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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dental restoration

About this trial

This is an interventional treatment trial for Dental Caries in Children focused on measuring nano-filled resin-modified glass ionomer, sub-micron hybrid resin composite, permanent molar teeth

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Nano-filled resin-modified glass ionomer restoration

Sub-micron hybrid resin composite

Arm 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)

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)

Outcomes

Primary Outcome Measures

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)

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.

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.

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.)

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.)

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.)

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.)

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.)

Secondary Outcome Measures

Full Information

NCT ID

NCT05583682

First Posted

October 12, 2022

Last Updated

October 12, 2022

Sponsor

Hacinlioglu, Nadya Marie

Collaborators

Yeditepe University

1. Study Identification

Unique Protocol Identification Number

NCT05583682

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

May 1, 2008 (Actual)

Primary Completion Date

November 1, 2009 (Actual)

Study Completion Date

November 1, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacinlioglu, Nadya Marie

Collaborators

Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries in Children

Keywords

nano-filled resin-modified glass ionomer, sub-micron hybrid resin composite, permanent molar teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nano-filled resin-modified glass ionomer restoration

Arm Type

Experimental

Arm 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)

Arm Title

Sub-micron hybrid resin composite

Arm Type

Experimental

Arm 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)

Intervention Type

Other

Intervention Name(s)

Dental restoration

Intervention Description

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

Primary Outcome Measure Information:

Title

Color Match

Description

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)

Time Frame