Tooth FracturesNCT03224273
Clinical Assessment of Two Inlay -Retained Bridge Designs
A study testing proximal box inlay retained bridge in people with Tooth Fractures, run by Cairo University.
Trial summary
in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less… Read more about this study
- Who is it for?
- Ages 18 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Fractures
- What is being tested?
- proximal box inlay retained bridge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Feb 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 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Absence of periapical or periodontal or diseases
- sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
- Maintenance of good oral hygiene
- No tooth mobility or grade 1 can be accepted
- Sufficient occluso-gingival tooth height (5mm)
- Good alignment of abutment teeth
- mesiodistal edentulous space preferred not exceed 12mm
Who cannot join
- Patients under the age of 18 or being incapable of taking out a contract
- Patients with any medical condition that impaired correct oral hygiene
- Endodontic ally treated abutment teeth
- a conspicuous medical or psychological history
- bruxism, or known allergic reaction to the materials used
- limited vertical space for the required connector height of 4mm
- pregnant female patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Assessment of Two Inlay -Retained Bridge Designs (Proximal Box Shaped and Inlay Shaped) in Missing Posterior Teeth Cases
in the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.
Read the detailed description
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. In comparison With the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost
- Conditions
- Tooth Fractures
- Being tested
- proximal box inlay retained bridge
- Keywords
- proximal box design preparation
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proximal box inlay retained bridgeOther
Also called all ceramic inlay retained bridge
inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area
| Study group | Role | What they receive |
|---|---|---|
| ( proximal box design) | Experimental | The proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor. Receives: Other: proximal box inlay retained bridge |
| ( inlay shaped design) | Active comparator | The occlusal inlay has a preparation depth of 2.0 mm for the ceramic. The occlusal preparation ( 4 mm wide and extend 4mm for premolar and 6 mm for molar mesiodistally Receives: Other: proximal box inlay retained bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
fracture
resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score
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 Jul 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth FracturesStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gomaa soliman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224273
- Sponsor's protocol ID
- CEBD-CU-2017-07-14
- Status last verified
- Sep 2017
- First submitted
- 18 Jul 2017
- Last updated
- 12 Sep 2017
- 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 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Two Inlay -Retained Bridge Designs (Proximal Box Shaped and Inlay Shaped) in Missing Posterior Teeth Cases
- ClinicalTrials.gov ID
- NCT03224273
- Acronym / sponsor ID
- CEBD-CU-2017-07-14
- Conditions
- Tooth Fractures
- Keywords
- proximal box design preparation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 21 Jul 2017 (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 the last years, dentistry is going to the concept of conservatism to preserve the most amount of tooth structure, so the evolution of new ceramic materials with invasive designs like (inlay- shaped and proximal box shaped) inlay retained bridge, the investigators can restore single missing posterior teeth with less invasive techniques and less rate of restoration fracture.
Detailed description
It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and postoperative sensitivity. In comparison With the inlay-retained bridge, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ( proximal box design) | Experimental | Other: proximal box inlay retained bridgeThe proximal box at least ( 1mm wide and has 6◦ divergences, and extend 2 mm apical to the isthmus floor. |
| ( inlay shaped design) | Active comparator | Other: proximal box inlay retained bridgeThe occlusal inlay has a preparation depth of 2.0 mm for the ceramic. The occlusal preparation ( 4 mm wide and extend 4mm for premolar and 6 mm for molar mesiodistally |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Absence of periapical or periodontal or diseases
- sound abutment teeth or with small caries or filling on occlusal or proximal surfaces
- Maintenance of good oral hygiene
- No tooth mobility or grade 1 can be accepted
- Sufficient occluso-gingival tooth height (5mm)
Key exclusion criteria (7 listed)
- Patients under the age of 18 or being incapable of taking out a contract
- Patients with any medical condition that impaired correct oral hygiene
- Endodontic ally treated abutment teeth
- a conspicuous medical or psychological history
- bruxism, or known allergic reaction to the materials used
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 |
|---|---|---|
| proximal box inlay retained bridgeAlso: all ceramic inlay retained bridgeinlay retained bridge is the less invasive type to restore single missing teeth in the posterior area | Other | ( inlay shaped design), ( proximal box design) |
Primary outcome
fracture
Time frame: 1 year
resistance of restoration to disintegrate and the assessment for the outcome will be done by using MUSPHS scale and the measuring unit is score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
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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 proximal box inlay retained bridge in people with Tooth Fractures, 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 7 inclusion and 7 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 12 Sep 2017. 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 Gomaa Abdallah Soliman, MDS (+201145794545, gomaasoliman@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fracture (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 12 Sep 2017.