CrownsNCT05735509
Comparison of Scanning With and Without Rubber Dam for Overlay Restorations
A study testing Rubber dam in people with Crowns, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
The use of rubber dam when performing adhesive restorations improves the quality of the treatment. The widespread use of this type of restorations makes it increasingly necessary to use this type of isolation of the operative field. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crowns
- What is being tested?
- Rubber dam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2023to 5 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Need of an overlay restoration
Who cannot join
- No need of overlay restoration
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clinica Universitaria d'Odontologia
Sant Cugat Del Vallés, Barcelona, 08195
About this study
The use of rubber dam when performing adhesive restorations improves the quality of the treatment. The widespread use of this type of restorations makes it increasingly necessary to use this type of isolation of the operative field. At the same time, the use of CAD/CAM systems in dentistry has recently become more widespread, which means that chairside systems are being used more and more frequently. Given that in indirect restorations it is necessary to place the rubber dam at the time of cementation, it has been proposed to take optical impressions of the preparation with the rubber dam already in place. For this it is necessary to have previous records that are cut out and rescanned. Since there are authors who have described that rescanning can cause defects in the meshes, in this work we try to compare both types of scanning in a specific type of restorations, the overlays. For this purpose, scans of the tooth preparation with and without rubber dam are taken, and a random decision is made on the basis of which scan the restoration is made. Then it is taken to the mouth and the marginal fit, contact points and occlusion of the restoration are evaluated. The results of the group made from the scan without dam are compared with those of the group made from the scan with dam. The two scans of each case are also compared to evaluate the differences.
Read the detailed description
- Introduction: The use of rubber dam in restorative dentistry is important in order to improve the quality of restorations. The incorporation of CAD/CAD systems has led to an increase in the use of chairside techniques. In this work we intend to study in vivo to what extent the optical impressions obtained with rubber dam are equivalent to those taken without rubber dam. For better standardization, overlay restorations are studied.
- Aims: To compare overlay restorations obtained from a scan with rubber dam placed versus restorations of the same type obtained with a scan without rubber dam.
- Material and methods: (a) Number of patients to be treated: 30. b) Number of visits per patient: 1 c) Brief description of the different techniques used in the study, authorized and validated in the literature (3-5 lines). The use of overlay restorations is widely validated in the literature. In the digital era, rubber dam and non-rubber dam impressions are described in the literature and are used interchangeably. As there is no clinical evidence that both techniques have the same clinical efficacy, we decided to perform this in vivo comparison study.
- Benefits and harms for the patient of participating in the study (3-5 lines). Participation in the study does not involve any harm to the patient. It is all performed in the same working time, with identical materials and identical clinical technique. It does not bring any particular benefit to the patient. It is explained to the patient that his/her participation contributes to the improvement of scientific knowledge without physical, economic or material cost.
- Alternative treatment in case the patient does not wish to participate in the clinical study (3-5 lines). The same treatment is given whether the patient participates or not. The patient is informed that an overlay is required, the possible complications of this treatment are explained to him/her, and if he/she accepts, he/she is asked if he/she would object to participate in the study. Participation involves consenting to the analysis of the scans and the final evaluation of the restoration.
- Treatment to be carried out in the event of complications arising in the patient, once the clinical study has begun (3-5 lines). The clinical study is performed in a single visit and is independent of possible complications of the restoration or the tooth.
- Material necessary to carry out the study (3-5 lines). Intraoral anesthesia, milling burs, a Primescan intraoral scanner, rubber dam, W8A clamp, two-step adhesive, 5% hydrofluoric acid, silane, clamp holder, dam drill, glycerin are required. No specific material is required for the study with respect to that required for a patient who does not wish to participate in the study.
- Evaluation of experimental and statistical results (3 lines). The sample was calculated by means of G power 3 version 3.1.9 software, 80% power and alpha=0.05. A sample of 30 was determined. The Kappa index will be used to evaluate the concordance between the two evaluators, interpreting the results with the Landis and Koch concordance table. Pearson's test will be used to evaluate the fit, occlusal contacts, interproximal contact points and choice of the best impression.
- Conditions
- Crowns
- Being tested
- Rubber dam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubber damDevice
Intraoral impressions can be taken with rubber dam in place. The care provider will take two impressions, one with the rubber dam in place and one without. The investigator will randomly chose one of the two impressions for crown manufacturing, and the crown will be delivered by the care provider blindly
| Study group | Role | What they receive |
|---|---|---|
| Before rubber dam | Active comparator | Impression taken before rubber dam placement is used for crown manufacturing Receives: Device: Rubber dam |
| After rubber dam | Experimental | Impression taken after rubber dam placement is used for crown manufacturing Receives: Device: Rubber dam |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall result of final crown
The final crown is judged by the care provider. A 10 cm Visual analogue scale (VAS) is used. 0 (unacceptable) is placed in left end, and 10 (perfect) is placed in the right end.
Measured: One day
Marginal fit of final crown
Marginal fit will be assessed with an exploratory probe under x3.50 magnification, observing the existence of marginal fit in mesial, distal, buccal, and lingual surfaces. The probe used will be a #23/6 explorer which measures 0.22 mm at 1 mm from the tip. A score of 0 (no perception of the gap when probing), 1 (tip of the probe slightly entered the gap), and 2 (the tip clearly entered the gap) will be used
Measured: One day
Contact points fit
Interproximal contact points will be assessed with waxed dental floss. A score of 0 (incorrect contact point), 1 (correct contact point) will be used
Measured: One day
Occlusal adjustment
Occlusal contacts will be verified with Bausch Arti-Check Micro-Thin 40μ articulating paper and Arti-Fol Metallic Shimstock-Film 12 μ. A score of 0 (no occlusal contacts), 1 (correct occlusal contacts) and 2 (too high occlusal contacts) will be used.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start30 Jan 2023
- Primary completion5 Mar 2023
- Study completion5 Mar 2023
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 CrownsStudies 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
- Model description
- Tooth to be restored are randomly assigned to on of two groups. In one impressions are taken before placing the rubber dam and in the second impressions are taken after placing the rubber dam.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Roig Cayón, Universitat Internacional de Catalunya
- Investigators
- José Espona, DDS, Principal investigator, Universidad Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735509
- Sponsor's protocol ID
- REST-ECL-2023-01
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be published
Publications
Henarejos-Domingo V, Clavijo V, Blasi A, Madeira S, Roig M. Digital scanning under rubber dam: An innovative method for making definitive impressions in fixed prosthodontics. J Esthet Restor Dent. 2021 Oct;33(7):976-981. doi: 10.1111/jerd.12787. Epub 2021 May 18.
PubMed 34008328Espona J, Roig E, Ali A, Vidal C, Garcia-Font M, Roig M, Figueras O. Optical impressions assessment for overlay restorations with rubber dam: A clinical trial. J Dent. 2024 Apr;143:104825. doi: 10.1016/j.jdent.2023.104825. Epub 2023 Dec 28.
PubMed 38157974
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Scanning With and Without Rubber Dam for Overlay Restorations
- ClinicalTrials.gov ID
- NCT05735509
- Acronym / sponsor ID
- REST-ECL-2023-01
- Conditions
- Crowns
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 5 Mar 2023 (actual)
- Study completion
- 5 Mar 2023 (actual)
- First posted
- 21 Feb 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 use of rubber dam when performing adhesive restorations improves the quality of the treatment. The widespread use of this type of restorations makes it increasingly necessary to use this type of isolation of the operative field. At the same time, the use of CAD/CAM systems in dentistry has recently become more widespread, which means that chairside systems are being used more and more frequently. Given that in indirect restorations it is necessary to place the rubber dam at the time of cementation, it has been proposed to take optical impressions of the preparation with the rubber dam already in place. For this it is necessary to have previous records that are cut out and rescanned. Since there are authors who have described that rescanning can cause defects in the meshes, in this work we try to compare both types of scanning in a specific type of restorations, the overlays. For this purpose, scans of the tooth preparation with and without rubber dam are taken, and a random decision is made on the basis of which scan the restoration is made. Then it is taken to the mouth and the marginal fit, contact points and occlusion of the restoration are evaluated. The results of the group made from the scan without dam are compared with those of the group made from the scan with dam. The two scans of each case are also compared to evaluate the differences.
Detailed description
- Introduction: The use of rubber dam in restorative dentistry is important in order to improve the quality of restorations. The incorporation of CAD/CAD systems has led to an increase in the use of chairside techniques. In this work we intend to study in vivo to what extent the optical impressions obtained with rubber dam are equivalent to those taken without rubber dam. For better standardization, overlay restorations are studied.
- Aims: To compare overlay restorations obtained from a scan with rubber dam placed versus restorations of the same type obtained with a scan without rubber dam.
- Material and methods: (a) Number of patients to be treated: 30. b) Number of visits per patient: 1 c) Brief description of the different techniques used in the study, authorized and validated in the literature (3-5 lines). The use of overlay restorations is widely validated in the literature. In the digital era, rubber dam and non-rubber dam impressions are described in the literature and are used interchangeably. As there is no clinical evidence that both techniques have the same clinical efficacy, we decided to perform this in vivo comparison study.
- Benefits and harms for the patient of participating in the study (3-5 lines). Participation in the study does not involve any harm to the patient. It is all performed in the same working time, with identical materials and identical clinical technique. It does not bring any particular benefit to the patient. It is explained to the patient that his/her participation contributes to the improvement of scientific knowledge without physical, economic or material cost.
- Alternative treatment in case the patient does not wish to participate in the clinical study (3-5 lines). The same treatment is given whether the patient participates or not. The patient is informed that an overlay is required, the possible complications of this treatment are explained to him/her, and if he/she accepts, he/she is asked if he/she would object to participate in the study. Participation involves consenting to the analysis of the scans and the final evaluation of the restoration.
- Treatment to be carried out in the event of complications arising in the patient, once the clinical study has begun (3-5 lines). The clinical study is performed in a single visit and is independent of possible complications of the restoration or the tooth.
- Material necessary to carry out the study (3-5 lines). Intraoral anesthesia, milling burs, a Primescan intraoral scanner, rubber dam, W8A clamp, two-step adhesive, 5% hydrofluoric acid, silane, clamp holder, dam drill, glycerin are required. No specific material is required for the study with respect to that required for a patient who does not wish to participate in the study.
- Evaluation of experimental and statistical results (3 lines). The sample was calculated by means of G power 3 version 3.1.9 software, 80% power and alpha=0.05. A sample of 30 was determined. The Kappa index will be used to evaluate the concordance between the two evaluators, interpreting the results with the Landis and Koch concordance table. Pearson's test will be used to evaluate the fit, occlusal contacts, interproximal contact points and choice of the best impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Tooth to be restored are randomly assigned to on of two groups. In one impressions are taken before placing the rubber dam and in the second impressions are taken after placing the rubber dam.
| Arm | Type | Receives |
|---|---|---|
| Before rubber dam | Active comparator | Device: Rubber damImpression taken before rubber dam placement is used for crown manufacturing |
| After rubber dam | Experimental | Device: Rubber damImpression taken after rubber dam placement is used for crown manufacturing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Need of an overlay restoration
Key exclusion criteria (1 listed)
- No need of overlay restoration
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 |
|---|---|---|
| Rubber damIntraoral impressions can be taken with rubber dam in place. The care provider will take two impressions, one with the rubber dam in place and one without. The investigator will randomly chose one of the two impressions for crown manufacturing, and the crown will be delivered by the care provider blindly | Device | After rubber dam, Before rubber dam |
Primary outcome
overall result of final crown
Time frame: One day
The final crown is judged by the care provider. A 10 cm Visual analogue scale (VAS) is used. 0 (unacceptable) is placed in left end, and 10 (perfect) is placed in the right end.
Marginal fit of final crown
Time frame: One day
Marginal fit will be assessed with an exploratory probe under x3.50 magnification, observing the existence of marginal fit in mesial, distal, buccal, and lingual surfaces. The probe used will be a #23/6 explorer which measures 0.22 mm at 1 mm from the tip. A score of 0 (no perception of the gap when probing), 1 (tip of the probe slightly entered the gap), and 2 (the tip clearly entered the gap) will be used
Contact points fit
Time frame: One day
Interproximal contact points will be assessed with waxed dental floss. A score of 0 (incorrect contact point), 1 (correct contact point) will be used
Occlusal adjustment
Time frame: One day
Occlusal contacts will be verified with Bausch Arti-Check Micro-Thin 40μ articulating paper and Arti-Fol Metallic Shimstock-Film 12 μ. A score of 0 (no occlusal contacts), 1 (correct occlusal contacts) and 2 (too high occlusal contacts) will be used.
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 7 Mar 2023.
- Background: PubMed 34008328Henarejos-Domingo V, Clavijo V, Blasi A, Madeira S, Roig M. Digital scanning under rubber dam: An innovative method for making definitive impressions in fixed prosthodontics. J Esthet Restor Dent. 2021 Oct;33(7):976-981. doi: 10.1111/jerd.12787. Epub 2021 May 18.
- Derived from this study: PubMed 38157974Espona J, Roig E, Ali A, Vidal C, Garcia-Font M, Roig M, Figueras O. Optical impressions assessment for overlay restorations with rubber dam: A clinical trial. J Dent. 2024 Apr;143:104825. doi: 10.1016/j.jdent.2023.104825. Epub 2023 Dec 28.
- Individual participant dataSharing planned: No. All data will be published
Related trials for Crowns
Active, not recruitingObservational study
Influence of Prosthetic Characteristics of Implant-Supported Crowns on Peri-implant Health and Osseointegration: A Comparison Between Digital and Conventional Workflows
Implant-supported Single Crowns, Osseointegration
Recruiting
Clinical Evaluation of Bioflx Crowns in Restoring Primary Anterior Teeth
Clinical, Primary Teeth
Active, not recruiting
Clinical Evaluation of Three-Dimensional (3D) Printing Resin Nanoceramic Crown Restoration.
3d Printing Ceramic Restoration, Nanoceramic Crown Restoration for Posterior Teeth
Active, not recruiting
Sleeved vs. Sleeveless Guides for Immediate Implant Placement
Tooth Loss, Maxillary Premolar Area
Not yet recruiting
Postoperative Bite Force After Bioflx and Zirconia Crowns in Children
Bite Force, Masseter Muscle
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.
José Espona, DDS principal investigator
Universidad Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rubber dam in people with Crowns, run by Universitat Internacional de Catalunya at 1 site in Spain.
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: finished, as of the sponsor's last update on 7 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 Spain. 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?
overall result of final crown (time frame: One day). The study lists 4 primary outcomes in all. 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 NCT05735509, 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 7 Mar 2023; AzTrials last refreshed its copy on 6 Nov 2026.