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

Study Overview
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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.

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.

Official Title
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Clinical Performance of Nano-filled Resin-modified Glass Ionomer and Sub-micron Hybrid Resin Composite Restorations in Permanent Molar Teeth:18-month Randomised Clinical Trial

Conditions
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Dental Caries in Children

Intervention / Treatment
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* Other: Dental restoration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with two comparable occlusal carious lesions on both mandibular first permanent molars. Neutral occlusion with a natural antagonist tooth Patients that are able to come to recalls Patients with a good oral hygiene Exclusion Criteria: Patients suffering systemic diseases or allergies Patients with gastrointestinal problems Mandibular first molar teeth with restorations Patients with oral habits Patients receiving orthodontic treatment Hypomineralized or Hypoplastic first molars

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One of the Nano-filled glass ionomer or sub-micron hybrid resin composite restorative materials were applied to carious mandibular first molar teeth
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano-filled resin-modified glass ionomer restoration<br>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) | Other: Dental restoration<br>* Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material<br>|
| Experimental: Sub-micron hybrid resin composite<br>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) | Other: Dental restoration<br>* Restoration of carious mandibular first molar teeth are restored either with nano-filled resin modified glass ionomer or sub-micron resin composite restorative material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Color Match | Color match of dental restorations were observed with a Vita Scale visually by two calibrated examiners. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. ( Alfa: Imperceptible in room light in one-second glance, Bravo: Perceptible mismatch with the Vita scale but clinically acceptable, Charlie: Esthetically unacceptable) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Marginal Discoloration | Marginal discoloration of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No existing marginal discoloration, Bravo:Presence of discoloration at margins between restoration and tooth structure; discoloration does not penetrate towards the pulp, Charlie: The discoloration penetrated along the margins of the restoration in a pulpal direction. | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Anatomic Form | Anatomic form of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: The restoration is not under-contoured, Bravo: The restoration is under-contoured, but there is no dentin or base exposed, Charlie: Sufficient restorative material is missing so that dentin or base is exposed. | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Marginal Integrity | Marginal integrity of dental restorations were observed by two calibrated examiners with visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No visible evidence of a crevice along the margin into which an explorer will catch, Bravo: The explorer catches a crevice along the margin but there is no exposure of dentin or base, Charlie: Visible evidence of a crevice with exposure of dentin or base.) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Recurrent Decay | Recurrent decay of dental restorations were observed by two calibrated examiners with visual inspection. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No evidence of recurrent caries along the margin of the restoration, Charlie: Evidence of caries along the margin of the restoration.) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Fracture | Fracture of dental restorations were observed by two calibrated examiners by visual inspection with explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: No fracture, Bravo: Small chip, but clinically acceptable, Charlie: Failure due to bulk restoration fracture.) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Surface Texture | Surface texture of dental restorations were observed by two calibrated examiners by visual inspection and explorer. Restorations were scored Alfa, Bravo or Charlie according to Modified USPHS criteria. (Alfa: Enamel like surface, Bravo: Surface rougher then enamel, clinically acceptable, Charlie: Surface unacceptable rough.) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 
| Postoperative Sensitivity | Postoperative sensitivity of patients were assessed by two calibrated examiners by cold thermal test. Restorations were scored Alfa or Charlie according to Modified USPHS criteria. (Alfa: No sensitivity, Charlie: Sensitivity present.) | Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nano-filled resin-modified glass ionomer, sub-micron hybrid resin composite, permanent molar teeth