Clinical PerformanceNCT07667946
Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars
A study testing Anatomical cavity design preparation and Butt joint cavity design preparation in people with Clinical Performance, run by Cairo University.
Trial summary
This randomized clinical trial aims to evaluate the effect of different cavity designs on the clinical performance of 3D-printed resin composite partial-coverage restorations in vital molars with complex cavities over an 18-month follow-up period. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Clinical Performance
- What is being tested?
- Anatomical cavity design preparation and Butt joint cavity design preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aging 20-45 years.
- Healthy males and females
- Patients with good oral hygiene
- Patients presenting with at least one eligible permanent molar requiring a partial-coverage restoration.
- Patients willing and able to attend scheduled follow-up visits for 18 months.
- Permanent maxillary or mandibular molars.
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- Vital teeth with a positive response to cold thermal testing.
- Complex Large or severely compromised cavities resulting from primary or secondary caries (ICDAS 5 or 6) and/or replacement of large defective restorations with at least 2 missing cavity walls requiring overlay restorations
- Well-formed and fully erupted in normal functional occlusion with natural antagonist and adjacent teeth.
- Absence of any radiographic, periodontal or periapical changes.
Who cannot join
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability or unwillingness to comply with study visits and procedures.
- Heavy bruxism or other parafunctional habits
- Known allergic reactions against any components of the used materials
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- Patients receiving orthodontic treatment.
- Poor oral hygiene or high caries activity.
- Non vital teeth.
- Hypersensitive teeth.
- Teeth with prior endodontic treatment.
- Teeth with spontaneous pain or signs/symptoms of irreversible pulpitis.
- Teeth with advanced periodontal disease or mobility.
- Teeth with a history of direct or indirect pulp capping procedure.
- Teeth with vertical root fractures or cracked tooth syndrome
About this study
Official title: Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars With Complex Cavities: An 18 Month Randomized Clinical Trial
This randomized clinical trial aims to evaluate the effect of different cavity designs on the clinical performance of 3D-printed resin composite partial-coverage restorations in vital molars with complex cavities over an 18-month follow-up period.
Read the detailed description
Despite these material advancements, growing evidence indicates that cavity preparation design exerts a greater influence on the clinical performance of indirect restorations than material selection alone. However, current evidence regarding preparation design is predominantly derived from in vitro studies and remains inadequately validated under clinical conditions, particularly in vital molars. Although recent randomized clinical trials have begun to address this gap, available data remain limited and largely confined to endodontically treated teeth. Therefore, a rigorously designed randomized clinical trial is warranted to evaluate the influence of different cavity preparation designs on the clinical performance of indirect restorations in vital molars.
- Conditions
- Clinical Performance
- Being tested
- Anatomical cavity design preparation, Butt joint cavity design preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical cavity design preparationProcedure or surgery
Cavity preparation design for adhesive restoration
Butt joint cavity design preparationProcedure or surgery
Cavity preparation design for adhesive restoration
| Study group | Role | What they receive |
|---|---|---|
| Anatomical cavity design preparation | Experimental | Following caries excavation and removal of defective restorations, cavity preparations will be carried out according to the accepted principles of adhesive overlays. The cavity walls will be prepared with 6-12° internal axial wall divergence using blue-coded tapered round-end diamond burs (Komet, USA) and subsequently finished using extra-fine yellow-coded tapered round-end diamond burs (#368EF, Komet, USA). The thickness of potentially maintainable cusps will be assessed using a dental caliper (Diamonds Surgical Instruments, Pakistan). Weakened or undermined cusps (less than 2 mm thickness) will be reduced using the same diamond burs to create an anatomical occlusal reduction following the natural tooth morphology, with a reduction of 2 mm. Receives: Procedure: Anatomical cavity design preparation |
| Butt joint cavity design preparation | Active comparator | The cavity walls will be prepared with 6-12° internal axial wall divergence using blue-coded tapered round-end diamond burs (Komet, USA) and subsequently finished using extra-fine yellow-coded tapered round-end diamond burs (#368EF, Komet, USA). The thickness of potentially maintainable cusps will be assessed using a dental caliper (Diamonds Surgical Instruments, Pakistan). The occlusal reduction design, where weakened or undermined cusps will be reduced using a wheel stone (#909, Komet, USA) to create a flat butt-joint occlusal design with a uniform occlusal reduction of 2 mm. Additional reduction will be performed when necessary, and the available interocclusal clearance will be verified using a graduated periodontal probe in maximum intercuspation and eccentric movements. Receives: Procedure: Butt joint cavity design preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fracture
Modified USPHS Ryge Criteria (Ordinal scoring system)
Measured: 18 Months
Secondary outcomes (1)
Retention, marginal integrity, marginal discoloration, wear/anatomic form, secondary caries and surface texture
Modified USPHS Ryge Criteria (Ordinal scoring system)
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical PerformanceStudies 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
- Model description
- Randomized clinical trial (RCT), triple blinded, parallel groups, two arms, superiority study with 1:1 allocation ratio.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilly Assem Mousa Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667946
- Sponsor's protocol ID
- Effect of Cavity Designs
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars With Complex Cavities: An 18 Month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07667946
- Acronym / sponsor ID
- Effect of Cavity Designs
- Conditions
- Clinical Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 25 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 randomized clinical trial aims to evaluate the effect of different cavity designs on the clinical performance of 3D-printed resin composite partial-coverage restorations in vital molars with complex cavities over an 18-month follow-up period.
Detailed description
Despite these material advancements, growing evidence indicates that cavity preparation design exerts a greater influence on the clinical performance of indirect restorations than material selection alone. However, current evidence regarding preparation design is predominantly derived from in vitro studies and remains inadequately validated under clinical conditions, particularly in vital molars. Although recent randomized clinical trials have begun to address this gap, available data remain limited and largely confined to endodontically treated teeth. Therefore, a rigorously designed randomized clinical trial is warranted to evaluate the influence of different cavity preparation designs on the clinical performance of indirect restorations in vital molars.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial (RCT), triple blinded, parallel groups, two arms, superiority study with 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Anatomical cavity design preparation | Experimental | Procedure: Anatomical cavity design preparationFollowing caries excavation and removal of defective restorations, cavity preparations will be carried out according to the accepted principles of adhesive overlays. The cavity walls will be prepared with 6-12° internal axial wall divergence using blue-coded tapered round-end diamond burs (Komet, USA) and subsequently finished using extra-fine yellow-coded tapered round-end diamond burs (#368EF, Komet, USA). The thickness of potentially maintainable cusps will be assessed using a dental caliper (Diamonds Surgical Instruments, Pakistan). Weakened or undermined cusps (less than 2 mm thickness) will be reduced using the same diamond burs to create an anatomical occlusal reduction following the natural tooth morphology, with a reduction of 2 mm. |
| Butt joint cavity design preparation | Active comparator | Procedure: Butt joint cavity design preparationThe cavity walls will be prepared with 6-12° internal axial wall divergence using blue-coded tapered round-end diamond burs (Komet, USA) and subsequently finished using extra-fine yellow-coded tapered round-end diamond burs (#368EF, Komet, USA). The thickness of potentially maintainable cusps will be assessed using a dental caliper (Diamonds Surgical Instruments, Pakistan). The occlusal reduction design, where weakened or undermined cusps will be reduced using a wheel stone (#909, Komet, USA) to create a flat butt-joint occlusal design with a uniform occlusal reduction of 2 mm. Additional reduction will be performed when necessary, and the available interocclusal clearance will be verified using a graduated periodontal probe in maximum intercuspation and eccentric movements. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult patients aging 20-45 years.
- Healthy males and females
- Patients with good oral hygiene
- Patients presenting with at least one eligible permanent molar requiring a partial-coverage restoration.
- Patients willing and able to attend scheduled follow-up visits for 18 months.
Key exclusion criteria (15 listed)
- Participants with general/systemic illness.
- Pregnant or lactating females.
- Concomitant participation in another research study.
- Inability or unwillingness to comply with study visits and procedures.
- Heavy bruxism or other parafunctional habits
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 |
|---|---|---|
| Anatomical cavity design preparationCavity preparation design for adhesive restoration | Procedure or surgery | Anatomical cavity design preparation |
| Butt joint cavity design preparationCavity preparation design for adhesive restoration | Procedure or surgery | Butt joint cavity design preparation |
Primary outcome
Fracture
Time frame: 18 Months
Modified USPHS Ryge Criteria (Ordinal scoring system)
1 secondary outcome
Retention, marginal integrity, marginal discoloration, wear/anatomic form, secondary caries and surface texture
Time frame: 18 Months
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 25 Jun 2026.
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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 Anatomical cavity design preparation and Butt joint cavity design preparation in people with Clinical Performance, 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 10 inclusion and 15 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 25 Jun 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?
Fracture (time frame: 18 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 25 Jun 2026.