Retrospective Evaluation of RMGI/GI Class V Restorations

Material, Dental Clinical Trial

Official title:

Retrospective Clinical Evaluation of RMGI/GI Class V Restorations Placed by Dental Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401618
• Other study ID #: 107864
• Status: Completed
• Start date: July 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2021
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Class V Ionomer restorations (RMGI and GIC) placed by 3rd and 4th dental students over the last three years.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Material, Dental

Intervention

Other:
• Retrospective evaluation of RMGI and GIC Class V Restorations
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.

Locations

Country	Name	City	State
Canada	Schulich Medicine and Dentistry - Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Franco 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. — View Citation

Imbery 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. — View Citation

Neo 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. — View Citation

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. Review. — View Citation

van 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. Epub 2005 Feb 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Primary	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)	2 years
Primary	Anatomic Form	Restoration's anatomy is continuous with existing anatomic form of remaining tooth structure (checked visually with a dental intra-oral mirror)	2 years
Primary	Color match	No difference between the tooth and restoration colour (checked visually with a dental intra-oral mirror)	2 years
Primary	Surface Roughness	Surface texture of the restoration is similar to tooth structure (manually checked with the tip of a dental hand instrument - explorer)	2 years
Primary	Marginal Discolouration	No visual evidence of dark discolouration adjacent to the margins of the restoration (checked visually with a dental intra-oral mirror)	2 years
Primary	Marginal Integrity	Restoration closely adapted to the tooth. No crevice visible (manually checked with the tip of a dental hand instrument - explorer)	2 years