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

NCT02991664 | Unknown DMC

• 1 other identifier: Equia Forte_G-aenial Posterior
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dental Caries Class II

Keywords

glass ionomer cement; composite resin

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Equia Forte, randomly applied

ACTIVE COMPARATOR

Placing glass ionomer restorations, the dentin and enamel of cavities were washed, and briefly dried. Equia Forte Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Forte Coat was applied and photocured for 20 seconds using a photo-curing light.

Other: Equia Forte

G-aenial Posterior, randomly applied

ACTIVE COMPARATOR

After etching procedure, the enamel and dentin were conditioned with G-aenial adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, G-aenial posterior composite resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.

Other: G-aenial Posterior

Interventions

Equia Forte OTHER

Glass ionomer restorative system

Also known as: Glass ionomer restorative system

Equia Forte, randomly applied

G-aenial Posterior OTHER

Micro hybrid composite resin

Also known as: Micro hybrid composite resin

G-aenial Posterior, randomly applied

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• a need for at least two but not more than four posterior toothcolored restorations;
• the presence of teeth to be restored in occlusion;
• teeth that were symptomless and vital;
• a normal periodontal status;
• a good likelihood of recall availability.

You may not qualify if:

• partly erupted teeth;
• absence of adjacent and antagonist teeth
• poor periodontal status;
• adverse medical history;
• potential behavioral problems.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University School of Dentistry

Ankara, 06100, Turkey (Türkiye)

Location

Related 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. Epub 2014 Oct 9.

  PMID: 25299703 RESULT

Study Officials

• Sevil Gurgan, Professor

  Hacettepe University School of Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: December 10, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2021
• Last Updated: December 13, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)