Completely Edentulous PatientsNCT03814070
Prosthesis and Implant Survival in Immediately Loaded Temporary Full Arch Restorations
A study testing Fiber-reinforced framework and No framework in people with Completely Edentulous Patients, run by Nermeen Ahmed Hassan.
Trial summary
In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous Patients
- What is being tested?
- Fiber-reinforced framework and No framework
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Mar 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous patients.
- Patients with proper amount of attached gingiva (≥2 mm)
Who cannot join
- Patients having a medical condition that absolutely contraindicates implant placement.
- Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 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 with history of bruxism
- If insertion torque for the implants is less than 35 Ncm
About this study
Official title: Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial
In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use.
Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.
- Conditions
- Completely Edentulous Patients
- Being tested
- Fiber-reinforced framework, No framework
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiber-reinforced frameworkProcedure or surgery
Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations
No frameworkProcedure or surgery
Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
| Study group | Role | What they receive |
|---|---|---|
| Non-reinforced full arch acrylic restorations | Active comparator | Not described Receives: Procedure: No framework |
| full arch acrylic restorations with fiber-reinforced framework | Experimental | Not described Receives: Procedure: Fiber-reinforced framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthesis survival
Clinical evaluation of any fracture in the prosthesis
Measured: 4 months
Secondary outcomes (2)
Implant survival
Clinical evaluation of implant loss
Measured: 4 months
Peri-implant crestal bone loss during healing
Crestal bone loss around implants is to be measured using periapical x ray with parallel technique in millemeters
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 posted23 Jan 2019
- Study startFeb 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Edentulous PatientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nermeen Ahmed Hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermeen Ahmed Hassan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03814070
- Sponsor's protocol ID
- Nermeen Ahmed Hassan
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 23 Jan 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 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthesis and Implant Survival in Immediately Loaded Full Arch Restorations Using Fiber Reinforced Versus Non-reinforced Temporary Frameworks: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03814070
- Acronym / sponsor ID
- Nermeen Ahmed Hassan
- Conditions
- Completely Edentulous Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Nermeen Ahmed HassanUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 23 Jan 2019 (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.
In immediate loading of implants of completely edentulous patients, the most common post-surgical complication following the surgery noted in the dental literature is fracture of the provisional restoration with rates ranging from 4.17% to 41%. Most of these fractures occur because polymethyl methacrylate (PMMA) materials are inadequate and have low rigidity to withstand extended periods of heavy occlusal use.
Fractures of full arch provisional restorations during healing are concerning, because they eliminate cross-arch stabilization and disrupt stress distribution patterns which might jeopardize implant osseointegration affecting the survival rates for implants. Therefore, it is important to look for another material that has higher rigidity than PMMA and can withstand masticatory forces for extended periods without fractures or load concentration on the implants during the osseointegration period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-reinforced full arch acrylic restorations | Active comparator | Procedure: No framework |
| full arch acrylic restorations with fiber-reinforced framework | Experimental | Procedure: Fiber-reinforced framework |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completely edentulous patients.
- Patients with proper amount of attached gingiva (≥2 mm)
Key exclusion criteria (6 listed)
- Patients having a medical condition that absolutely contraindicates implant placement.
- Patients with uncontrolled diabetes, assessed by measuring glycosylated hemoglobin (HbA1c). (greater than 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 with 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 |
|---|---|---|
| Fiber-reinforced frameworkGlass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations | Procedure or surgery | full arch acrylic restorations with fiber-reinforced framework |
| No frameworkNon-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments. | Procedure or surgery | Non-reinforced full arch acrylic restorations |
Primary outcome
Prosthesis survival
Time frame: 4 months
Clinical evaluation of any fracture in the prosthesis
2 secondary outcomes
Implant survival
Time frame: 4 months
Peri-implant crestal bone loss during healing
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fiber-reinforced framework and No framework in people with Completely Edentulous Patients, run by Nermeen Ahmed Hassan.
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 6 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 23 Jan 2019. 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?
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?
Prosthesis survival (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 23 Jan 2019.