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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries in Children
• Intervention / Treatment: Other: Dental restoration

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Other: 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
Experimental: 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)	Other: 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hacinlioglu, Nadya Marie
• Collaborators: Yeditepe University
• Investigators: Principal Investigator: Nadya M Hacinlioglu-Ozpar, PhD, Cyprus Health and Social Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2008
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: nano-filled resin-modified glass ionomer; sub-micron hybrid resin composite; permanent molar teeth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: RCT1103200802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No