Bone LossNCT03671668
Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration
A study testing titanium bases using intra oral luting cement technique in people with Bone Loss, run by Cairo University.
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
- Bone Loss
- What is being tested?
- titanium bases using intra oral luting cement technique
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 1 Sep 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 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
No sites are listed yet.
About this study
Official title: Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Bases in Implant Supported Complete Overdentures: A 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, we 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
- Bone Loss
- Being tested
- titanium bases using intra oral luting cement technique
- Medical subject headings
- Bone Diseases, Metabolic
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 techniqueOther
comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction
| Study group | Role | What they receive |
|---|---|---|
| Screw retained prosthesis on transmucosal abutments | Active comparator | Not described Receives: Other: titanium bases using intra oral luting cement technique |
| Screw retained prosthesis on titanium bases | Experimental | Not described Receives: Other: titanium bases using intra oral luting cement technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal bone loss
measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters
Measured: 6 to 12 months
Secondary outcomes (1)
Patients satisfaction
Numerical Rating Scale (NRS) [11-point ordinal scale from 0 (completely dissatisfied) to 10 (completely satisfied)]
Measured: 6 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start1 Nov 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Model description
- Completely edentulous patients
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed saber mohamed ahmed, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671668
- Sponsor's protocol ID
- 28905011809519
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2018
- Last updated
- 26 Oct 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 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crestal Bone Loss and Patient Satisfaction of Screw Retained Restoration Using Multi-unit Abutments Versus Intra-oral Luting on Titanium Bases in Implant Supported Complete Overdentures: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03671668
- Acronym / sponsor ID
- 28905011809519
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 14 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, we 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
- None (open label)
- Number of arms
- 2
- Model description
- Completely edentulous patients
| Arm | Type | Receives |
|---|---|---|
| Screw retained prosthesis on transmucosal abutments | Active comparator | Other: titanium bases using intra oral luting cement technique |
| Screw retained prosthesis on titanium bases | Experimental | Other: titanium bases using intra oral luting cement technique |
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 techniquecomparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction | Other | Screw retained prosthesis on titanium bases, Screw retained prosthesis on transmucosal abutments |
Primary outcome
Crestal bone loss
Time frame: 6 to 12 months
measuring crestal bone loss around implants using periapical x ray with parallel technique in millemeters
1 secondary outcome
Patients satisfaction
Time frame: 6 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 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.
Questions about this trial
What is this clinical trial studying?
A study testing titanium bases using intra oral luting cement technique in people with Bone Loss, 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 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 26 Oct 2018. 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?
Contact Mohamed Saber Ahmed (00201068316376 ext. 0020, mohamed.saber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crestal bone loss (time frame: 6 to 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 26 Oct 2018.