Edentulous JawNCT03674554
Prosthetic Complications of Screw Retained Restoration
A study testing titanium bases using intra oral luting cement technique and transmucosal abutment in people with Edentulous Jaw and Edentulous Alveolar Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Edentulous Alveolar Ridge, Edentulous Mouth
- What is being tested?
- titanium bases using intra oral luting cement technique and transmucosal abutment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Jul 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- - Completely edentulous patients
- Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
- Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
- Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
- Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )
Who cannot join
- - Patients having a medical condition that absolutely contraindicates implant placement.
- Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
- Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
- Patients who are having complete lower denture
- Patients who have history of bruxism
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo Universty
Cairo, 01234
mostafa said hosny, M.Sc. 2018, 01007799234 ext. 002, drdental88@gmail.com
amr hosny elkhadem, phd, 01001162401 ext. 002, amrelkhadem@gmail.com
About this study
Official title: Prosthetic Complications of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Base in Implant Supported Complete Overdentures Randomized Clinical Trial
On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction
- Conditions
- Edentulous Jaw, Edentulous Alveolar Ridge, Edentulous Mouth
- Being tested
- titanium bases using intra oral luting cement technique, transmucosal abutment
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium bases using intra oral luting cement techniqueProcedure or surgery
a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
transmucosal abutmentProcedure or surgery
a full-arch screw-retained implant prosthesis with transmucosal abutment
| Study group | Role | What they receive |
|---|---|---|
| titanium bases group | Experimental | full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique Receives: Procedure: titanium bases using intra oral luting cement technique |
| transmucosal abutment group | Experimental | a full-arch screw-retained implant prosthesis with transmucosal abutment Receives: Procedure: transmucosal abutment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abutment screw loosening
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Secondary outcomes (6)
Prosthetic screw loosening
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Prosthetic screw fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Abutment screw fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Veneer fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Framework fracture
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Ti-bases de-cementation
Measuring device :Clinical visual inspection / Measuring unit:Binary
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa said hosny, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674554
- Sponsor's protocol ID
- 28809010109913
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Complications of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Base in Implant Supported Complete Overdentures Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03674554
- Acronym / sponsor ID
- 28809010109913
- Conditions
- Edentulous Jaw, Edentulous Alveolar Ridge, Edentulous Mouth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 17 Sep 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.
On of the main fixed prosthetic options of completely edentulous patients is the screw-retained implant supported prosthesis which was constructed on transmucosal abutments with its encountered problems such as: hardness to make it passively seated with multiple screw fracture and loosening problems and multiple encountered veneer material fracture and so there effect on patient satisfaction with multiple maintenance recalls.so, the investigators want to try a new technique of fabrication which was proposed for reducing the problems of lack of passivity which is the intraoral luting cement technique on titanium bases with reduced screw number but, with luting cement problems as de-cementation and cement biological effects on soft tissues and bone and there effect on number of patient recall visits and maintenance and so there effect on patient satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| titanium bases group | Experimental | Procedure: titanium bases using intra oral luting cement techniquefull-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique |
| transmucosal abutment group | Experimental | Procedure: transmucosal abutmenta full-arch screw-retained implant prosthesis with transmucosal abutment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- - Completely edentulous patients
- Patients with completely edentulous ridges have an opposing natural dentition or implant supported overdenture
- Completely edentulous patients (with the above mentioned criteria) who have proper amount of attached gingiva (≥2 mm) or to be created
- Completely edentulous patients (with the above mentioned criteria) who have no history of bruxism
- Completely edentulous patients (with the above mentioned criteria) who were free or controlled diabetic assessed by measuring glycosylated haemoglobin (HbA1c). (lesser than or equal to 6.4 percent )
Key exclusion criteria (5 listed)
- - Patients having a medical condition that absolutely contraindicates implant placement.
- Patients with uncontrolled diabetes, assessed by measuring glycosylated haemoglobin (HbA1c). (greater than to 6.4 percent )
- Potentially uncooperative patients who are not willing to go through the proposed interventions. - Moderate-to-heavy daily smokers* (who report consuming at least 11 cigarettes/day).
- Patients who are having complete lower denture
- Patients who have history of bruxism
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 |
|---|---|---|
| titanium bases using intra oral luting cement techniquea full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique | Procedure or surgery | titanium bases group |
| transmucosal abutmenta full-arch screw-retained implant prosthesis with transmucosal abutment | Procedure or surgery | transmucosal abutment group |
Primary outcome
Abutment screw loosening
Time frame: 12 months
Measuring device :Clinical visual inspection / Measuring unit:Binary
6 secondary outcomes
Prosthetic screw loosening
Time frame: 12 months
Prosthetic screw fracture
Time frame: 12 months
Abutment screw fracture
Time frame: 12 months
Veneer fracture
Time frame: 12 months
Framework fracture
Time frame: 12 months
Ti-bases de-cementation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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 titanium bases using intra oral luting cement technique and transmucosal abutment in people with Edentulous Jaw and Edentulous Alveolar Ridge, 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 5 inclusion and 5 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 17 Sep 2018. 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 mostafa said hosny, M.Sc. 2018 (0100779234 ext. 002, drdental88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abutment screw loosening (time frame: 12 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 17 Sep 2018.