Dental CariesNCT07648485
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
A study testing hybrid ceramics and Composite resin in people with Dental Caries and Cavity, Dental, run by Cairo University.
Trial summary
this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Dental Caries, Cavity, Dental, Proximal Dental Caries
- What is being tested?
- hybrid ceramics and Composite resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Nov 2028
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Systematically healthy male or female subjects aged 16 to 50 years.
- Patients with good oral hygiene.
- Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
- Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
- Presence of functional opposing teeth in stable occlusion
Who cannot join
- Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
- Current pregnancy or lactation.
- Documented allergy to resin-based composites or adhesive systems.
- Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
- Presence of cracks or fractures involving the tooth structure.
- Active localized or generalized periodontal disease.
- Evidence of parafunctional habits, including bruxism or clenching.
- High caries risk.
About this study
Official title: Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial
this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.
Read the detailed description
A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.
Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.
Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.
- Conditions
- Dental Caries, Cavity, Dental, Proximal Dental Caries
- Being tested
- hybrid ceramics, Composite resin
- Keywords
- indirect restoration, CAD/CAM, clinical performance, inlay, hybrid ceramics
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid ceramicsOther
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group.
Composite resinOther
after caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid ceramic group | Experimental | indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks Receives: Other: hybrid ceramics |
| Composite Resin group | Active comparator | indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks Receives: Other: Composite resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Adaptation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
Secondary outcomes (6)
color match
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
marginal discoloration
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
aesthetic anatomic form
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
recurrent caries
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
restoration fracture
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
Post-operative hypersensitivity
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
Measured: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Ahmed Sayed Karim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648485
- Sponsor's protocol ID
- CairoU-Hybrid Ceramic Inlays
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tennert C, Maliakal C, Suarez Machado L, Jaeggi T, Meyer-Lueckel H, Wierichs Richard J. Longevity of posterior direct versus indirect composite restorations: A systematic review and meta-analysis. Dent Mater. 2024 Nov;40(11):e95-e101. doi: 10.1016/j.dental.2024.07.033. Epub 2024 Aug 9.
PubMed 39122602Hassan A, Hamdi K, Ali AI, Al-Zordk W, Mahmoud SH. Clinical performance comparison between lithium disilicate and hybrid resin nano-ceramic CAD/CAM onlay restorations: a two-year randomized clinical split-mouth study. Odontology. 2024 Apr;112(2):601-615. doi: 10.1007/s10266-023-00841-w. Epub 2023 Aug 5.
PubMed 37542639Fathy H, Hamama HH, El-Wassefy N, Mahmoud SH. Clinical performance of resin-matrix ceramic partial coverage restorations: a systematic review. Clin Oral Investig. 2022 May;26(5):3807-3822. doi: 10.1007/s00784-022-04449-2. Epub 2022 Mar 23.
PubMed 35320383Coskun E, Aslan YU, Ozkan YK. Evaluation of two different CAD-CAM inlay-onlays in a split-mouth study: 2-year clinical follow-up. J Esthet Restor Dent. 2020 Mar;32(2):244-250. doi: 10.1111/jerd.12541. Epub 2019 Oct 23.
PubMed 31642587
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07648485
- Acronym / sponsor ID
- CairoU-Hybrid Ceramic Inlays
- Conditions
- Dental Caries, Cavity, Dental, Proximal Dental Caries
- Keywords
- indirect restoration, CAD/CAM, clinical performance, inlay, hybrid ceramics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 15 Jun 2026 (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 aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.
Detailed description
A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.
Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.
Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid ceramic group | Experimental | Other: hybrid ceramicsindirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks |
| Composite Resin group | Active comparator | Other: Composite resinindirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Systematically healthy male or female subjects aged 16 to 50 years.
- Patients with good oral hygiene.
- Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
- Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
- Presence of functional opposing teeth in stable occlusion
Key exclusion criteria (8 listed)
- Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
- Current pregnancy or lactation.
- Documented allergy to resin-based composites or adhesive systems.
- Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
- Presence of cracks or fractures involving the tooth structure.
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 |
|---|---|---|
| hybrid ceramicsafter caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Hard Hybrid Ceramic Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. SHOFU HC Primer will be applied to the hybrid-ceramic group. | Other | Hybrid ceramic group |
| Composite resinafter caries removal, inlay cavity preparation and immediate dentin sealing, the cavities were scanned using intraoral scanner and the restoration designed and milled using Composite Resin Blocks. the intaglio surface was air-abraded with 50 μm Al2O3 for 10-15 seconds. | Other | Composite Resin group |
Primary outcome
Marginal Adaptation
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).
6 secondary outcomes
color match
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
marginal discoloration
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
aesthetic anatomic form
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
recurrent caries
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
restoration fracture
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
Post-operative hypersensitivity
Time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation
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 28 Oct 2026.
- Background: PubMed 39122602Tennert C, Maliakal C, Suarez Machado L, Jaeggi T, Meyer-Lueckel H, Wierichs Richard J. Longevity of posterior direct versus indirect composite restorations: A systematic review and meta-analysis. Dent Mater. 2024 Nov;40(11):e95-e101. doi: 10.1016/j.dental.2024.07.033. Epub 2024 Aug 9.
- Background: PubMed 37542639Hassan A, Hamdi K, Ali AI, Al-Zordk W, Mahmoud SH. Clinical performance comparison between lithium disilicate and hybrid resin nano-ceramic CAD/CAM onlay restorations: a two-year randomized clinical split-mouth study. Odontology. 2024 Apr;112(2):601-615. doi: 10.1007/s10266-023-00841-w. Epub 2023 Aug 5.
- Background: PubMed 35320383Fathy H, Hamama HH, El-Wassefy N, Mahmoud SH. Clinical performance of resin-matrix ceramic partial coverage restorations: a systematic review. Clin Oral Investig. 2022 May;26(5):3807-3822. doi: 10.1007/s00784-022-04449-2. Epub 2022 Mar 23.
- Background: PubMed 31642587Coskun E, Aslan YU, Ozkan YK. Evaluation of two different CAD-CAM inlay-onlays in a split-mouth study: 2-year clinical follow-up. J Esthet Restor Dent. 2020 Mar;32(2):244-250. doi: 10.1111/jerd.12541. Epub 2019 Oct 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing hybrid ceramics and Composite resin in people with Dental Caries and Cavity, Dental, 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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?
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?
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?
Marginal Adaptation (time frame: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07648485, which also lists 4 linked publications.
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 28 Oct 2026.