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Completed

NCT Number: NCT05583682

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

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.

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Key information

Conditions

Dental Caries in Children

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Color Match

    Time frame: 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)

  2. Marginal Discoloration

    Time frame: 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.

  3. Anatomic Form

    Time frame: 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.

  4. Marginal Integrity

    Time frame: 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.)

  5. Recurrent Decay

    Time frame: 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.)

  6. Fracture

    Time frame: 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.)

  7. Surface Texture

    Time frame: 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.)

  8. Postoperative Sensitivity

    Time frame: 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.)

Sponsors and collaborators

Lead sponsor

Hacinlioglu, Nadya Marie

Other

Collaborators

  • Yeditepe University

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 18, 2022
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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