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

Hacinlioglu, Nadya Marie

Status: Completed

Conditions: Dental Caries in Children

Treatments: Other: Dental restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT05583682

RCT1103200802

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 2 patient groups

Nano-filled resin-modified glass ionomer restoration

Experimental group

Description:

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)

Treatment:

Other: Dental restoration

Sub-micron hybrid resin composite

Experimental group

Description:

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)

Treatment:

Other: Dental restoration