Indirect Tooth-colored Onlay Restorations in Posterior TeethNCT07157410
Clinical Evaluation of Indirect Tooth-Colored Onlays With Cervical Margin Relocation
A study testing Machinable lithium-disilicate ceramic onlay (IPS e.max CAD), Pressed lithium-disilicate ceramic onlay (IPS e.max Press) and Machinable composite onlay (BRILLIANT Crios) in people with Indirect Tooth-colored Onlay Restorations in Posterior Teeth and Clinical Performance of Cervical-margin-relocated Onlay Restorations, run by Mansoura University at 1 site in Egypt.
Trial summary
This study will evaluate the performance of three different tooth-colored onlay materials in adult patients' posterior teeth. First, investigators will use a bulk-fill composite resin to raise the cavity margin above the gum line and below the contact point. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Indirect Tooth-colored Onlay Restorations in Posterior Teeth, Clinical Performance of Cervical-margin-relocated Onlay Restorations
- What is being tested?
- Machinable lithium-disilicate ceramic onlay (IPS e.max CAD), Pressed lithium-disilicate ceramic onlay (IPS e.max Press) and Machinable composite onlay (BRILLIANT Crios)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Molar tooth with proximal subgingival carious lesion of ICDAS 4 or 5, causing weakening of one or more cusps.
- Normal alignment with the adjacent and opposing teeth.
- Acceptance of the follow-up period and recall visits for 2 years.
Who cannot join
- Distance between the gingival margin and the crestal bone < 2 mm.
- The tooth would require direct pulp capping.
- Poor oral hygiene (or not completing the oral hygiene phase).
- Chronic periodontitis.
- Pulpitis or non-vital tooth.
- Orthodontic treatment.
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- Parafunctional habits.
- Systemic disease.
- Pregnancy.
- Teeth act as abutment for fixed or removable prosthesis.
- Occlusion of fewer than 20 teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Ali Ihsan AlQurashi, +9647813003774, ali1ihsan93@gmail.com
About this study
Official title: Two-year Clinical Evaluation of Different Indirect Tooth-colored Onlay Restorations Placed in Posterior Teeth With Cervical Margin Relocation and Laboratory Investigation of Marginal Adaptation
This study will evaluate the performance of three different tooth-colored onlay materials in adult patients' posterior teeth. First, investigators will use a bulk-fill composite resin to raise the cavity margin above the gum line and below the contact point. Then each patient will receive three onlays made from different materials. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess how well the onlays fit, function, and whether restorations cause sensitivity or new decay. The results will help dentists choose the most durable onlay restorations for deep-margin elevation cases.
- Conditions
- Indirect Tooth-colored Onlay Restorations in Posterior Teeth, Clinical Performance of Cervical-margin-relocated Onlay Restorations
- Being tested
- Machinable lithium-disilicate ceramic onlay (IPS e.max CAD), Pressed lithium-disilicate ceramic onlay (IPS e.max Press), Machinable composite onlay (BRILLIANT Crios)
- Keywords
- cervical margin relocation, marginal adaptation, Indirect onlay restorations, Lithium-disilicate, CAD/CAM composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)Other
Single indirect onlay restoration milled from an IPS e.max CAD block and crystallized according to the manufacturer's Instructions for Use, then adhesively luted on a randomized molar under.
Pressed lithium-disilicate ceramic onlay (IPS e.max Press)Other
Single indirect onlay restoration heat-pressed from an IPS e.max Press ingot and then adhesively luted on a randomized molar under rubber-dam isolation.
Machinable composite onlay (BRILLIANT Crios)Other
Single indirect onlay restoration milled from a BRILLIANT Crios block and then adhesively luted on a randomized molar under rubber-dam isolation.
| Study group | Role | What they receive |
|---|---|---|
| Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) | Experimental | Each participant contributes one randomized molar restored with a machinable lithium-disilicate onlay (IPS e.max CAD). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. Receives: Other: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) |
| Pressed lithium-disilicate ceramic onlay (IPS e.max Press) | Experimental | Each participant contributes one randomized molar restored with a pressed lithium-disilicate onlay (IPS e.max Press). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. Receives: Other: Pressed lithium-disilicate ceramic onlay (IPS e.max Press) |
| Machinable composite onlay (BRILLIANT Crios) | Experimental | Each participant contributes one randomized molar restored with a machinable composite onlay (BRILLIANT Crios). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. Receives: Other: Machinable composite onlay (BRILLIANT Crios) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
Each onlay will be scored per the Revised 2023 World Dental Federation (FDI) criteria across the specified domains (F1, F2, B1, B2, B3, M2). Outcomes will be summarized as (a) mean (SD) score for each domain, and (b) proportion of restorations rated 1-3 (clinically acceptable) vs 4-5 for each domain. Lower scores indicate better clinical performance.
Measured: Post-cementation baseline (2 weeks), 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start14 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Tooth-colored Onlay Restorations in Posterior TeethStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Model description
- Split-mouth randomized allocation at the tooth level (each participant receives three onlays, one per material).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157410
- Sponsor's protocol ID
- A0502025CD
- Status last verified
- Mar 2025
- First submitted
- 5 May 2025
- Last updated
- 5 Sep 2025
- 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 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-year Clinical Evaluation of Different Indirect Tooth-colored Onlay Restorations Placed in Posterior Teeth With Cervical Margin Relocation and Laboratory Investigation of Marginal Adaptation
- ClinicalTrials.gov ID
- NCT07157410
- Acronym / sponsor ID
- A0502025CD
- Conditions
- Indirect Tooth-colored Onlay Restorations in Posterior Teeth, Clinical Performance of Cervical-margin-relocated Onlay Restorations
- Keywords
- cervical margin relocation, marginal adaptation, Indirect onlay restorations, Lithium-disilicate, CAD/CAM composite
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
This study will evaluate the performance of three different tooth-colored onlay materials in adult patients' posterior teeth. First, investigators will use a bulk-fill composite resin to raise the cavity margin above the gum line and below the contact point. Then each patient will receive three onlays made from different materials. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess how well the onlays fit, function, and whether restorations cause sensitivity or new decay. The results will help dentists choose the most durable onlay restorations for deep-margin elevation cases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Split-mouth randomized allocation at the tooth level (each participant receives three onlays, one per material).
| Arm | Type | Receives |
|---|---|---|
| Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) | Experimental | Other: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)Each participant contributes one randomized molar restored with a machinable lithium-disilicate onlay (IPS e.max CAD). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. |
| Pressed lithium-disilicate ceramic onlay (IPS e.max Press) | Experimental | Other: Pressed lithium-disilicate ceramic onlay (IPS e.max Press)Each participant contributes one randomized molar restored with a pressed lithium-disilicate onlay (IPS e.max Press). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. |
| Machinable composite onlay (BRILLIANT Crios) | Experimental | Other: Machinable composite onlay (BRILLIANT Crios)Each participant contributes one randomized molar restored with a machinable composite onlay (BRILLIANT Crios). Adhesive luting is performed under rubber-dam isolation using the standardized protocol. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Molar tooth with proximal subgingival carious lesion of ICDAS 4 or 5, causing weakening of one or more cusps.
- Normal alignment with the adjacent and opposing teeth.
- Acceptance of the follow-up period and recall visits for 2 years.
Key exclusion criteria (11 listed)
- Distance between the gingival margin and the crestal bone < 2 mm.
- The tooth would require direct pulp capping.
- Poor oral hygiene (or not completing the oral hygiene phase).
- Chronic periodontitis.
- Pulpitis or non-vital tooth.
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 |
|---|---|---|
| Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)Single indirect onlay restoration milled from an IPS e.max CAD block and crystallized according to the manufacturer's Instructions for Use, then adhesively luted on a randomized molar under. | Other | Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) |
| Pressed lithium-disilicate ceramic onlay (IPS e.max Press)Single indirect onlay restoration heat-pressed from an IPS e.max Press ingot and then adhesively luted on a randomized molar under rubber-dam isolation. | Other | Pressed lithium-disilicate ceramic onlay (IPS e.max Press) |
| Machinable composite onlay (BRILLIANT Crios)Single indirect onlay restoration milled from a BRILLIANT Crios block and then adhesively luted on a randomized molar under rubber-dam isolation. | Other | Machinable composite onlay (BRILLIANT Crios) |
Primary outcome
FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
Time frame: Post-cementation baseline (2 weeks), 6, 12, 18, and 24 months
Each onlay will be scored per the Revised 2023 World Dental Federation (FDI) criteria across the specified domains (F1, F2, B1, B2, B3, M2). Outcomes will be summarized as (a) mean (SD) score for each domain, and (b) proportion of restorations rated 1-3 (clinically acceptable) vs 4-5 for each domain. Lower scores indicate better clinical performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Machinable lithium-disilicate ceramic onlay (IPS e.max CAD), Pressed lithium-disilicate ceramic onlay (IPS e.max Press) and Machinable composite onlay (BRILLIANT Crios) in people with Indirect Tooth-colored Onlay Restorations in Posterior Teeth and Clinical Performance of Cervical-margin-relocated Onlay Restorations, run by Mansoura University at 1 site in Egypt.
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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Ihsan AlQurashi (+9647813003774, ali1ihsan93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains. (time frame: Post-cementation baseline (2 weeks), 6, 12, 18, and 24 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 5 Sep 2025.