36-Month Clinical Performance of Different Restorative Materials in the Treatment of Root Caries Lesions

July 11, 2019 updated by: Uzay Koc, Hacettepe University

Clinical Performance of a Micro-hybride Resin Based Composite in the Treatment of Cervical Caries Lesions: 36-month, Split-mouth, Randomized Clinical Trial

This is a split-mouth, randomized clinical study that evaluating the 36-month performance of different restorative materials in the treatment of root caries lesions. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18,24 and 36 months according to the USPHS criteria.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of the study was to comparatively assess the 36-month clinical performance of a micro hybrid resin composite and resin-modified glass ionomer cement in root caries lesions.

Thirty-three patients with at least two root caries lesions participated in this study. A total of 110 restorations were randomly placed, half using resin composite (Spectrum TPH3) and the other half using the resin-modified glass ionomer cement (Riva Light Cure). Restorations were evaluated at the baseline, 6, 12, 18, 24 and 36 months. The data were analyzed with Pearson's Chi-square, Cochran's Q, Friedman tests and Logistic Regression Analysis (p=0.05).

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Root caries lesions (at least 1mm depth)

Exclusion Criteria:

  • Complex medical history
  • Poor dental hygiene/infrequent practise of oral hygiene habits
  • Severe or chronic periodontitis
  • Extreme carious activity
  • Heavy bruxism
  • Very deep (closer than 0.5 mm to the pulp) or superficial lesions (shallower than 1mm)
  • Previously restored and abutment teeth for bridge or removable dental prostheses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Spectrum TPH3, tooth restoration
Restoration with micro hybrid resin composite
Device: Spectrum TPH3
tooth restoration with two different restorative materials
Other Names:
  • resin composite
Device: Riva LC
tooth restoration with two different restorative materials
Other Names:
  • RMGİC
Active Comparator: Riva LC, restorative material
Restoration with resin-modified glass ionomer cement
Device: Spectrum TPH3
tooth restoration with two different restorative materials
Other Names:
  • resin composite
Device: Riva LC
tooth restoration with two different restorative materials
Other Names:
  • RMGİC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal adaptation 0 for at least 90% restorations (marginal adaption score)
Time Frame: 24 months

The primary factor for determining the clinical performance of a restorative material is the marginal adaption score. It represents the survival rates of the restorations after a period of time. According to ADA guidelines, a restorative material should show at least 90% survival rate after 18. The retention scored as 0 (restoration appears to adapt closely to the surface of the tooth with no crevice formation), 1 (an explorer caught lightly when run in both directions, and there was visible evidence of early crevice formation), 2 (an explorer got caught in both directions and penetrated a marginal crevice), 3 (the crevice had sufficient depth to expose the dentin, required replacement) or 4 (The restoration was fractured or lost).

Clinical evaluation is performed to examine if the restorations are in place or fallen.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Principal Investigator: Uzay Koc-Vural, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2016

Primary Completion (Actual)

July 15, 2018

Study Completion (Anticipated)

November 15, 2019

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 25, 2018

First Posted (Actual)

October 29, 2018

Study Record Updates

Last Update Posted (Actual)

July 15, 2019

Last Update Submitted That Met QC Criteria

July 11, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/03-23 (KA-16003)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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