Carious ToothNCT05431465
Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration
A study testing Vita Ambria and IPs emax onaly in people with Carious Tooth and Dental Wear, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA \& IPS e.max Press and their opposing natural teeth. 2. The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Carious Tooth, Dental Wear
- What is being tested?
- Vita Ambria and IPs emax onaly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to Aug 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patient is healthy.
- 18-50 years old.
- Normal occlusion.
- Good oral hygiene.
- Tooth with complete root apex.
- Tooth with moderate coronal decay.
Who cannot join
- Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine , Al Azhar University
Cairo
Abdelaziz H Abdelaziz, M.D.Sc, 002(01005494627)
About this study
Official title: Evaluation of Wear Behavior of Onlay Restorations Constructed From Two Types of Glass Ceramics
The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA \& IPS e.max Press and their opposing natural teeth.
- The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.
Read the detailed description
A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated by a blind and calibrated two examiner using the FDI World Dental Federation criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.
Both groups will receive Onlay preparation . Digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using CAD/CAM software. After that, the wax pattern will be invested and final onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: The amount of wear will be evaluated according to FDI standard.
- Conditions
- Carious Tooth, Dental Wear
- Being tested
- Vita Ambria, IPs emax onaly
- Medical subject headings
- Tooth Wear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vita AmbriaOther
onlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria)
IPs emax onalyOther
onlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax)
| Study group | Role | What they receive |
|---|---|---|
| Vita Ambria onlay | Experimental | The onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system. Receives: Other: Vita Ambria |
| IPS emax onlay | Active comparator | The onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system Receives: Other: IPs emax onaly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wear evaluation
The amount of wear will be defined as follows:
- Intra oral scanner will be used to scan the surface of the restorations and opposing natural enamel after achieving a complete dry surface by isolation.
- The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software.
- Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.
Measured: 1 year follow up
Secondary outcomes (2)
contact points and food impaction
contact points and food impaction of the onlay restoration will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows: Grade 1: Normal contact point (floss or 25 µm metal blade of can be inserted but not 50 µm blade).
Grade 2: Slightly too strong but no disadvantage:
Grade 3: Slightly too weak, no indication of damage to tooth, gingivae or periodontal structures (50 µm metal blade can pass easily but not 100 µm).
Grade 4:Too weak (100 µm metal blade can pass) and possible damage (food impaction). Repair possible.
Grade 5:Too weak and/or clear damage (food impaction) and/or pain/gingivitis. Requires replacement.
Measured: 1 year follow up
Radiographic examination
Radiographic examination will be evaluated according to FDI standard (Grade 1-5), which has been defined as follows:
Grade 1: No pathology, harmonious transition between restoration and tooth. Grade 2: (2.1) acceptable cement excess present ,(2.2) Positive/negative step present at margin<150 µm.
Grade 3: (3.1) Marginal gap < 200 µm, (3.2)Negative steps visible < 250 µm and no adverse effects noticed,(3.3) Poor radiopacity of restorative material.
Grade 4: (4.1) Marginal gap >250 µm, (4.2) Cement excess accessible but not removable,(4.3) Negative steps >250µm and repairable.
Grade 5:(5.1) Secondary caries, large gaps ,(5.2) Apical pathology ,(5.3) Fracture/loss of restoration or tooth
Measured: 1 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 posted24 Jun 2022
- Study start1 Aug 2022
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carious ToothStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abd Elaziz Helmy Abd Elaziz Mahmoud Elhamrawy, Al-Azhar University
- Investigators
- Hussien RA Mohamed, Ph.D.Sc, Study director, Assistant Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar UniversityTamer AB Hamza, Professor, Study chair, Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431465
- Sponsor's protocol ID
- Wear of Vita Ambria
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffis E, Abd Alraheam I, Boushell L, Donovan T, Fasbinder D, Sulaiman TA. Tooth-cusp preservation with lithium disilicate onlay restorations: A fatigue resistance study. J Esthet Restor Dent. 2022 Apr;34(3):512-518. doi: 10.1111/jerd.12666. Epub 2020 Oct 3.
PubMed 33009726Lee JH, Myagmar G, Kwon HB, Han JS. A digital method for wear volume loss analysis using a single-scan three-dimensional dataset. J Dent Sci. 2022 Jan;17(1):638-641. doi: 10.1016/j.jds.2021.06.015. Epub 2021 Jul 4.
PubMed 35028110
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Behavior of Onlay Restorations Constructed From Two Types of Glass Ceramics
- ClinicalTrials.gov ID
- NCT05431465
- Acronym / sponsor ID
- Wear of Vita Ambria
- Conditions
- Carious Tooth, Dental Wear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 24 Jun 2022 (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 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA \& IPS e.max Press and their opposing natural teeth.
- The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.
Detailed description
A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated by a blind and calibrated two examiner using the FDI World Dental Federation criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.
Both groups will receive Onlay preparation . Digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using CAD/CAM software. After that, the wax pattern will be invested and final onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: The amount of wear will be evaluated according to FDI standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vita Ambria onlay | Experimental | Other: Vita AmbriaThe onlays will be constructed from Zirconia reinforced Lithium disilicate (Vita Ambria) glass ceramic system. |
| IPS emax onlay | Active comparator | Other: IPs emax onalyThe onlays will be constructed from Lithium disilicate (IPS e-max press) glass ceramic system |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- The patient is healthy.
- 18-50 years old.
- Normal occlusion.
- Good oral hygiene.
- Tooth with complete root apex.
Key exclusion criteria (1 listed)
- Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.
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 |
|---|---|---|
| Vita Ambriaonlay restoration will be fabricated from Zirconia reinforced lithium disilicate glass ceramic(vita ambria) | Other | Vita Ambria onlay |
| IPs emax onalyonlay restoration will be fabricated from lithium disilicate glass ceramic(IPS emax) | Other | IPS emax onlay |
Primary outcome
Wear evaluation
Time frame: 1 year follow up
The amount of wear will be defined as follows: 1. Intra oral scanner will be used to scan the surface of the restorations and opposing natural enamel after achieving a complete dry surface by isolation. 2. The recordings that measured at base line and 12 month periods will be superimposed on each other by specific software. 3. Mean values and standard deviations of the amount of wear for all restorations' and opposing enamel's will be statistically analyzed.
2 secondary outcomes
contact points and food impaction
Time frame: 1 year follow up
Radiographic examination
Time frame: 1 year follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
- Background: PubMed 33009726Griffis E, Abd Alraheam I, Boushell L, Donovan T, Fasbinder D, Sulaiman TA. Tooth-cusp preservation with lithium disilicate onlay restorations: A fatigue resistance study. J Esthet Restor Dent. 2022 Apr;34(3):512-518. doi: 10.1111/jerd.12666. Epub 2020 Oct 3.
- Background: PubMed 35028110Lee JH, Myagmar G, Kwon HB, Han JS. A digital method for wear volume loss analysis using a single-scan three-dimensional dataset. J Dent Sci. 2022 Jan;17(1):638-641. doi: 10.1016/j.jds.2021.06.015. Epub 2021 Jul 4.
Related trials for Carious Tooth
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Clinical Performance of Two HEMA-Free Universal Adhesive Systems
Cervical Caries
Active, not recruiting
Total Pulpotomy With Two Repair Cements in Hypomineralized Teeth
Molar-Incisor Hypomineralization (MIH)
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Active, not recruiting
Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis
Irreversible Pulpitis (Toothache)
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.
Hussien RA Mohamed, Ph.D.Sc study director
Assistant Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
Tamer AB Hamza, Professor study chair
Professor of Crown and Bridge, Faculty of Dental Medicine, Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vita Ambria and IPs emax onaly in people with Carious Tooth and Dental Wear, run by Al-Azhar 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 1 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 9 Mar 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?
Contact Abdelaziz HE Abdelaziz, M.D.Sc. (002 (01005494627), abdelazizelhamarawy.209@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear evaluation (time frame: 1 year follow up). 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 NCT05431465, which also lists 2 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 9 Mar 2023.