Caries,DentalNCT06114030
Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation
A study testing Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns in people with Caries,Dental and Crown of Tooth With Poor Contour, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
Deep margin elevation (DME) is a non-invasive restorative technique to relocate the deep cervical margin to a supragingival position using resin composite. This retrospective multicenter practice-based study will assess the long-term clinical performance and periodontal health of teeth restored with CAD-CAM crowns… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Caries,Dental, Crown of Tooth With Poor Contour, Broken Teeth
- What is being tested?
- Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Mar 2023to 30 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patient and indication for crown with or without DME.
Who cannot join
- poor oral hygiene and active periodontal disease.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University of Sharjah
Sharjah city, 7724
Sharjah registerar, registerar, registerar@sharjah.ac.ae
About this study
Official title: Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation: Up to 10-year Results
Deep margin elevation (DME) is a non-invasive restorative technique to relocate the deep cervical margin to a supragingival position using resin composite. This retrospective multicenter practice-based study will assess the long-term clinical performance and periodontal health of teeth restored with CAD-CAM crowns with or without DME. Patients who will receive CAD-CAM lithium disilicate (LD) crowns with or without DME between 2013 and 2023 at multiple private practices will be included. When indicated, DME will be performed using resin-based restoration. Clinical assessment of the crowns and supporting periodontal structures will be performed following the modified United States Public Health Service (USPHS) criteria. Intra-oral photographs, periapical and bitewing radiographs will be taken for further assessment by three evaluators. Kaplan Meier survival analyses will be performed.
Read the detailed description
The ethical approval to conduct this retrospective multicenter practice-based study was obtained from the Research Ethics Committee at the University of Sharjah (REC-23-09-11-01-F). The present report will complie with the STROBE guidelines for cohort studies.
Participants selection Patient records at 7 private practices in the UAE will be searched for the presence of posterior LD CAD-CAM crowns during 2013 to 2016. Inclusion criteria: adult patient and indication for crown with or without DME. Exclusion criteria: poor oral hygiene and active periodontal disease. A total of 560 eligible patients will be invited to a clinical examination.
Clinical Examination The clinical evaluation will be conducted by three calibrated independent prosthodontists. Patients will be requested to read and sign an informed consent form to participate in the study. Intraoral photographs, Periapical and bitewing radiographs will be obtained to assess the emergence profile of the DEM which should ideally reproduce the normal morphology. Both the crowned tooth and the contralateral tooth were assessed clinically for the following parameters: pocket depth (PD), BoP, and presence of plaque using a plaque indicator liquid (Mira-2 Ton Liquid, Hager \& Werken; Duisburg, Germany). Bone level will be assessed by comparing a measurement from the margin of the tooth to the crest of the bone on bitewing radiographs to corresponding preoperative radiographs.
A comprehensive assessment of the restored teeth will be carried out following the modified United States Public Health Service (USPHS) criteria. The location of crown margin will be recorded clinically and radiographically to assess the association between periodontal health and margin location. The primary outcomes will be the survival rate and time to event. The secondary outcome will be the success rate. The success is defined as a crown that had remained unchanged over the observation period, while survival is defined as a crown that was in situ at the examination visit but might exhibits chipping or have been repaired. Failure will be scored for the followings: recurrent caries, loss of vitality, tooth fracture, and crown fracture.
Statistical analysis Descriptive statistics were computed with a statistical software program (IBM SPSS Statistics, v29; IBM Corp., Armonk, NY, USA). Each complication will be considered as a statistical event. The statistical testing will be 2-tailed (a=.05). The McNemar chi-squared and Fisher exact tests will be used to assess the severity of PD, BoP and plaque deposition. Odds ratios and their 95% confidence intervals will be reported. The Pearson chi-squared test for differences in proportions will be used to assess the relationship between the location of margins and the associated condition of the periodontal tissues. Kaplan-Meier survival analysis will be performed to calculate the overall crown survival and success probabilities. Cox regression models will be used to evaluate the effect of various confounding factors on the survival and success rates.
- Conditions
- Caries,Dental, Crown of Tooth With Poor Contour, Broken Teeth, Survival, Prosthesis, Failure, Prosthesis
- Being tested
- Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns
- Medical subject headings
- Dental Caries, Tooth Fractures, Prosthesis Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crownsProcedure or surgery
Also called Filtek Supreme XTE (3M ESPE, Seefeld, Germany), Tetric EvoCeram (Ivoclar Vivadent AG, Schaan, Lichtenstein), Estelite Sigma Qquick (Tokuyama, Tokyo, Japan), IPS e.max CAD (Ivoclar Vivadent AG, Schaan, Lichtenstein)
Restoration of the deep margin by composite restorations such as: Filtek Supreme XTE, Tetric EvoCeram, Estelite Sigma Qquick followed by Lithium disilicate glass-ceramic CAD/CAM crowns (IPS e.max CAD).
| Study group | Role | What they receive |
|---|---|---|
| Deep margin elevation followed by crowns | Other | Teeth restored with DME and crowns Receives: Procedure: Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survival rate of teeth restored with or without DME and crowns.
Number of survived crowns in the presence or absence of DME
Measured: 10 years
Number of failed crowns in the presence or absence of DME
Measured: 10 years
Secondary outcomes (3)
Change from baseline in pocket depth
Measured: 10 years
Change from baseline in bleeding of probing
Measured: 10 years
Periodontal responses in response to deep (subgingival) margins
Change from baseline in bone level cervically
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Aziz, University of Sharjah
- Investigators
- Ahmed M Aziz, PhD, Principal investigator, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114030
- Sponsor's protocol ID
- 50571100
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographical Evaluation of CAD-CAM Crowns With and Without Deep Margin Elevation: Up to 10-year Results
- ClinicalTrials.gov ID
- NCT06114030
- Acronym / sponsor ID
- 50571100
- Conditions
- Caries,Dental, Crown of Tooth With Poor Contour, Broken Teeth, Survival, Prosthesis, Failure, Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 2 Nov 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.
Deep margin elevation (DME) is a non-invasive restorative technique to relocate the deep cervical margin to a supragingival position using resin composite. This retrospective multicenter practice-based study will assess the long-term clinical performance and periodontal health of teeth restored with CAD-CAM crowns with or without DME. Patients who will receive CAD-CAM lithium disilicate (LD) crowns with or without DME between 2013 and 2023 at multiple private practices will be included. When indicated, DME will be performed using resin-based restoration. Clinical assessment of the crowns and supporting periodontal structures will be performed following the modified United States Public Health Service (USPHS) criteria. Intra-oral photographs, periapical and bitewing radiographs will be taken for further assessment by three evaluators. Kaplan Meier survival analyses will be performed.
Detailed description
The ethical approval to conduct this retrospective multicenter practice-based study was obtained from the Research Ethics Committee at the University of Sharjah (REC-23-09-11-01-F). The present report will complie with the STROBE guidelines for cohort studies.
Participants selection Patient records at 7 private practices in the UAE will be searched for the presence of posterior LD CAD-CAM crowns during 2013 to 2016. Inclusion criteria: adult patient and indication for crown with or without DME. Exclusion criteria: poor oral hygiene and active periodontal disease. A total of 560 eligible patients will be invited to a clinical examination.
Clinical Examination The clinical evaluation will be conducted by three calibrated independent prosthodontists. Patients will be requested to read and sign an informed consent form to participate in the study. Intraoral photographs, Periapical and bitewing radiographs will be obtained to assess the emergence profile of the DEM which should ideally reproduce the normal morphology. Both the crowned tooth and the contralateral tooth were assessed clinically for the following parameters: pocket depth (PD), BoP, and presence of plaque using a plaque indicator liquid (Mira-2 Ton Liquid, Hager \& Werken; Duisburg, Germany). Bone level will be assessed by comparing a measurement from the margin of the tooth to the crest of the bone on bitewing radiographs to corresponding preoperative radiographs.
A comprehensive assessment of the restored teeth will be carried out following the modified United States Public Health Service (USPHS) criteria. The location of crown margin will be recorded clinically and radiographically to assess the association between periodontal health and margin location. The primary outcomes will be the survival rate and time to event. The secondary outcome will be the success rate. The success is defined as a crown that had remained unchanged over the observation period, while survival is defined as a crown that was in situ at the examination visit but might exhibits chipping or have been repaired. Failure will be scored for the followings: recurrent caries, loss of vitality, tooth fracture, and crown fracture.
Statistical analysis Descriptive statistics were computed with a statistical software program (IBM SPSS Statistics, v29; IBM Corp., Armonk, NY, USA). Each complication will be considered as a statistical event. The statistical testing will be 2-tailed (a=.05). The McNemar chi-squared and Fisher exact tests will be used to assess the severity of PD, BoP and plaque deposition. Odds ratios and their 95% confidence intervals will be reported. The Pearson chi-squared test for differences in proportions will be used to assess the relationship between the location of margins and the associated condition of the periodontal tissues. Kaplan-Meier survival analysis will be performed to calculate the overall crown survival and success probabilities. Cox regression models will be used to evaluate the effect of various confounding factors on the survival and success rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep margin elevation followed by crowns | Other | Procedure: Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crownsTeeth restored with DME and crowns |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient and indication for crown with or without DME.
Key exclusion criteria (1 listed)
- poor oral hygiene and active periodontal disease.
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 |
|---|---|---|
| Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crownsAlso: Filtek Supreme XTE (3M ESPE, Seefeld, Germany), Tetric EvoCeram (Ivoclar Vivadent AG, Schaan, Lichtenstein), Estelite Sigma Qquick (Tokuyama, Tokyo, Japan), IPS e.max CAD (Ivoclar Vivadent AG, Schaan, Lichtenstein)Restoration of the deep margin by composite restorations such as: Filtek Supreme XTE, Tetric EvoCeram, Estelite Sigma Qquick followed by Lithium disilicate glass-ceramic CAD/CAM crowns (IPS e.max CAD). | Procedure or surgery | Deep margin elevation followed by crowns |
Primary outcome
The survival rate of teeth restored with or without DME and crowns.
Time frame: 10 years
Number of survived crowns in the presence or absence of DME
Number of failed crowns in the presence or absence of DME
Time frame: 10 years
3 secondary outcomes
Change from baseline in pocket depth
Time frame: 10 years
Change from baseline in bleeding of probing
Time frame: 10 years
Periodontal responses in response to deep (subgingival) margins
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Ahmed M Aziz, PhD principal investigator
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep margin elevation with composite resin and Lithium disilicate glass-ceramic crowns in people with Caries,Dental and Crown of Tooth With Poor Contour, run by University of Sharjah at 1 site in United Arab Emirates.
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 1 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 2 Nov 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 United Arab Emirates. 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 Ahmed M Aziz, PhD (+97165057312, a.aziz@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survival rate of teeth restored with or without DME and crowns. (time frame: 10 years). 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 2 Nov 2023.