Clinical Performance of Glass Ionomer Versus Resin Composite Restorations

NCT ID: NCT04488380

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-12

Study Completion Date

2016-04-20

Brief Summary

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The aim of this randomised-controlled, single-blind, split-mouth, and single-centre clinical trial was to evaluate the 2-year clinical performances of a high-viscosity glass ionomer and nanohybrid composite resin in occlusal restorations on mandibular second molar teeth in patients at risk for salivary contamination.

Detailed Description

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Occlusal carious lesions on the right and left mandibular second molars of 56 patients (26 females, 30 males) were restored in a split-mouth design. A high-viscosity glass ionomer (Hv-GIC) (Equia, GC) was used to restore the carious lesions in patients in the treatment group, while a nano-hybrid composite resin (GSO) (GrandioSO, Voco) was used for patients in the control group. Clinical evaluations of the restorations were performed at 1-week, 6-month, 1-year, and 2-year follow-up appointments, according to the FDI criteria. Data were analysed using the Friedman's analysis of variance and Mann-Whitney U tests (α=0.05).

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One of the Glass ionomer restorative or Resin composite restorative materials were applied to carious mandibular 2nd molar teeth.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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high-viscosity glass ionomer restoration

One of the carious mandibular 2nd molar teeth (according to randomisation) will be restored with high-viscosity glass ionomer restoration (Equia, GC)

Group Type EXPERIMENTAL

dental restoration

Intervention Type OTHER

Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin

nano-hybrid composite resin

One of the carious mandibular 2nd molar teeth will be restored with nano-hybrid composite resin (GrandioSO, Voco)

Group Type EXPERIMENTAL

dental restoration

Intervention Type OTHER

Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin

Interventions

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dental restoration

Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* good health and oral hygiene,
* occlusal carious lesions on both mandibular second molars,
* mandibular second molars with mesial and occlusal contacts,
* contraindication to the use of rubber dam,
* the ability to return for periodic follow-up visits.

Exclusion Criteria

* restoration on mandibular second molars.
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Izmir Katip Celebi University

OTHER

Sponsor Role collaborator

Tokat Gaziosmanpasa University

OTHER

Sponsor Role lead

Responsible Party

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Huseyin Hatirli

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Gurgan S, Kutuk ZB, Yalcin Cakir F, Ergin E. A randomized controlled 10 years follow up of a glass ionomer restorative material in class I and class II cavities. J Dent. 2020 Mar;94:103175. doi: 10.1016/j.jdent.2019.07.013. Epub 2019 Jul 25.

Reference Type BACKGROUND
PMID: 31351909 (View on PubMed)

Turkun LS, Kanik O. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis? Oper Dent. 2016 Nov/Dec;41(6):587-598. doi: 10.2341/15-331-C. Epub 2016 Aug 29.

Reference Type BACKGROUND
PMID: 27571238 (View on PubMed)

Hatirli H, Yasa B, Celik EU. Clinical performance of high-viscosity glass ionomer and resin composite on minimally invasive occlusal restorations performed without rubber-dam isolation: a two-year randomised split-mouth study. Clin Oral Investig. 2021 Sep;25(9):5493-5503. doi: 10.1007/s00784-021-03857-0. Epub 2021 Mar 8.

Reference Type DERIVED
PMID: 33683465 (View on PubMed)

Other Identifiers

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Restorative Glass Ionomer

Identifier Type: -

Identifier Source: org_study_id

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