Clinical Performance of Resin-modified Glass Ionomer and Composite Restorations in Permanent Teeth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-01

Study Completion Date

2009-11-01

Brief Summary

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The aim of this randomised controlled double-blinded, split mouth, single-center clinical trial was to evaluate the 18-month clinical performance of nano-filled resin-modified glass ionomer and sub-micron hybrid resin composite restorations in lower first permanent teeth of pediatric patients.

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Detailed Description

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Occlusal carious lesions on the left and right mandibular first molar teeth of 96 pediatric patients (54 female, 42 male) were restored in a split-mouth study design. Nano-filled resin-modified glass ionomer (Nano-RMGIC) (Ketac N 100, 3M/ESPE, USA) was used to restore the carious lesions for patients in the treatment group while a sub-micron hybrid resin composite (SpectrumTPH3, Dentsply, USA) was used for patients in the control group. Clinical evaluation of restorations were performed at the 1st week, 6th, 12th and 18th month recalls by two calibrated examiners according to the Modified-USPHS criteria.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One of the Nano-filled glass ionomer or sub-micron hybrid resin composite restorative materials were applied to carious mandibular first molar teeth

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nano-filled resin-modified glass ionomer restoration

One of the carious mandibular first molar teeth will be restored according to randomisation with nano-filled resin-modified glass ionomer restorative material (Ketac N 100/3M ESPE, USA)

Group Type EXPERIMENTAL

Dental restoration

Intervention Type OTHER

Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material

Sub-micron hybrid resin composite

One of the carious mandibular first molar teeth will be restored according to randomisation with sub-micron hybrid resin composite restorative material (Spectrum TPH3, Dentsply Caulk, USA)

Group Type EXPERIMENTAL

Dental restoration

Intervention Type OTHER

Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material

Interventions

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Dental restoration

Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients with two comparable occlusal carious lesions on both mandibular first permanent molars.
2. Neutral occlusion with a natural antagonist tooth
3. Patients that are able to come to recalls
4. Patients with a good oral hygiene

Exclusion Criteria

1. Patients suffering systemic diseases or allergies
2. Patients with gastrointestinal problems
3. Mandibular first molar teeth with restorations
4. Patients with oral habits
5. Patients receiving orthodontic treatment
6. Hypomineralized or Hypoplastic first molars

Minimum Eligible Age

7 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes