InlaysNCT05978440
This Trial Will Evaluate the Clinical Performance of Onlay Restorations Fabricated Using Rubber Dam Scanning Techniques.
A study testing onlay preparation in people with Inlays, run by Alexandria University.
Trial summary
The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory investigation of their marginal fit. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inlays
- What is being tested?
- onlay preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2023to 30 Dec 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult patients (18-45 years old).
- Patients in need of class II (OM or OD) caries in molar teeth with initial, moderate or extensive stage according to the staging of caries lesions in The International Caries Detection and Assessment system (ICDASTM codes 2 to 6) (32,33).
- Presence of proximal caries in digital x-ray with score 2 to 4 according to the ICDAS/ICCMS™ radiographic scoring system(32,33).
- Vital teeth with absence of clinical signs and symptoms of periapical pathology.
- Patient Ability to tolerate Rubber Dam applications.
- Patients who will agree to attend regular check-ups.
Who cannot join
- Bad oral hygiene (Grade 3)(34).
- Non- vital teeth or endodontically treated teeth.
- Severe Periodontal problems (pockets ≥6mm).
- Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)
Trial locations and contacts
No sites are listed yet.
-1-*Rania R Afifi contact
About this study
Official title: Clinical and Laboratory Evaluation of Cad-cam Restorations Fabricated From Digital Impression Under Rubber Dam Isolation (Randomized Clinical Trial & In-vitro Study)
The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory investigation of their marginal fit.
Read the detailed description
A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will be divided into three groups according to the technique of scanning. Group I: 18 preparations will be scanned without rubber dam using standard technique, group II: 18 preparations will be scanned under rubber dam isolation using cut technique, and group III: 18 preparations will be scanned under rubber dam isolation using lock technique. Final restorations will be milled, checked and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for onlay. The dies will be scanned after they fit in a typodont and grouped with the same technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit alignment method and 3D deviation will be calculated for each group itself and to the other groups. The marginal fit of the restorations produced will be checked using two methods: Triple scan and measuring the cement thickness after cementation and sectioning of the samples.
All data will be collected, and statistically analyzed using suitable tests.
- Conditions
- Inlays
- Being tested
- onlay preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
onlay preparationProcedure or surgery
CAD-CAM onlay restorations will be fabricated using rubber dam scanning techniques and evaluated clinically up to 12 months
| Study group | Role | What they receive |
|---|---|---|
| Scanning without rubber dam | Active comparator | After the onlay preparation, standard digital impression will be recorded for the working quadrant using the IOS without applying the rubber dam. Then the opposing quadrant will be scanned in addition to interocclusal bite registration. Receives: Procedure: onlay preparation |
| Scanning under rubber dam with cut technique | Experimental | In this group a pre-operative scan will be already taken before the preparation for the working arch, opposing arch and the interocclusal bite registration. Then using the "Cut" feature in the software of the IOS to cut the area of the working tooth. After the preparation, rubber dam will be applied on the working quadrant and then rescan the prepared tooth. Receives: Procedure: onlay preparation |
| Scanning under rubber dam with new lock technique | Experimental | After the onlay preparation, the rubber dam will be applied to the working quadrant. Digital impression will be taken using the IOS. After that using the "lock" feature in the software of the scanner, all the preparation area and margins will be locked. Rubber dam will be removed, and scanning will be completed for the whole quadrant and opposing arch in addition to interocclusal bite registration. Receives: Procedure: onlay preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.
Restorations will be evaluated according to three main domains: (40)
- Functional (domain F): fracture of material and retention(F1), marginal adaptation(F2), proximal contact point(F3), Form and contour(F4), and Occlusion and wear(F5).
- Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3).
- Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).
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 posted7 Aug 2023
- Study start25 Jul 2023 (estimated)
- Primary completion25 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InlaysStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hossam m kamel, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978440
- Sponsor's protocol ID
- 0682-05/2023 IRB 00010556
- Other IDs
- IRB 00010556
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Evaluation of Cad-cam Restorations Fabricated From Digital Impression Under Rubber Dam Isolation (Randomized Clinical Trial & In-vitro Study)
- ClinicalTrials.gov ID
- NCT05978440
- Acronym / sponsor ID
- 0682-05/2023 IRB 00010556
- Conditions
- Inlays
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Aug 2023 (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 purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory investigation of their marginal fit.
Detailed description
A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will be divided into three groups according to the technique of scanning. Group I: 18 preparations will be scanned without rubber dam using standard technique, group II: 18 preparations will be scanned under rubber dam isolation using cut technique, and group III: 18 preparations will be scanned under rubber dam isolation using lock technique. Final restorations will be milled, checked and cemented, then will be evaluated using the modified FDI criteria at baseline, three months, six months, and one year.
Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for onlay. The dies will be scanned after they fit in a typodont and grouped with the same technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit alignment method and 3D deviation will be calculated for each group itself and to the other groups. The marginal fit of the restorations produced will be checked using two methods: Triple scan and measuring the cement thickness after cementation and sectioning of the samples.
All data will be collected, and statistically analyzed using suitable tests.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scanning without rubber dam | Active comparator | Procedure: onlay preparationAfter the onlay preparation, standard digital impression will be recorded for the working quadrant using the IOS without applying the rubber dam. Then the opposing quadrant will be scanned in addition to interocclusal bite registration. |
| Scanning under rubber dam with cut technique | Experimental | Procedure: onlay preparationIn this group a pre-operative scan will be already taken before the preparation for the working arch, opposing arch and the interocclusal bite registration. Then using the "Cut" feature in the software of the IOS to cut the area of the working tooth. After the preparation, rubber dam will be applied on the working quadrant and then rescan the prepared tooth. |
| Scanning under rubber dam with new lock technique | Experimental | Procedure: onlay preparationAfter the onlay preparation, the rubber dam will be applied to the working quadrant. Digital impression will be taken using the IOS. After that using the "lock" feature in the software of the scanner, all the preparation area and margins will be locked. Rubber dam will be removed, and scanning will be completed for the whole quadrant and opposing arch in addition to interocclusal bite registration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult patients (18-45 years old).
- Patients in need of class II (OM or OD) caries in molar teeth with initial, moderate or extensive stage according to the staging of caries lesions in The International Caries Detection and Assessment system (ICDASTM codes 2 to 6) (32,33).
- Presence of proximal caries in digital x-ray with score 2 to 4 according to the ICDAS/ICCMS™ radiographic scoring system(32,33).
- Vital teeth with absence of clinical signs and symptoms of periapical pathology.
- Patient Ability to tolerate Rubber Dam applications.
Key exclusion criteria (4 listed)
- Bad oral hygiene (Grade 3)(34).
- Non- vital teeth or endodontically treated teeth.
- Severe Periodontal problems (pockets ≥6mm).
- Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)
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 |
|---|---|---|
| onlay preparationCAD-CAM onlay restorations will be fabricated using rubber dam scanning techniques and evaluated clinically up to 12 months | Procedure or surgery | Scanning under rubber dam with cut technique, Scanning under rubber dam with new lock technique, Scanning without rubber dam |
Primary outcome
Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.
Time frame: 12 months
Restorations will be evaluated according to three main domains: (40) 1. Functional (domain F): fracture of material and retention(F1), marginal adaptation(F2), proximal contact point(F3), Form and contour(F4), and Occlusion and wear(F5). 2. Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3). 3. Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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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-*Rania R Afifi contact
hossam m kamel study chair
Alexandria University
Questions about this trial
What is this clinical trial studying?
A study testing onlay preparation in people with Inlays, run by Alexandria 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 6 inclusion and 4 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 7 Aug 2023. 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 hossam M kamel (012858734310 ext. +2, hosam.kamel@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning. (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 7 Aug 2023.