NCT01417832

Brief Summary

The purpose of this study was to compare with a clinical randomized controlled split-mouth design study the changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
Last Updated

August 16, 2011

Status Verified

August 1, 2011

Enrollment Period

3.2 years

First QC Date

July 5, 2011

Last Update Submit

August 15, 2011

Conditions

Dental Caries

Keywords

Dental cariesProximal surfacesPreventive therapyDental radiographyTreatment efficacyYoung adults

Outcome Measures

Primary Outcomes (1)

  • Pair-wise radiographic lesion progression

    Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1, 2 and 3 years. The outcome was lesion progression, evaluated by radiographic techniques.

    1, 2, and 3 years

Secondary Outcomes (1)

  • Digital-subtraction radiography lesion progression

    1 year

Study Arms (2)

Treatment with Infiltrant/Adhesive

EXPERIMENTAL

In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.

Drug: Resin infiltration / adhesive

Placebo, placebo treatment

PLACEBO COMPARATOR

In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with a placebo treatment: At baseline one caries lesion was cleaned with a microbrush for 30 seconds and the procedure was repeated after two minutes.

Drug: Placebo

Interventions

Resin infiltration / adhesiveDRUG

Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.

Also known as: Infiltrant: Icon pre-product, DMG, Adhesive: Prime Bond NT, Dentsply
Treatment with Infiltrant/Adhesive
PlaceboDRUG

In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.

Also known as: Placebo (cleaning of surface)
Placebo, placebo treatment

Eligibility Criteria

Age16 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects were to have at least three caries proximal lesions on their posterior permanent teeth with a radiographic severity classification of the lesion score of 3 -Around the enamel dentin junction (EDJ) or 4 -Dentin-outer 1/3.

You may not qualify if:

  • Under orthodontic treatment at enrollment
  • Moving from the city (Bogota) in the following three years after commencing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad El Bosque

Bogotá, D.c:, 11001, Colombia

Location

Related Publications (4)

  • Martignon S, Ekstrand KR, Ellwood R. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography. Caries Res. 2006;40(5):382-8. doi: 10.1159/000094282.

    PMID: 16946605BACKGROUND

  • Martignon S, Tellez M, Santamaria RM, Gomez J, Ekstrand KR. Sealing distal proximal caries lesions in first primary molars: efficacy after 2.5 years. Caries Res. 2010;44(6):562-70. doi: 10.1159/000321986. Epub 2010 Nov 19.

    PMID: 21088401BACKGROUND

  • Ekstrand KR, Bakhshandeh A, Martignon S. Treatment of proximal superficial caries lesions on primary molar teeth with resin infiltration and fluoride varnish versus fluoride varnish only: efficacy after 1 year. Caries Res. 2010;44(1):41-6. doi: 10.1159/000275573. Epub 2010 Jan 15.

    PMID: 20090327BACKGROUND

  • Martignon S, Ekstrand KR, Gomez J, Lara JS, Cortes A. Infiltrating/sealing proximal caries lesions: a 3-year randomized clinical trial. J Dent Res. 2012 Mar;91(3):288-92. doi: 10.1177/0022034511435328. Epub 2012 Jan 17.

    PMID: 22257664DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

AdhesivesCMW cement

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Stefania Martignon, PhD

    Universidad El Bosque, Bogotá, COlombia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2011

First Posted

August 16, 2011

Study Start

January 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 16, 2011

Record last verified: 2011-08

Locations

CO(1)