Material, DentalNCT04401618
Retrospective Evaluation of RMGI/GI Class V Restorations
An observational study of Material, Dental, run by Western University, Canada at 1 site in Canada.
Trial summary
Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Material, Dental
- What is being tested?
- Retrospective evaluation of RMGI and GIC Class V Restorations
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students at the Schulich Dental Clinic over the last three years.
Who may be able to join
- Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.
Who cannot join
- Class V Restorations placed outside of the dental school
- Class V Restorations that used other restorative materials Class V Ionomer restorations (RMGI and GIC0 placed before three years on the time of evaluation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Schulich Medicine and Dentistry - Western University
London, Ontario, N6A5C1
About this study
Official title: Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students
Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students.
Read the detailed description
The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious cervical lesions restored by dental students. Ninety-six (96) restorations performed with either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS (United States Public Health Systems) criteria by two independent investigators at two follow-up evaluations (two years apart). The Fisher statistical test was used to compare USPHS criteria and examine significant differences by setting p<0.05 for statistical significance and the Kaplan-Meier algorithm was used to calculate the survival probability.
- Conditions
- Material, Dental
- Being tested
- Retrospective evaluation of RMGI and GIC Class V Restorations
- Keywords
- Glass-Ionomer Cement, Polyacid-Modified Composite Resin, Dental School
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective evaluation of RMGI and GIC Class V RestorationsOther
Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.
| Study group | Role | What they receive |
|---|---|---|
| Class V RMGI Restorations | Resin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes. Receives: Other: Retrospective evaluation of RMGI and GIC Class V Restorations | |
| Class V Glass ionomer - GIC Restorations | Glass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes. Receives: Other: Retrospective evaluation of RMGI and GIC Class V Restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Sensitivity
Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)
Measured: 2 years
Secondary Caries
No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)
Measured: 2 years
Anatomic Form
Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)
Measured: 2 years
Color match
No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)
Measured: 2 years
Surface Roughness
Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)
Measured: 2 years
Marginal Discolouration
No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)
Measured: 2 years
Marginal Integrity
Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study startJul 2016
- Primary completionAug 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Material, DentalStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jacinta Santos, Western University, Canada
- Investigators
- Maria Jacinta Santos, Ph.D, Principal investigator, Schulich Dentistry-Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401618
- Sponsor's protocol ID
- 107864
- Status last verified
- May 2021
- First submitted
- 14 May 2020
- Last updated
- 11 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.
PubMed 24671713Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.
PubMed 9002808Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.
PubMed 16924979van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.
PubMed 16005793Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.
PubMed 23088188
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students
- ClinicalTrials.gov ID
- NCT04401618
- Acronym / sponsor ID
- 107864
- Conditions
- Material, Dental
- Keywords
- Glass-Ionomer Cement, Polyacid-Modified Composite Resin, Dental School
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 May 2020 (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.
Brief Summary: Retrospective study to evaluate the clinical performance of two restorative materials - glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials - in Class V carious and non-carious cervical lesions restored by dental students.
Detailed description
The aim of this retrospective study was to evaluate the clinical performance of glass-ionomer (GI) and resin-modified glass-ionomer (RMGI) materials in Class V carious and non-carious cervical lesions restored by dental students. Ninety-six (96) restorations performed with either GI (Fuji IX) (n=39) or RMGI (Fuji II) (n=57) were evaluated using the modified USPHS (United States Public Health Systems) criteria by two independent investigators at two follow-up evaluations (two years apart). The Fisher statistical test was used to compare USPHS criteria and examine significant differences by setting p<0.05 for statistical significance and the Kaplan-Meier algorithm was used to calculate the survival probability.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Class V RMGI Restorations | – | Other: Retrospective evaluation of RMGI and GIC Class V RestorationsResin-modified glass ionomer (RMGI - Fuji 2 LC) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes. |
| Class V Glass ionomer - GIC Restorations | – | Other: Retrospective evaluation of RMGI and GIC Class V RestorationsGlass ionomer (GI - Fuji 9) Class V restorations performed by by 3rd and 4th-year dental students in adult patients of Schulich dental clinic over the last three years will be evaluated using mirrors and probes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults that have Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students at the Schulich Dental Clinic over the last three years.
Key inclusion criteria (1 listed)
- Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.
Key exclusion criteria (2 listed)
- Class V Restorations placed outside of the dental school
- Class V Restorations that used other restorative materials Class V Ionomer restorations (RMGI and GIC0 placed before three years on the time of evaluation.
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 |
|---|---|---|
| Retrospective evaluation of RMGI and GIC Class V RestorationsRetrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes. | Other | Class V Glass ionomer - GIC Restorations, Class V RMGI Restorations |
Primary outcome
Post-Operative Sensitivity
Time frame: 2 years
Absence of sensitivity to pressure, cold or hot temperature on the teeth restored (checked verbally by inquiring the patient about the presence or absence of pain in the presence of stimuli)
Secondary Caries
Time frame: 2 years
No visual evidence of dark, deep discolouration or cavitation adjacent to the restoration (visually and manually checked with the tip of a dental hand instrument - explorer)
Anatomic Form
Time frame: 2 years
Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)
Color match
Time frame: 2 years
No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)
Surface Roughness
Time frame: 2 years
Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)
Marginal Discolouration
Time frame: 2 years
No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)
Marginal Integrity
Time frame: 2 years
Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)
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 11 May 2021.
- Background: PubMed 24671713Santos MJ, Ari N, Steele S, Costella J, Banting D. Retention of tooth-colored restorations in non-carious cervical lesions--a systematic review. Clin Oral Investig. 2014;18(5):1369-81. doi: 10.1007/s00784-014-1220-7. Epub 2014 Mar 27.
- Background: PubMed 9002808Neo J, Chew CL, Yap A, Sidhu S. Clinical evaluation of tooth-colored materials in cervical lesions. Am J Dent. 1996 Feb;9(1):15-8.
- Background: PubMed 16924979Franco EB, Benetti AR, Ishikiriama SK, Santiago SL, Lauris JR, Jorge MF, Navarro MF. 5-year clinical performance of resin composite versus resin modified glass ionomer restorative system in non-carious cervical lesions. Oper Dent. 2006 Jul-Aug;31(4):403-8. doi: 10.2341/05-87.
- Background: PubMed 16005793van Dijken JW. Retention of a resin-modified glass ionomer adhesive in non-carious cervical lesions. A 6-year follow-up. J Dent. 2005 Aug;33(7):541-7. doi: 10.1016/j.jdent.2004.11.015. Epub 2005 Feb 8.
- Background: PubMed 23088188Imbery TA, Namboodiri A, Duncan A, Amos R, Best AM, Moon PC. Evaluating dentin surface treatments for resin-modified glass ionomer restorative materials. Oper Dent. 2013 Jul-Aug;38(4):429-38. doi: 10.2341/12-162-L. Epub 2012 Oct 22.
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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.
Maria Jacinta Santos, Ph.D principal investigator
Schulich Dentistry-Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Material, Dental, run by Western University, Canada at 1 site in Canada.
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 2 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 11 May 2021. 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 Canada. 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?
Post-Operative Sensitivity (time frame: 2 years). The study lists 7 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 NCT04401618, which also lists 5 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 11 May 2021.