Clinical trial NCT05583682: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Keywords: nano-filled resin-modified glass ionomer
sub-micron hybrid resin composite
permanent molar teeth
Lead sponsor: Hacinlioglu, Nadya Marie
Sponsor class: OTHER
Collaborators: name: Yeditepe University
First posted: 2022-10-18
Enrollment: 96
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 teeth
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Color Match
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Marginal Discoloration
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Anatomic Form
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Marginal Integrity
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Recurrent Decay
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Fracture
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Surface Texture
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
measure: Postoperative Sensitivity
timeFrame: Changes of dental restorations regarding color match were observed at 1st week, 6th,12th and 18th month recalls.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cyprus Health and Social Sciences University
name: Nadya M Hacinlioglu-Ozpar, PhD
role: PRINCIPAL_INVESTIGATOR
References: