Clinical Performance of a Glass-ionomer Restorative System in Extended-sized Cavities

Dental Caries Class II Clinical Trial

Official title:

Randomized, Controlled Trial of Glass Ionomer System vs Composite Posterior Restorations in Extended Sized Class 2 Cavities

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02991664
• Other study ID #: Equia Forte_G-aenial Posterior
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 10, 2016
• Last updated: December 10, 2016
• Start date: December 2015
• Est. completion date: December 2021

Study information

• Verified date: December 2016
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in extended sized class II cavities. A total of 100 class 2 lesions were restored with a glass ionomer restorative system (Equia Forte) or a micro hybrid composite (G-aenial Posterior). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p<0.05).

Description:

Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti-cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 2021
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. a need for at least two but not more than four posterior toothcolored restorations;

2. the presence of teeth to be restored in occlusion;

3. teeth that were symptomless and vital;

4. a normal periodontal status;

5. a good likelihood of recall availability.

Exclusion Criteria:

1. partly erupted teeth;

2. absence of adjacent and antagonist teeth

3. poor periodontal status;

4. adverse medical history;

5. potential behavioral problems.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries Class II

Intervention

Other:
• Equia Forte
Glass ionomer restorative system
• G-aenial Posterior
Micro hybrid composite resin

Locations

Country	Name	City	State
Turkey	Hacettepe University School of Dentistry	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Gurgan S, Kutuk ZB, Ergin E, Oztas SS, Cakir FY. Four-year randomized clinical trial to evaluate the clinical performance of a glass ionomer restorative system. Oper Dent. 2015 Mar-Apr;40(2):134-43. doi: 10.2341/13-239-C. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation.	Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1: Harmonious outline Alpha 2: Marginal gap (max 100µ) with discoloration (removable) Bravo: Marginal gap (> 100µ) with discoloration (unremovable) Charlie: The restoration is fractured or missed.	From baseline to 6 year the change of restorations was evaluated	Yes
Primary	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal discoloration.	Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth. Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth. Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.	From baseline to 6 year the change of restorations was evaluated	Yes
Primary	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate.	Retention rate was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C and D score means that the restoration has failed and needs to be replaced. Alpha 1:Clinically excellent Alpha 2: Clinically good with slight deviations from ideal performance, correction possible without damage of tooth or restoration Bravo: Clinically sufficient with few defects, corrections or repair of the restoration possible Charlie: Restoration is partially missed Delta: Restoration is totally missed	From baseline to 6 year the change of restorations was evaluated	Yes
Primary	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding anatomic form.	Anatomic form was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha 1: Continuous with existing anatomical form Alpha 2: Slightly discontinuous due to some chipping on the proximal ridge Bravo: Discontinuous with existing anatomical form due to material loss but proximal contact still present Charlie: Proximal contact is lost with ridge fracture.	From baseline to 6 year the change of restorations was evaluated	Yes
Primary	Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding color change	Colour changes was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failedand needs to be replaced. Alpha: The restoration matches the adjacent tooth structure in color and translucency. Bravo: Light mismatch in color, shade or translucency between the restoration and the adjacent tooth. Charlie: The mismatch in color and translucency is outside the acceptable range of tooth color and translucency.	From baseline to 6 year the change of restorations was evaluated	Yes