Dental LeakageNCT06377423
Comparison Between Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases
A study testing Direct technique and Indirect technique in people with Dental Leakage, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Leakage
- What is being tested?
- Direct technique and Indirect technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Aug 2021to 10 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients needed diastema closure.
- Patients with normal and full occlusion.
- Patients must have a good oral hygiene.
- Patients with a tooth respond positively to an electric pulp tester.
Who cannot join
- High caries risk patients with extremely poor oral hygiene.
- Patients with periodontally-involved teeth.
- Patients with heavy bruxism habits and clenching.
- Patients involved in orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: 2-years Follow-up
Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years.
Read the detailed description
Restorative materials and curing device In the current study, the manufacturer's instructions were followed for the use of the nanofilled composite resin (Estelite Asteria, Tokuyama Dental, Japan) for direct laminate veneers and IPS e.max Press (Ivoclar Vivadent, Amherst, NY, USA) for indirect laminate ceramic veneers. A light curing device with an output density of 655 mW/cm2 (LED Bluephase C5, Ivoclar, Vivadent, Amherst, NY, USA) was used. Demetron LED light meters were used to measure the light curing unit's intensity regularly (Demetron Research Corp., Danbury, CT, USA). Brand name, description, chemical composition, and manufacturers of the materials are presented in Table 1.
Study design, blinding \& randomization The Consolidated Standards of Reporting Trials statement was adhered to in the description of the experimental design. This study was a randomized controlled clinical trial that was double-blinded for both trial participants and outcome assessors. Randomization was performed using the flip of a coin for the choice of material. Using computerized sequence generating (www. randomizer.org), participants were divided into two groups with a 1:1 allocation ratio.
- Conditions
- Dental Leakage
- Being tested
- Direct technique, Indirect technique
- Keywords
- Ceramics, Composite, Randomized clinical trial, diastema closure
- Medical subject headings
- Dental Leakage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct techniqueProcedure or surgery
The composite was placed directly using free-hand technique
Indirect techniqueProcedure or surgery
The ceramic was placed using indirect method via laboratory casts
| Study group | Role | What they receive |
|---|---|---|
| Estelite esteria composite | Experimental | Half of the patients received composite veneers using direct method Receives: Procedure: Direct technique |
| IPS Emax press ceramic | Experimental | Half of the patients received ceramic veneers using indirect technique Receives: Procedure: Indirect technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage % of patients with marginal staining
The percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given scores from 0 to 5
Measured: 2 years after restoration procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 Aug 2021
- Primary completion1 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental LeakageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdallah Elshehri, Phd, Study director, Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377423
- Sponsor's protocol ID
- A54678775
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan can be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Direct Composite and Indirect Ceramic Laminate Veneers in Multiple Diastema Closure Cases: 2-years Follow-up
- ClinicalTrials.gov ID
- NCT06377423
- Acronym / sponsor ID
- A54678775
- Conditions
- Dental Leakage
- Keywords
- Ceramics, Composite, Randomized clinical trial, diastema closure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 22 Apr 2024 (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.
Thus, the present study aimed to evaluate the longevity of direct composite compared to indirect ceramic laminate veneers in multiple diastema closure cases using USPHS criteria. The formulated null hypothesis was that there is no significant difference in the clinical performance of direct composite and indirect ceramic laminate veneers in multiple diastema closure cases over two years.
Detailed description
Restorative materials and curing device In the current study, the manufacturer's instructions were followed for the use of the nanofilled composite resin (Estelite Asteria, Tokuyama Dental, Japan) for direct laminate veneers and IPS e.max Press (Ivoclar Vivadent, Amherst, NY, USA) for indirect laminate ceramic veneers. A light curing device with an output density of 655 mW/cm2 (LED Bluephase C5, Ivoclar, Vivadent, Amherst, NY, USA) was used. Demetron LED light meters were used to measure the light curing unit's intensity regularly (Demetron Research Corp., Danbury, CT, USA). Brand name, description, chemical composition, and manufacturers of the materials are presented in Table 1.
Study design, blinding \& randomization The Consolidated Standards of Reporting Trials statement was adhered to in the description of the experimental design. This study was a randomized controlled clinical trial that was double-blinded for both trial participants and outcome assessors. Randomization was performed using the flip of a coin for the choice of material. Using computerized sequence generating (www. randomizer.org), participants were divided into two groups with a 1:1 allocation ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Estelite esteria composite | Experimental | Procedure: Direct techniqueHalf of the patients received composite veneers using direct method |
| IPS Emax press ceramic | Experimental | Procedure: Indirect techniqueHalf of the patients received ceramic veneers using indirect technique |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients needed diastema closure.
- Patients with normal and full occlusion.
- Patients must have a good oral hygiene.
- Patients with a tooth respond positively to an electric pulp tester.
Key exclusion criteria (4 listed)
- High caries risk patients with extremely poor oral hygiene.
- Patients with periodontally-involved teeth.
- Patients with heavy bruxism habits and clenching.
- Patients involved in orthodontic treatment.
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 |
|---|---|---|
| Direct techniqueThe composite was placed directly using free-hand technique | Procedure or surgery | Estelite esteria composite |
| Indirect techniqueThe ceramic was placed using indirect method via laboratory casts | Procedure or surgery | IPS Emax press ceramic |
Primary outcome
Percentage % of patients with marginal staining
Time frame: 2 years after restoration procedure
The percentage of marginal staining in patients was clinically assessed using USPHS criteria. Restorations were given scores from 0 to 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: Yes. Plan can be shared with other researchers
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.
Abdallah Elshehri, Phd study director
Dept. of Conservative Dental Sciences, College of Dentistry, Prince Sattam Bin Abdulaziz 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 Direct technique and Indirect technique in people with Dental Leakage, run by Prince Sattam Bin Abdulaziz University at 1 site in Saudi Arabia.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Apr 2024. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage % of patients with marginal staining (time frame: 2 years after restoration procedure). 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 22 Apr 2024.