Dental CariesNCT06155773
Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)
A study testing Highly viscous glass ionomer (cervical margin relocation), Low shrinkage Flowable Composite (cervical margin relocation) and Resin Modified Glass Ionomer (cervical margin relocation) in people with Dental Caries, run by Mansoura University at 1 site in Egypt.
Trial summary
The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Highly viscous glass ionomer (cervical margin relocation), Low shrinkage Flowable Composite (cervical margin relocation) and Resin Modified Glass Ionomer (cervical margin relocation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Aug 2021to Jan 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general health
- Good oral hygiene
- Patient aging 20-40 y
- Patients with proximal deep carious lesion
- International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
- Normal response to a vitality test.
Who cannot join
- poor general health
- poor oral hygiene
- Teeth would need direct pulp capping
- Teeth act as abutment for fixed or removable prosthesis.
- patients with excessive parafunctional habits
- Patient potentially unable to be compliant to recall visits
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry , Mansoura University
Al Mansurah, Dakahlia Governorate
About this study
Official title: Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations
The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.
- Conditions
- Dental Caries
- Being tested
- Highly viscous glass ionomer (cervical margin relocation), Low shrinkage Flowable Composite (cervical margin relocation), Resin Modified Glass Ionomer (cervical margin relocation), Bioactive Ionic Resin (cervical margin relocation)
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Highly viscous glass ionomer (cervical margin relocation)Procedure or surgery
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Low shrinkage Flowable Composite (cervical margin relocation)Procedure or surgery
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Resin Modified Glass Ionomer (cervical margin relocation)Procedure or surgery
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
Bioactive Ionic Resin (cervical margin relocation)Procedure or surgery
different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations
| Study group | Role | What they receive |
|---|---|---|
| Highly viscous Glass Ionomer | Experimental | Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration Receives: Procedure: Highly viscous glass ionomer (cervical margin relocation) |
| Low shrinkage Flowable Composite | Experimental | Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration Receives: Procedure: Low shrinkage Flowable Composite (cervical margin relocation) |
| Resin Modified Glass Ionomer | Experimental | Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration Receives: Procedure: Resin Modified Glass Ionomer (cervical margin relocation) |
| Bioactive Ionic Resin | Experimental | Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration Receives: Procedure: Bioactive Ionic Resin (cervical margin relocation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingiva
Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva
Measured: three year follow up
Modified World Dental Federation (FDI) clinical Criteria
- Functional Properties of restorations:
- Fracture of material and retention
- Marginal adaptation
- Radiographic examination
- Biological Properties of restorations
- Postoperative (hyper-sensitivity and tooth vitality
- Recurrence of caries
- Tooth integrity (enamel cracks, tooth fractures)
- Periodontal Response
- Adjacent mucosa
Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor.
Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated
Measured: three year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start24 Aug 2021
- Primary completion5 Jan 2022
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155773
- Sponsor's protocol ID
- 9153193
- Status last verified
- May 2023
- First submitted
- 17 Oct 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations
- ClinicalTrials.gov ID
- NCT06155773
- Acronym / sponsor ID
- 9153193
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- Jan 2025 (estimated)
- First posted
- 4 Dec 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 current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Highly viscous Glass Ionomer | Experimental | Procedure: Highly viscous glass ionomer (cervical margin relocation)Highly viscous glass ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration |
| Low shrinkage Flowable Composite | Experimental | Procedure: Low shrinkage Flowable Composite (cervical margin relocation)Low shrinkage Flowable Composite restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration |
| Resin Modified Glass Ionomer | Experimental | Procedure: Resin Modified Glass Ionomer (cervical margin relocation)Resin Modified Glass Ionomer restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration |
| Bioactive Ionic Resin | Experimental | Procedure: Bioactive Ionic Resin (cervical margin relocation)Bioactive Ionic Resin restoration is used to elevate the subgingival cervical margin in deep class II cavities before receiving cad/cam onlay restoration |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Good general health
- Good oral hygiene
- Patient aging 20-40 y
- Patients with proximal deep carious lesion
- International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
Key exclusion criteria (6 listed)
- poor general health
- poor oral hygiene
- Teeth would need direct pulp capping
- Teeth act as abutment for fixed or removable prosthesis.
- patients with excessive 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 |
|---|---|---|
| Highly viscous glass ionomer (cervical margin relocation)different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations | Procedure or surgery | Highly viscous Glass Ionomer |
| Low shrinkage Flowable Composite (cervical margin relocation)different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations | Procedure or surgery | Low shrinkage Flowable Composite |
| Resin Modified Glass Ionomer (cervical margin relocation)different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations | Procedure or surgery | Resin Modified Glass Ionomer |
| Bioactive Ionic Resin (cervical margin relocation)different dental restorative materials used to relocate deep cervical margins before receiving onlay restorations | Procedure or surgery | Bioactive Ionic Resin |
Primary outcome
Gingiva
Time frame: three year follow up
Gingival Index Scale from 0 to 3 will be used for evaluation considering that score 0 represents normal gigiva while score 3 represents severely inflamed gingiva
Modified World Dental Federation (FDI) clinical Criteria
Time frame: three year follow up
1. Functional Properties of restorations: 1. Fracture of material and retention 2. Marginal adaptation 3. Radiographic examination 2. Biological Properties of restorations 1. Postoperative (hyper-sensitivity and tooth vitality 2. Recurrence of caries 3. Tooth integrity (enamel cracks, tooth fractures) 4. Periodontal Response 5. Adjacent mucosa Descriptive scale from 1 to 5. Note: 1 is clinically excellent 5 is clinically poor. Scores(1-3) are considered sufficient The overall cumulative success rate of restorations will be evaluated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Highly viscous glass ionomer (cervical margin relocation), Low shrinkage Flowable Composite (cervical margin relocation) and Resin Modified Glass Ionomer (cervical margin relocation) in people with Dental Caries, 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 6 inclusion and 6 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 8 Dec 2023. 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?
Results are not available in the source record.
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?
Gingiva (time frame: three year follow up). The study lists 2 primary outcomes in all. 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 8 Dec 2023.