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

NCT05583682 | Completed

• 1 other identifier: RCT1103200802
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries in Children

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (2)

Nano-filled resin-modified glass ionomer restoration

EXPERIMENTAL

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

Sub-micron hybrid resin composite

EXPERIMENTAL

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

Interventions

Dental restoration OTHER

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

Nano-filled resin-modified glass ionomer restoration; Sub-micron hybrid resin composite

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacinlioglu, Nadya Marie: lead
• Yeditepe University: collaborator

Study Officials

• Nadya M Hacinlioglu-Ozpar, PhD

  Cyprus Health and Social Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Cyprus Health and Social Sciences University

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

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 18, 2022
• Study Start: May 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share