Dental Restoration FailureNCT07265609
Clinical Performance of Two Different Resin-Matrix Ceramic Restorations
A study testing inlays in people with Dental Restoration Failure, run by Mansoura University at 1 site in Egypt.
Trial summary
This study was designed to evaluate and compare the 2-year clinical performance of two different resin-matrix ceramic inlays Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Restoration Failure
- What is being tested?
- inlays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Aug 2025
- 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
- The presence of two molars with compound proximal carious lesions or defective restorations involving two surfaces (occluso-mesial or occluso-distal cavities) corresponding to Black's Class II, with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS)
- The buccolingual width of lesions should exceed two-thirds of the intercuspal distance.
- The teeth were required to be vital and free from any periapical radiolucency.
- The teeth were required to be in normal alignment, in contact with sound adjacent teeth, and have antagonist teeth present in normal occlusion.
Who cannot join
- The presence of uncontrolled systemic disease, pregnancy or breastfeeding.
- Patients with extremely poor oral hygiene, active periodontal disease, or those involving in orthodontic treatment or periodontal surgery.
- Patients with wear facets and parafunctional habits as clinching and bruxism.
- Hypersensitive, endodontically treated, non-vital or cracked teeth.
- Teeth with proximal cavities involving more than two surfaces, those that exhibited pulp exposure during caries excavation and required direct pulp capping, or those with missing cusps necessitating cusp capping.
- Teeth without proximal contact, missing neighbouring or opposing teeth
- Patients with known unavailability to attend recall visits, or with known allergy to any component of the study materials.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahliya, 35516
About this study
Official title: A Two-year Comparative Evaluation of Clinical Performance of a CAD/CAM Composite to a Polymer-infiltrated Ceramic Restorations
This study was designed to evaluate and compare the 2-year clinical performance of two different resin-matrix ceramic inlays
Read the detailed description
The design of this prospective randomized controlled clinical trial was a split-mouth, two-arm, double-blinded clinical trial, with an allocation ratio of 1:1. The reporting of the trial followed the Consolidated Standards of Reporting Trials (CONSORT) Statement. Twelve adult patients seeking dental treatments in the Conservative Dentistry Department outpatient clinic, Faculty of Dentistry, Mansoura University, were enrolled in the current study with a total of twenty-four compound inlay cavities. Each patient must sign a consent form before participating in the current study. The study was conducted from August 2023 to August 2025 as a part of the doctoral dissertation. Mansoura University's institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated using the G*Power statistical program. Based on an effect size of 0.4, a significance level of 5% (p < 0.05), and a statistical power of 80%, a minimum of 10 samples per group was required. To compensate for potential dropouts, the total sample size was increased to 12 patients, yielding a total of 24 restorations.
- Conditions
- Dental Restoration Failure
- Being tested
- inlays
- Keywords
- Resin-matrix ceramics, Polymer-infiltrated ceramics, Resin nano-ceramics, Indirect restorations, CAD/CAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inlaysOther
Also called Indirect restorations, partial-coverage restorations
Inlay cavity preparations were performed, and RMC restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received one material on one side of the mouth and the other on the contralateral side. Side allocation was randomized.
| Study group | Role | What they receive |
|---|---|---|
| Resin nano-ceramic | Active comparator | Resin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized. Receives: Other: inlays |
| Polymer-infiltrated ceramics | Active comparator | Resin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized. Receives: Other: inlays |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esthetic, functional and biological properties for each CAD/CAM restorative material
Esthetic, functional and biological properties were assessed using World Dental Federation (FDI) criteria. Each criterion was rated on a five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.
Measured: 2 years
Secondary outcomes (2)
Radiographic examination
Each material was examined radiographically and radiographs were assessed and rated following World Dental Federation (FDI) five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.
Measured: 2 years
Periodontal response and adjacent mucosa
Periodontal responce and adjacent mucosa were assessed using World Dental Federation (FDI) criteria. Each criterion was rated on a five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Aug 2023
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Restoration FailureStudies 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
- The study is a randomized split-mouth clinical trial. Each participant received both restorative materials: a resin-nanoceramic and a polymer-infiltrated ceramic. Randomization assigned one material to one side of the mouth and the other material to the contralateral side for each participant. Treatments were applied according to the manufacturers' instructions.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanan Fathy, Assistant Lecturer, Principal investigator, Faculty of Dentistry, Mansoura University, EgyptHamdi Hamama, Clinical Professor, Study director, Faculty of Dentistry, Mansoura Universtity, EgyptJukka P Matinlinna, Clinical Professor, Study director, School of Medical Science, University of Manchester, M13 9PL, Manchester, UKSalah H Mahmoud, Clinical Professor, Study chair, Faculty of Dentistry, Mansoura Universtity, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265609
- Sponsor's protocol ID
- J0022055023CD
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-year Comparative Evaluation of Clinical Performance of a CAD/CAM Composite to a Polymer-infiltrated Ceramic Restorations
- ClinicalTrials.gov ID
- NCT07265609
- Acronym / sponsor ID
- J0022055023CD
- Conditions
- Dental Restoration Failure
- Keywords
- Resin-matrix ceramics, Polymer-infiltrated ceramics, Resin nano-ceramics, Indirect restorations, CAD/CAM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 5 Dec 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 was designed to evaluate and compare the 2-year clinical performance of two different resin-matrix ceramic inlays
Detailed description
The design of this prospective randomized controlled clinical trial was a split-mouth, two-arm, double-blinded clinical trial, with an allocation ratio of 1:1. The reporting of the trial followed the Consolidated Standards of Reporting Trials (CONSORT) Statement. Twelve adult patients seeking dental treatments in the Conservative Dentistry Department outpatient clinic, Faculty of Dentistry, Mansoura University, were enrolled in the current study with a total of twenty-four compound inlay cavities. Each patient must sign a consent form before participating in the current study. The study was conducted from August 2023 to August 2025 as a part of the doctoral dissertation. Mansoura University's institution's ethics committee approved the form and protocol before conducting the study. The sample size was calculated using the G*Power statistical program. Based on an effect size of 0.4, a significance level of 5% (p < 0.05), and a statistical power of 80%, a minimum of 10 samples per group was required. To compensate for potential dropouts, the total sample size was increased to 12 patients, yielding a total of 24 restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a randomized split-mouth clinical trial. Each participant received both restorative materials: a resin-nanoceramic and a polymer-infiltrated ceramic. Randomization assigned one material to one side of the mouth and the other material to the contralateral side for each participant. Treatments were applied according to the manufacturers' instructions.
| Arm | Type | Receives |
|---|---|---|
| Resin nano-ceramic | Active comparator | Other: inlaysResin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized. |
| Polymer-infiltrated ceramics | Active comparator | Other: inlaysResin-matrix ceramic CAD/CAM blocks for indirect restorations. Restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received this material on one side of the mouth; side allocation was randomized. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The presence of two molars with compound proximal carious lesions or defective restorations involving two surfaces (occluso-mesial or occluso-distal cavities) corresponding to Black's Class II, with a severity score of 4 or 5 according to the International Caries Detection and Assessment System (ICDAS)
- The buccolingual width of lesions should exceed two-thirds of the intercuspal distance.
- The teeth were required to be vital and free from any periapical radiolucency.
- The teeth were required to be in normal alignment, in contact with sound adjacent teeth, and have antagonist teeth present in normal occlusion.
Key exclusion criteria (7 listed)
- The presence of uncontrolled systemic disease, pregnancy or breastfeeding.
- Patients with extremely poor oral hygiene, active periodontal disease, or those involving in orthodontic treatment or periodontal surgery.
- Patients with wear facets and parafunctional habits as clinching and bruxism.
- Hypersensitive, endodontically treated, non-vital or cracked teeth.
- Teeth with proximal cavities involving more than two surfaces, those that exhibited pulp exposure during caries excavation and required direct pulp capping, or those with missing cusps necessitating cusp capping.
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 |
|---|---|---|
| inlaysAlso: Indirect restorations, partial-coverage restorationsInlay cavity preparations were performed, and RMC restorations were designed, milled, finished, and cemented on the assigned contralateral site according to the manufacturer's instructions. Each patient received one material on one side of the mouth and the other on the contralateral side. Side allocation was randomized. | Other | Polymer-infiltrated ceramics, Resin nano-ceramic |
Primary outcome
Esthetic, functional and biological properties for each CAD/CAM restorative material
Time frame: 2 years
Esthetic, functional and biological properties were assessed using World Dental Federation (FDI) criteria. Each criterion was rated on a five-point scale, where a score of 1 indicated clinically excellent or very good performance, score 2 indicated clinically good, score 3 indicated a clinically satisfactory, score 4 indicated clinically unsatisfactory, and score 5 indicated clinically poor performance requiring repair or replacement.
2 secondary outcomes
Radiographic examination
Time frame: 2 years
Periodontal response and adjacent mucosa
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes
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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.
Hanan Fathy, Assistant Lecturer principal investigator
Faculty of Dentistry, Mansoura University, Egypt
Hamdi Hamama, Clinical Professor study director
Faculty of Dentistry, Mansoura Universtity, Egypt
Jukka P Matinlinna, Clinical Professor study director
School of Medical Science, University of Manchester, M13 9PL, Manchester, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inlays in people with Dental Restoration Failure, 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 4 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: finished, as of the sponsor's last update on 5 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Esthetic, functional and biological properties for each CAD/CAM restorative material (time frame: 2 years). 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 Dec 2025.