The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

NCT02217098 | Completed

• 1 other identifier: FOUSP6808912
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief Summary

The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions. This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.

Conditions

Caries Involving Multiple Surfaces of Tooth; Dental Caries on Chewing Surface of Tooth; Dental Caries Extending Into Dentine

Keywords

ART; Occlusal; Occlusoproximal; Primary teeth

Outcome Measures

Primary Outcomes (1)

• Survival rate (longevity) of ART restorations using differents materials

  The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and occlusoproximal caries in primary molars with ART under field conditions.

  6, 12, 24 and 36 months follow-up

Secondary Outcomes (6)

• Association between survival and gender

  6, 12, 24 and 36 months follow-up

• Association between survival and DMFT (caries experience)

  6, 12, 24 and 36 months follow-up

• Association between survival and occlusal contact after restoration

  6, 12, 24 and 36 months follow-up

• Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)

  6, 12, 24 and 36 months follow-up

• Cost-effectiveness of the 3 materials and their association with survival rate

  6, 12, 24 and 36 months follow-up

Study Arms (3)

GIC Restorations

ACTIVE COMPARATOR

Restorations using Glass Ionomer Cement

Procedure: GIC Restorations

Compomer Restorations

EXPERIMENTAL

Restorations using Compomer

Procedure: Compomer Restorations

Carbomer Restorations

EXPERIMENTAL

Restorations using Glass Carbomer

Procedure: Carbomer Restorations

Interventions

GIC Restorations PROCEDURE

Restorations using Glass Ionomer Cement

GIC Restorations

Carbomer Restorations PROCEDURE

Restorations using Glass Carbomer

Carbomer Restorations

Compomer Restorations PROCEDURE

Restorations using Compomer

Compomer Restorations

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children, age: 4-8 years
• At least one occlusal or proximal carious lesion in primary molar involving dentin
• Cooperative behavior
• Presence of antagonist of the tooth
• Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm
• Absence of tooth mobility and abscess or fistula near to the selected tooth

You may not qualify if:

• Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research.

Sponsors & Collaborators

• Daniela Prócida Raggio: lead
• Academic Centre for Dentistry in Amsterdam: collaborator

Study Sites (1)

School of Dentistry - Sao Paulo University

São Paulo, 05508-000, Brazil

Location

Related Publications (14)

• Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.

  PMID: 22891625 BACKGROUND

• de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.

  PMID: 21274581 BACKGROUND

• Banerjee A, Kidd EA, Watson TF. In vitro evaluation of five alternative methods of carious dentine excavation. Caries Res. 2000 Mar-Apr;34(2):144-50. doi: 10.1159/000016582.

  PMID: 10773632 BACKGROUND

• van Bochove JA, van Amerongen WE. The influence of restorative treatment approaches and the use of local analgesia, on the children's discomfort. Eur Arch Paediatr Dent. 2006 Mar;7(1):11-6. doi: 10.1007/BF03320809.

  PMID: 17140522 BACKGROUND

• Carvalho TS, van Amerongen WE, de Gee A, Bonecker M, Sampaio FC. Shear bond strengths of three glass ionomer cements to enamel and dentine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e406-10. doi: 10.4317/medoral.16.e406.

  PMID: 20526266 BACKGROUND

• Cehreli SB, Tirali RE, Yalcinkaya Z, Cehreli ZC. Microleakage of newly developed glass carbomer cement in primary teeth. Eur J Dent. 2013 Jan;7(1):15-21.

  PMID: 23408469 BACKGROUND

• Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.

  PMID: 22124610 BACKGROUND

• van Duinen RN, Kleverlaan CJ, de Gee AJ, Werner A, Feilzer AJ. Early and long-term wear of 'fast-set' conventional glass-ionomer cements. Dent Mater. 2005 Aug;21(8):716-20. doi: 10.1016/j.dental.2004.09.007.

  PMID: 16026667 BACKGROUND

• Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.

  PMID: 17082278 BACKGROUND

• Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.

  PMID: 8915958 BACKGROUND

• Kuhnisch J, Mansmann U, Heinrich-Weltzien R, Hickel R. Longevity of materials for pit and fissure sealing--results from a meta-analysis. Dent Mater. 2012 Mar;28(3):298-303. doi: 10.1016/j.dental.2011.11.002. Epub 2011 Dec 3.

  PMID: 22137936 BACKGROUND

• Mickenautsch S, Mount G, Yengopal V. Therapeutic effect of glass-ionomers: an overview of evidence. Aust Dent J. 2011 Mar;56(1):10-5; quiz 103. doi: 10.1111/j.1834-7819.2010.01304.x.

  PMID: 21332735 BACKGROUND

• Raggio DP, Hesse D, Lenzi TL, Guglielmi CA, Braga MM. Is Atraumatic restorative treatment an option for restoring occlusoproximal caries lesions in primary teeth? A systematic review and meta-analysis. Int J Paediatr Dent. 2013 Nov;23(6):435-43. doi: 10.1111/ipd.12013. Epub 2012 Nov 28.

  PMID: 23190278 BACKGROUND

• Olegario IC, Hesse D, Mendes FM, Bonifacio CC, Raggio DP. Glass carbomer and compomer for ART restorations: 3-year results of a randomized clinical trial. Clin Oral Investig. 2019 Apr;23(4):1761-1770. doi: 10.1007/s00784-018-2593-9. Epub 2018 Aug 31.

  PMID: 30171345 DERIVED

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Daniela P Raggio, Professor

  Universidade de Sao Paulo - Faculdade de Odontologia

  PRINCIPAL INVESTIGATOR

• Isabel O Costa, PhD

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associated Professor of Paediatric Dentistry

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: August 15, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: September 10, 2018
• Last Updated: November 21, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)