CavityNCT05145322
In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography
A study testing Composite with 90 degree cavosurface angle and Composite with wide bevel in people with Cavity and Cavities of Teeth, run by University of Minnesota at 1 site in United States.
Trial summary
The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cavity, Cavities of Teeth
- What is being tested?
- Composite with 90 degree cavosurface angle and Composite with wide bevel
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2021to 16 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Good general health
- Fair oral hygiene
- At least 20 teeth in occlusion
- Available for the duration of the study
- Tooth-level inclusion Criteria:
- Participants with occlusal caries lesion/s in permanent posterior dentition except wisdom teeth
Show all 12Show fewer
- Caries lesion can be primary or secondary caries.
- Caries lesion is in the International Caries Detection and Assessment System (ICDAS) 4 or 5 category.
- The extent of the caries lesion bucco-lingually is likely not to exceed two-thirds of the occlusal table.
- The selected tooth must be able to be isolated with either rubber dam or other isolation technique during clinical procedure.
- The selected tooth must have an opposing antagonist.
- The selected tooth should be periodontally healthy.
Who cannot join
- Signs of bruxism
- Tooth-level exclusion criteria:
- Wisdom teeth
- Present with irreversible pulpitis.
- Periodontally compromised tooth that may require extraction.
- Caries lesions that would require cuspal coverage.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Read the detailed description
A recent review on clinical studies published on the performance of posterior composite restorations that were recalled at least up to 24-months reported that the overall failure rates for studies conducted between 2006-2016 was 13.13% and the two main reasons for failure in these two decades remained the same, i.e. secondary caries (25.68% - 29.47%) and composite fracture (28.84% - 39.07%). In in vitro studies, secondary caries has been attributed to interfacial gap or marginal defect both of which are consequences of polymerization contraction stresses. However, to date no clinical study has been able to directly establish a link between these stresses (and its consequences) to secondary caries. World Dental Federation (FDI) and United States Public Health Service (USPHS) clinical assessment criteria are the two main systems used to evaluate dental restorations in clinical trials. Both systems are designed to evaluate different properties of a restoration and properties pertaining to marginal integrity has been reported to be the most frequent properties investigated of a resin composite restoration. The grading descriptions for these properties are subjective and the discrimination between grading and between properties (especially between marginal stains and secondary caries) are problematic. Reasons to the lack of such a link is the discriminative deficiency of the clinical visual evaluation systems, the FDI and USPHS assessment criteria, and the ethical dilemma of restoration removal to assess for presence or absence of secondary caries. It has been long acknowledged that an objective clinical measuring tool and new clinical study designs for secondary caries is needed to further the understanding of secondary caries initiation and progression and how these relates to the marginal integrity of dental restorations. This brings forth the need of a sensitive yet clinically applicable assessment method for interfacial debonding and demineralization. Optical coherence tomography (OCT) is an optical, nondestructive and clinically- applicable technique that uses near infra red-light waves to provide cross-sectional images of structures. It is regarded as a standard-of-care equipment in ophthalmology and its clinical application has recently expanded to cardiology and dermatology. In dentistry, it has been used intra-orally in clinical trials to detect and quantify enamel demineralization and to detect mucosal and submucosal lesions. Optical coherence tomography and has been used to assess the performance of dental adhesives in a 12-month in vivo trial on non-carious cervical lesion. The authors reported that OCT outcome measures detected significant differences between groups while visual assessments did not. Hence supplementing the two visual assessment techniques with OCT outcome measures is expected to increase the sensitivity of short term interfacial debonding and demineralization changes. The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
- Conditions
- Cavity, Cavities of Teeth
- Being tested
- Composite with 90 degree cavosurface angle, Composite with wide bevel
- Keywords
- Dental Composite
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite with 90 degree cavosurface angleDevice
Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
Composite with wide bevelDevice
Lesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins Receives: Device: Composite with 90 degree cavosurface angle |
| Group 2 | Experimental | Lesion-specific cavity design with wide bevel throughout the cavity margins Receives: Device: Composite with wide bevel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
- No marginal staining
- Minor marginal staining, easily removable by polishing.
- Moderate marginal staining, not esthetically unacceptable.
- Pronounced marginal staining; major intervention necessary for improvement
- Deep marginal staining, not accessible for intervention.
Outcome will be reported as a single score at baseline.
Measured: Baseline
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
- No marginal staining
- Minor marginal staining, easily removable by polishing.
- Moderate marginal staining, not esthetically unacceptable.
- Pronounced marginal staining; major intervention necessary for improvement
- Deep marginal staining, not accessible for intervention.
Outcome will be reported as a single score at 6 months post-operative.
Measured: 6 months Follow-up
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining.
- No marginal staining
- Minor marginal staining, easily removable by polishing.
- Moderate marginal staining, not esthetically unacceptable.
- Pronounced marginal staining; major intervention necessary for improvement
- Deep marginal staining, not accessible for intervention.
Outcome will be reported as a single score at 18 months post-operative.
Measured: 18 months Follow-up
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining.
- None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized).
Outcome will be reported as a single score at baseline.
Measured: Baseline
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining.
- None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized).
Outcome will be reported as a single score at 6 months post-operative.
Measured: 6 months Follow-up
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining.
- None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized).
Outcome will be reported as a single score at 18 months post-operative.
Measured: 18 months Follow-up
Marginal Defect: World Dental Federation (FDI) Criteria - Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
- Harmonious outline, no gaps.
- Slight ditching, slight step/flashes, minor irregularities.
- Major irregularities, ditching or flash, steps
- Larger irregularities or steps (repair necessary)
- Generalized major gaps or irregularities.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Measured: Baseline
Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
- Harmonious outline, no gaps.
- Slight ditching, slight step/flashes, minor irregularities.
- Major irregularities, ditching or flash, steps
- Larger irregularities or steps (repair necessary)
- Generalized major gaps or irregularities.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Measured: 6 months Follow-up
Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect.
- Harmonious outline, no gaps.
- Slight ditching, slight step/flashes, minor irregularities.
- Major irregularities, ditching or flash, steps
- Larger irregularities or steps (repair necessary)
- Generalized major gaps or irregularities.
Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Measured: 18 months post-operative
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect.
- Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways.
- Detectable - V-shaped defect to the dentin-enamel junction
Outcome will be reported as a single score at baseline.
Measured: Baseline
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect.
- Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways.
- Detectable - V-shaped defect to the dentin-enamel junction
Outcome will be reported as a single score at 6 months post-operative.
Measured: 6 months Follow-up
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect.
- Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways.
- Detectable - V-shaped defect to the dentin-enamel junction
Outcome will be reported as a single score at 18 months post-operative.
Measured: 18 months post-operative
Secondary outcomes (3)
Backscattered Intensity at the Occlusal Cavosurface Angle.
Presence of elevated intensity at the cavosurface angle (margins) of the restoration, which indicates presence of minor marginal defect, is computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Measured: Baseline
Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.
Presence of tooth-resin interface gap of more than 0.1 mm at the cavosurface angle (margins) of the restoration, which indicates presence of moderate marginal defect, will be computed as percentage area of the outline of restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Measured: Baseline
Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls
Presence of elevated backscattered intensity along the superficial 2mm depth walls of the restoration, which indicates presence of debonding, will be computed as percentage volume of the restoration at every evaluation time point, i.e. baseline, 6 months and 18 months post-operative. Outcome is reported in units of percentage area.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start23 Sep 2021
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CavityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hooi Pin Chew, BDS, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145322
- Sponsor's protocol ID
- STUDY00011286
- Status last verified
- Oct 2024
- First submitted
- 12 Oct 2021
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PubMed 20628774Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am Dent Assoc. 1973 Aug;87(2):369-77. doi: 10.14219/jada.archive.1973.0421. No abstract available.
PubMed 4515696Nazari A, Sadr A, Shimada Y, Tagami J, Sumi Y. 3D assessment of void and gap formation in flowable resin composites using optical coherence tomography. J Adhes Dent. 2013 Jun;15(3):237-43. doi: 10.3290/j.jad.a28623.
PubMed 23534012
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Assessment of the Tooth-Resin Composite Interface Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT05145322
- Acronym / sponsor ID
- STUDY00011286
- Conditions
- Cavity, Cavities of Teeth
- Keywords
- Dental Composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Detailed description
A recent review on clinical studies published on the performance of posterior composite restorations that were recalled at least up to 24-months reported that the overall failure rates for studies conducted between 2006-2016 was 13.13% and the two main reasons for failure in these two decades remained the same, i.e. secondary caries (25.68% - 29.47%) and composite fracture (28.84% - 39.07%). In in vitro studies, secondary caries has been attributed to interfacial gap or marginal defect both of which are consequences of polymerization contraction stresses. However, to date no clinical study has been able to directly establish a link between these stresses (and its consequences) to secondary caries. World Dental Federation (FDI) and United States Public Health Service (USPHS) clinical assessment criteria are the two main systems used to evaluate dental restorations in clinical trials. Both systems are designed to evaluate different properties of a restoration and properties pertaining to marginal integrity has been reported to be the most frequent properties investigated of a resin composite restoration. The grading descriptions for these properties are subjective and the discrimination between grading and between properties (especially between marginal stains and secondary caries) are problematic. Reasons to the lack of such a link is the discriminative deficiency of the clinical visual evaluation systems, the FDI and USPHS assessment criteria, and the ethical dilemma of restoration removal to assess for presence or absence of secondary caries. It has been long acknowledged that an objective clinical measuring tool and new clinical study designs for secondary caries is needed to further the understanding of secondary caries initiation and progression and how these relates to the marginal integrity of dental restorations. This brings forth the need of a sensitive yet clinically applicable assessment method for interfacial debonding and demineralization. Optical coherence tomography (OCT) is an optical, nondestructive and clinically- applicable technique that uses near infra red-light waves to provide cross-sectional images of structures. It is regarded as a standard-of-care equipment in ophthalmology and its clinical application has recently expanded to cardiology and dermatology. In dentistry, it has been used intra-orally in clinical trials to detect and quantify enamel demineralization and to detect mucosal and submucosal lesions. Optical coherence tomography and has been used to assess the performance of dental adhesives in a 12-month in vivo trial on non-carious cervical lesion. The authors reported that OCT outcome measures detected significant differences between groups while visual assessments did not. Hence supplementing the two visual assessment techniques with OCT outcome measures is expected to increase the sensitivity of short term interfacial debonding and demineralization changes. The aim of the study is to compare the short-term marginal integrity of two preparation techniques for Class I composite restoration using two visual assessment techniques, the FDI World Dental Federation and US Public Health Service assessment criteria. In addition, Optical Coherence Tomography (OCT) will be used to assess the marginal integrity of the restoration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Composite with 90 degree cavosurface angleGroup 1: Lesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins |
| Group 2 | Experimental | Device: Composite with wide bevelLesion-specific cavity design with wide bevel throughout the cavity margins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Good general health
- Fair oral hygiene
- At least 20 teeth in occlusion
- Available for the duration of the study
- Participants with occlusal caries lesion/s in permanent posterior dentition except wisdom teeth
Key exclusion criteria (6 listed)
- Signs of bruxism
- Wisdom teeth
- Present with irreversible pulpitis.
- Periodontally compromised tooth that may require extraction.
- Caries lesions that would require cuspal coverage.
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 |
|---|---|---|
| Composite with 90 degree cavosurface angleLesion-specific cavity design with 90 degree cavosurface angle throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the preparation will be restored with a bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. | Device | Group 1 |
| Composite with wide bevelLesion-specific cavity design with wide bevel throughout the cavity margins will be prepared. The total etch method will be performed, i.e. with a 32% by weight phosphoric acid (3M Scotchbond™ Universal Etchant) on enamel and dentine for 15 seconds. The etchant will be rinsed away and an adhesive (3M Scotchbond™ Universal Adhesive) will be applied on dentine with a microbrush for 20 seconds. The adhesive will be light-cured for 10 sec with the Elipar S10 curing light (3M Oral Care). Subsequently the cavity will be restored in with a pre-warmed (using Bioclear Heatsync Kit) bulkfill resin composite (3M Filtek™ One Bulk Fill Restorative) and cured for 20 seconds. | Device | Group 2 |
Primary outcome
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline
Time frame: Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at baseline.
Marginal Staining: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Time frame: 6 months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 6 months post-operative.
Marginal Staining: World Dental Federation (FDI) Criteria - 18 Months Follow-up
Time frame: 18 months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal staining. 1. No marginal staining 2. Minor marginal staining, easily removable by polishing. 3. Moderate marginal staining, not esthetically unacceptable. 4. Pronounced marginal staining; major intervention necessary for improvement 5. Deep marginal staining, not accessible for intervention. Outcome will be reported as a single score at 18 months post-operative.
Marginal Staining: United States Public Health Service (USPHS) Criteria - Baseline
Time frame: Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at baseline.
Marginal Staining: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Time frame: 6 months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 6 months post-operative.
Marginal Staining: United States Public Health Service (USPHS) Criteria - 18 Months Follow-up
Time frame: 18 months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst staining. A) None. B) Superficial staining (removable, usually localized). C) Deep staining (not removable, generalized). Outcome will be reported as a single score at 18 months post-operative.
Marginal Defect: World Dental Federation (FDI) Criteria - Baseline
Time frame: Baseline
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Marginal Defect: World Dental Federation (FDI) Criteria - 6 Months Follow-up
Time frame: 6 months Follow-up
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Marginal Defect: World Dental Federation (FDI) Criteria - 18 Months Post-operative
Time frame: 18 months post-operative
The World Dental Federation (FDI) criteria is 5-point ordinal scale with a score of 5 indicating the worst marginal defect. 1. Harmonious outline, no gaps. 2. Slight ditching, slight step/flashes, minor irregularities. 3. Major irregularities, ditching or flash, steps 4. Larger irregularities or steps (repair necessary) 5. Generalized major gaps or irregularities. Margins were assessed quantitatively as 2 different proportions (100% and <100%) of the total length of the margin that is of Score 1 quality.
Marginal Defect: United States Public Health Service (USPHS) Criteria - Baseline
Time frame: Baseline
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at baseline.
Marginal Defect: United States Public Health Service (USPHS) Criteria - 6 Months Follow-up
Time frame: 6 months Follow-up
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 6 months post-operative.
Marginal Defect: United States Public Health Service (USPHS) Criteria - 18 Months Post-operative
Time frame: 18 months post-operative
The United States Public Health Service (USPHS) criteria is 3-point ordinal scale with the 'C' indicating the worst defect. A) Undetectable. B) Detectable - V-shaped defect in enamel only and catches explorer going both ways. C) Detectable - V-shaped defect to the dentin-enamel junction Outcome will be reported as a single score at 18 months post-operative.
3 secondary outcomes
Backscattered Intensity at the Occlusal Cavosurface Angle.
Time frame: Baseline
Tooth-resin Interface Gap at the Occlusal Cavosurface Angle.
Time frame: Baseline
Backscattered Intensity Along the Superficial 2mm Depth of the Preparation Walls
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20628774Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
- Background: PubMed 4515696Ryge G, Snyder M. Evaluating the clinical quality of restorations. J Am Dent Assoc. 1973 Aug;87(2):369-77. doi: 10.14219/jada.archive.1973.0421. No abstract available.
- Background: PubMed 23534012Nazari A, Sadr A, Shimada Y, Tagami J, Sumi Y. 3D assessment of void and gap formation in flowable resin composites using optical coherence tomography. J Adhes Dent. 2013 Jun;15(3):237-43. doi: 10.3290/j.jad.a28623.
Related trials for Cavity
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
Not yet recruiting
Clinical and 3D Evaluation of Injectable Versus Conventional Composite in Class V Restorations
Class V Dental Restorations
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingObservational study
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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.
Hooi Pin Chew, BDS, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Composite with 90 degree cavosurface angle and Composite with wide bevel in people with Cavity and Cavities of Teeth, run by University of Minnesota at 1 site in United States.
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 12 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: finished, as of the sponsor's last update on 28 Oct 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Marginal Staining: World Dental Federation (FDI) Criteria - Baseline (time frame: Baseline). The study lists 12 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 NCT05145322, which also lists 3 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 28 Oct 2024.