Randomized Clinical TrialNCT03640091
Pre-extractive Inter-radicular Implant Bed Preparation Versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars
A study testing Post-extractive inter-radicular implant bed preparation in people with Randomized Clinical Trial, run by Cairo University at 1 site in Egypt.
Trial summary
Pre-extractive Inter-radicular Implant Bed Preparation versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Randomized Clinical Trial
- What is being tested?
- Post-extractive inter-radicular implant bed preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with badly decayed posterior molar teeth.
- Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal should be equal to or more than 10 mm
Who cannot join
- Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal equal to or less than 8 mm.
- Heavy smokers more than 20 cigarettes per day.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
Mohamed Abdo Elshoaby, Bachelor, 01064620838 ext. 0132460913, Mohamedalshoaibi89@gmail.com
Ahmed Abdo Elshoaby, Bachelor, 01156989210 ext. 0132475866, Mando_abdo_2008@yahoo.com
About this study
Official title: Implant in Mandibular Molars
Pre-extractive Inter-radicular Implant Bed Preparation versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars
- Conditions
- Randomized Clinical Trial
- Being tested
- Post-extractive inter-radicular implant bed preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-extractive inter-radicular implant bed preparationProcedure or surgery
Implant placement in mandibular molars
| Study group | Role | What they receive |
|---|---|---|
| Pre-extractive inter-radicular implant bed preparation | Experimental | Not described Receives: Procedure: Post-extractive inter-radicular implant bed preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
By ostell in newten scale
Measured: 1 year
Secondary outcomes (1)
Marginal bone loss
By cone beam xray in millimeters 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 posted21 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Randomized Clinical TrialStudies 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abdel wahid elshoaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640091
- Sponsor's protocol ID
- Cairo university 1
- Status last verified
- Feb 2019
- First submitted
- 11 Jul 2018
- Last updated
- 5 Feb 2019
- 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 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant in Mandibular Molars
- ClinicalTrials.gov ID
- NCT03640091
- Acronym / sponsor ID
- Cairo university 1
- Conditions
- Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 21 Aug 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.
Pre-extractive Inter-radicular Implant Bed Preparation versus Conventional Post-extractive Inter-radicular Implant Bed Preparation in Mandibular Molars
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-extractive inter-radicular implant bed preparation | Experimental | Procedure: Post-extractive inter-radicular implant bed preparation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with badly decayed posterior molar teeth.
- Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal should be equal to or more than 10 mm
Key exclusion criteria (2 listed)
- Distance from height of inter-radicular furcation of mandibular molars to the mandibular canal equal to or less than 8 mm.
- Heavy smokers more than 20 cigarettes per day.
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 |
|---|---|---|
| Post-extractive inter-radicular implant bed preparationImplant placement in mandibular molars | Procedure or surgery | Pre-extractive inter-radicular implant bed preparation |
Primary outcome
Implant stability
Time frame: 1 year
By ostell in newten scale
1 secondary outcome
Marginal bone loss
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 5 Feb 2019.
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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 Post-extractive inter-radicular implant bed preparation in people with Randomized Clinical Trial, run by Cairo 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 2 inclusion and 2 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 5 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Abdo Elshoaby, Responsible (01064620838 ext. 0132460913, Mando_abdo_2008@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (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 5 Feb 2019.