Tooth DecayNCT05250232
One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
A study testing onlays conservative and onlays conventional in people with Tooth Decay, run by Cairo University.
Trial summary
the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Tooth Decay
- What is being tested?
- onlays conservative and onlays conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 27 Feb 2022to 12 Aug 2023
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All subjects are required to be:
- 1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:
- Decayed teeth
- Teeth restored with defected filling restorations
- Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria
- Patient less than 18 or more than 50 years
Show all 14Show fewer
- Patient with active resistant periodontal diseases
- Patients with poor oral hygiene and uncooperative patients
- Pregnant women
- Patients in the growth stage with partially erupted teeth
- Psychiatric problems or unrealistic expectations
- Lack of opposing dentition in the area of interest
- -
- -
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Eman Hussein contact
About this study
the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect
- Conditions
- Tooth Decay
- Being tested
- onlays conservative, onlays conventional
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlays conservativeOther
Partial coverage of cusps with shoulder finish line
onlays conventionalOther
all coverage of cusps as overlay with shoulder finish line
| Study group | Role | What they receive |
|---|---|---|
| onlays conservative | Experimental | conservative onlays preparation with partial cusp coverage only defective cusps Receives: Other: onlays conservative |
| onlays conventional | Active comparator | onlays preparation design conventional as all cusps covered with shoulder finish line preparation Receives: Other: onlays conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of fracture resistance
fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores)
- alpha no evidence of fracture
- bravo evidence of fracture
Measured: one year
Secondary outcomes (2)
evaluation of marginal adaptation
marginal adaptation of restorations postoperatively assessment by Measuring device Modified USPHS Criteria Measuring unit .Discrete(scores) use explorer
- alpha no visible evidence of ditching along the margin
- bravo visible evidence of ditching along the margin not extending to the DE junction
- charlie mismatch between restoration and tooth structure within the normal range of color, shade ,translucency
Measured: 1 year
evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity
patient satisfaction of restoration use Questionnaire VAS* Measuring device Measuring unit Numerical(discrete) ('0' unsatisfied-'10' satisfied)
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 posted22 Feb 2022
- Study start27 Feb 2022 (estimated)
- Primary completion15 Jan 2023 (estimated)
- Study completion12 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DecayStudies 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, howaida ahmed el-hagrasy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250232
- Sponsor's protocol ID
- resala
- Status last verified
- Feb 2022
- First submitted
- 9 Jan 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Clinical Evaluation of Conservative Versus Conventional Ceramic Onlays
- ClinicalTrials.gov ID
- NCT05250232
- Acronym / sponsor ID
- resala
- Conditions
- Tooth Decay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 27 Feb 2022 (estimated)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 12 Aug 2023 (estimated)
- First posted
- 22 Feb 2022 (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.
the aim of present study is to evaluate clinically the fracture liability , marginal adaptation , and patient satisfaction of conservative versus conventional ceramic Onlays use e-max press to restore defective restored molar with old restoration or caries. with one or more cusp defect
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| onlays conservative | Experimental | Other: onlays conservativeconservative onlays preparation with partial cusp coverage only defective cusps |
| onlays conventional | Active comparator | Other: onlays conventionalonlays preparation design conventional as all cusps covered with shoulder finish line preparation |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 1-From 18-50 years old, be able to read and sign the informed consent document. 2- Have no active periodontal or pulpal diseases, have teeth with good restorations 3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for onlay restoration:
- Decayed teeth
- Teeth restored with defected filling restorations
- Teeth with occlusal defect 5- Able to return for follow-up examinations and evaluation Exclusion criteria
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| onlays conservativePartial coverage of cusps with shoulder finish line | Other | onlays conservative |
| onlays conventionalall coverage of cusps as overlay with shoulder finish line | Other | onlays conventional |
Primary outcome
evaluation of fracture resistance
Time frame: one year
fracture resistance of restorations postoperatively: assessment of the restoration for fracture resistance , by using Measuring device Modified United States Public Health Service (MUSPHS) parameters were used to compare the restorations at baseline and final examination use explorer Measuring unit .Discrete(scores) 1. alpha no evidence of fracture 2. bravo evidence of fracture
2 secondary outcomes
evaluation of marginal adaptation
Time frame: 1 year
evaluation of patient satisfaction to the onlay restoration through questioning the patient about pain during eating , acceptability ,sensitivity
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 22 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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.
Eman Hussein contact
Questions about this trial
What is this clinical trial studying?
A study testing onlays conservative and onlays conventional in people with Tooth Decay, 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 14 inclusion and 0 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 22 Feb 2022. 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 Howaida Elhagrasy, M.D.S (01006890707, howayda.elhagrasy@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of fracture resistance (time frame: one 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 22 Feb 2022.