NCT02267720

Brief Summary

The aim of this research is to investigate the survival rate and cost effectiveness of two brands of GIC as occlusal-proximal ART restorations. Also the survival rate of the tooth will be investigated.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

4 months

First QC Date

October 14, 2014

Last Update Submit

September 22, 2015

Conditions

Dental Caries

Keywords

Dental Atraumatic Restorative TreatmentGlass ionomer cementOcclusal-proximal leasonsPrimary molars

Outcome Measures

Primary Outcomes (3)

  • Survival rate of ART occluso-proximal restoration

    Every 6 months up to 2 years

  • Survival rate of primary molar after ART restoration

    Every 6 months up to exfoliation of the tooth

  • Cost effectiveness of two brands of GIC in occluso-proximal ART restorations

    After 2 years

Secondary Outcomes (7)

  • Relation between approximal contact and survival rate

    After 2 years

  • Relation between ICDAS adjacent tooth and survival rate

    After 2 years

  • Relation between occlusal contact and survival rate

    After 2 years

  • Difference between the two operators

    After 2 years

  • Relation between contamination and survival rate

    After 2 years

  • +2 more secondary outcomes

Study Arms (2)

Ketac Molar

ACTIVE COMPARATOR

Occlusal-proximal ART restorations - Ketac Molar

Procedure: Occlusal-proximal ART restorations - Vitro Molar

Vitro Molar

EXPERIMENTAL

Occlusal-proximal ART restorations - Vitro Molar

Procedure: Occlusal-proximal ART restorations - Ketac Molar

Interventions

Occlusal-proximal ART restorations - Ketac MolarPROCEDURE

Occlusal-proximal ART restorations - Ketac Molar

Vitro Molar
Occlusal-proximal ART restorations - Vitro MolarPROCEDURE

Occlusal-proximal ART restorations - Vitro Molar

Ketac Molar

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- the presence of at least one occluso-proximal carious lesion in a primary molar reaching dentin, but no larger than 2mm mesio-distal, 2.5mm bucco-lingual and occluso-cervical.

You may not qualify if:

  • cases of pulp exposure, non-cooperative behaviour, pain, mobility, swelling, fistula or a lesion that cannot be cleaned with hand instruments, and absence of an adjacent tooth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 22891625RESULT

  • 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: 23190278RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Daniela P Raggio, prof.

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Paediatric Dentistry

Study Record Dates

First Submitted

October 14, 2014

First Posted

October 17, 2014

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2017

Last Updated

September 24, 2015

Record last verified: 2015-09