry- Ain Shams UniversityHala Kamal, Professor, Study director, Faculty of dentistry- Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733870
- Sponsor's protocol ID
- FDASU.REC ID 032124
- Acronym
- randomised
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-implant Soft Tissue and Bone Evaluation of One Abutment One Time Concept Following Fully Computer Guided Immediate Implants
- ClinicalTrials.gov ID
- NCT06733870
- Acronym / sponsor ID
- randomised / FDASU.REC ID 032124
- Conditions
- Soft Tissue Healing
- Keywords
- One abutment one time, Full digital workflow, Immediate implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 11 Oct 2023 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 13 Dec 2024 (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 evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement.
Detailed description
Patient selection:
The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.
Sample size analysis :
A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.
These patients will be divided randomly into 2 groups:
Group I: will include 8 patients who will undergo guided immediate implant placement and immediate provisionalization with preplanned PMMA provisional restoration on Ti-Base Group II: will include 8 patients who will undergo guided immediate implant placement and immediate loading by using a final CAD/CAM customized abutment and a cemented CAD/CAM fabricated PMMA provisional restoration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate load with provisional restoration | Other | Procedure: guided immediate implant surgeryimmediate load with PMMA crown on Ti base |
| immediate load with one abutment one time concept | Other | Procedure: guided immediate implant surgeryimmediate ;load with customized final abutment and PMMA crown |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females aged at least 18 years.
- Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
- Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
- Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
- Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
Key exclusion criteria (8 listed)
- Presence of active infection around the failing tooth or adjacent teeth.
- Presence of active periodontal disease and gingival recession in the esthetic area.
- Systemic diseases , pregnancy and smoking.
- Recent orthodontic treatment.
- Bruxism and parafunctional habits .
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 |
|---|---|---|
| guided immediate implant surgeryfully guided immediate implant placement and loading | Procedure or surgery | immediate load with one abutment one time concept, immediate load with provisional restoration |
Primary outcome
peri-implant soft tissue volumetric change
Time frame: 4 months
* intraoral scanner is used to obtain before and after 3D scans * 3D scans are superimposed on a software and the difference in volume can be measured and detected by a color map
1 secondary outcome
Esthetic evaluation
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Mohamed Bissar, Associate professor study director
Faculty of dentistry- Ain Shams University
Ingy Nouh, lecturer study director
Faculty of dentistry- Ain Shams University
Hala Kamal, Professor study director
Faculty of dentistry- Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided immediate implant surgery in people with Soft Tissue Healing, run by Ain Shams 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 6 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: under way, not looking for participants, as of the sponsor's last update on 13 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
peri-implant soft tissue volumetric change (time frame: 4 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 13 Dec 2024.