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

Sponsor

Hacinlioglu, Nadya Marie (Other)

Overall Status

Completed

CT.gov ID

NCT05583682

Collaborator

Yeditepe University (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries in Children	Other: Dental restoration	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Color Match [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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 [Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.]
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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hacinlioglu, Nadya Marie
Yeditepe University

Investigators

Principal Investigator: Nadya M Hacinlioglu-Ozpar, PhD, Cyprus Health and Social Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nadya Marie Hacinlioglu, Associate Professor, Cyprus Health and Social Sciences University, Hacinlioglu, Nadya Marie

ClinicalTrials.gov Identifier:

NCT05583682

Other Study ID Numbers:

RCT1103200802

First Posted:

Oct 18, 2022

Last Update Posted:

Oct 18, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nadya Marie Hacinlioglu, Associate Professor, Cyprus Health and Social Sciences University, Hacinlioglu, Nadya Marie

nano-filled resin-modified glass ionomer

sub-micron hybrid resin composite

permanent molar teeth

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Oct 18, 2022