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

Dental Caries in Children Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05583682
• Other study ID #: RCT1103200802
• Status: Completed
• Phase: N/A
• Start date: May 1, 2008
• Est. completion date: November 1, 2009

Study information

• Verified date: October 2022
• Source: Hacinlioglu, Nadya Marie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: November 1, 2009
• Est. primary completion date: November 1, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hacinlioglu, Nadya Marie	Yeditepe University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.