Dental ImplantsUWDNCT05972447
Ultra-wide Diameter Implants in Mandibular Molars
A study testing Immediate implant placement of Ultrawide diameter dental implants in people with Dental Implants, run by Abdelrahman Elshahawy at 1 site in Egypt.
Trial summary
The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket] Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Immediate implant placement of Ultrawide diameter dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 20 May 2021to 3 Mar 2022
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients ranging from 20-40 years.
- Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
- Non-restorable mandibular molar teeth.
- Available bone with adequate width and buccolingual dimensions.
- Peri-implant bone defect should be 2mm or lesser.
Who cannot join
- Smokers.
- Medically compromised patients like uncontrolled diabetes and coagulation disorders.
- Tooth with periapical pathosis or bony defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars
The goal of this [clinical trial] is to [To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket]
Read the detailed description
the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.
- Conditions
- Dental Implants
- Being tested
- Immediate implant placement of Ultrawide diameter dental implants
- Keywords
- UWD implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate implant placement of Ultrawide diameter dental implantsProcedure or surgery
Also called Ultrawide diameter dental implants
immediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth
| Study group | Role | What they receive |
|---|---|---|
| non-restorable mandibular molar teeth | Other | patients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants Receives: Procedure: Immediate implant placement of Ultrawide diameter dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean value of implant stability
The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.
Measured: up to 6months
the mean value of peri-implant bone density
Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.
Measured: up to 9 months
the mean value of Marginal bone loss
marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.
Measured: up to 9months
the mean of peri-implant probing depth
Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start20 May 2021
- Primary completion12 Jan 2022
- Study completion3 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdelrahman Elshahawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abdelrahman Elshahawy, Alexandria University
- Investigators
- Gaafar N Elhalawani, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972447
- Sponsor's protocol ID
- 0210-01/2021
- Acronym
- UWD
- Status last verified
- Jul 2023
- First submitted
- 17 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immediately Placed Ultra-wide Diameter Implant Placed in Mandibular Molars
- ClinicalTrials.gov ID
- NCT05972447
- Acronym / sponsor ID
- UWD / 0210-01/2021
- Conditions
- Dental Implants
- Keywords
- UWD implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abdelrahman ElshahawyUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 12 Jan 2022 (actual)
- Study completion
- 3 Mar 2022 (actual)
- First posted
- 2 Aug 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 [To evaluate both the clinical and radiographical outcome on osteointegration and peri-implant bone density when using ultra wide diameter implant placed immediately in molar extraction socket]
Detailed description
the aim of this study is to evaluate the clinical and radiographical outcomes on osseointegration and peri-implant bone density when using 12 ultrawide diameter dental implants placed immediately in 12 patients after atraumatic extraction of non-restorable mandibular molars without raising a flap or using bone grafts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| non-restorable mandibular molar teeth | Other | Procedure: Immediate implant placement of Ultrawide diameter dental implantspatients with non restorable mandibular molar teeth without any periapical pathosis to be extracted and implanted immediately using ultrawide diameter dental implants |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients ranging from 20-40 years.
- Adequate bone beyond teeth apices without jeopardizing any anatomical structure.
- Non-restorable mandibular molar teeth.
- Available bone with adequate width and buccolingual dimensions.
- Peri-implant bone defect should be 2mm or lesser.
Key exclusion criteria (3 listed)
- Smokers.
- Medically compromised patients like uncontrolled diabetes and coagulation disorders.
- Tooth with periapical pathosis or bony defects.
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 of Ultrawide diameter dental implantsAlso: Ultrawide diameter dental implantsimmediate placement of ultrawide diameter dental implants in a fresh extraction socket of mandibular molar teeth | Procedure or surgery | non-restorable mandibular molar teeth |
Primary outcome
the mean value of implant stability
Time frame: up to 6months
The implant stability was measured by implant stability meter (Osstell™) immediately postoperative and at 6 months.
the mean value of peri-implant bone density
Time frame: up to 9 months
Radiographic evaluation of the bone density around each implant was done using OnDemand3D™.
the mean value of Marginal bone loss
Time frame: up to 9months
marginal bone levels were calculated from the reconstructed corrected sagittal views by drawing a line parallel to the implant serration extending from the crestal bone to the apical end of the implant. Average readings of the two sides at each interval were calculated and tabulated for statistical analysis.
the mean of peri-implant probing depth
Time frame: up to 9 months
Probing depth was assessed according to Gallagher and Silver Probing pocket depth refers to the distance between the gingival margin and the bottom of the pocket
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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.
Gaafar N Elhalawani study director
Alexandria 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 Immediate implant placement of Ultrawide diameter dental implants in people with Dental Implants, run by Abdelrahman Elshahawy 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the mean value of implant stability (time frame: up to 6months). The study lists 4 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 2 Aug 2023.