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Dental CariesPhase 2/3NCT01417832

Radiographic Progression of Sealed and Infiltrated Caries Lesions in Vivo

A Phase 2/3 study testing Resin infiltration / adhesive in people with Dental Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years
Conditions the study is for
Dental Caries
What is being tested?
Resin infiltration / adhesive
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
1 siteColombia
Study dates
Jan 2008to Mar 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • Universidad El Bosque

    Bogotá, D.c:, 11001

Other trials in Colombia

About this study

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.

Read the detailed description

Fissure sealing has been shown to inhibit not only the formation of occlusal caries but also to impede the progression of existing caries lesions. Lately, the concept of sealing caries to arrest lesion progression has been transferred to approximal surfaces. In a clinical study sealed approximal lesions showed significantly reduced progression after 18 month compared with those that were treated only with preventive measures.

The pores of enamel caries lesions provide diffusion pathways for acids and dissolved minerals. The aim of caries infiltration is to occlude these pores by infiltration with light curing resins in order to block the diffusion of acids into the lesion body. In contrast to caries sealing, caries infiltration aims to occlude the pores within the lesion rather then placing a diffusion barrier on the lesion surface. Several studies showed significantly reduced progression of infiltrated enamel lesions in demineralizing environments.

This split-mouth placebo-controlled randomized clinical trial was conducted on 16-35 year-old subjects in Bogotá, Colombia (IRB UB.162-2008).

The sample size calculated was of minimum 29 patients with 3 approximal lesions around the EDJ or in the dentin outer third.

The study population was students and patients from Unversidad El Bosque. Two visits were planned for the patients within same week. In the first visit baseline standardized bitewing radiographs were obtained and 3 proximal selected lesions were randomly selected. A clinical examination was conducted to assess DMF-T/S, and individual caries risk. Elastic orthodontic bands were placed between teeth of selected surfaces for elective temporary separation.

In the second visit selected lesions were visually classified with ICDAS criteria and activity status of lesions was assessed. The 3 lesions were randomly allocated to: A. Infiltration, B. Sealing, C. Placebo, and lesions were treated.

Subjects were clinically examined after one, two, and three years by two examiners (AC, JSL) blinded to the selected treatment groups and referral for operative treatment were done if needed. Standardized bitewing radiographs were made each year.

Lesions progression was assessed on radiographs by pair-wise reading by an external examiner blinded to groups. Additionally, after one year reading of images was conducted by digital-subtraction radiography of scanned images. For reproducibility assessment the examiner repeated 20% of radiograph readings by both methods one week after the first reading.

Statistical analysis Intra-examiner reliability for radiographs readings was assessed by unweighted kappa scores; caries experience (DMF-T/S), individual caries risk levels, ICDAS criteria, radiographic scores, and progression' status of selected lesions were reported descriptively.

The outcome variable of changes in lesion progression after 1, 2 and 3 years was assessed by pair-wise radiographic reading and after one year also by digital-subtraction radiography.

Differences in lesion progression between treatments at each follow-up were tested by the Cochran Q test and in case of significant difference between groups, by the McNemar Change test, including the therapeutic effect and the 95% confidence intervals [Siegel \& Castellan, 1988].

In all tests p-values less than 0.05 were considered significant.

Conditions
Dental Caries
Being tested
Resin infiltration / adhesive, Placebo
Keywords
Dental caries, Proximal surfaces, Preventive therapy, Dental radiography, Treatment efficacy, Young adults
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resin infiltration / adhesiveDrug

    Also called Infiltrant: Icon pre-product, DMG, Adhesive: Prime Bond NT, Dentsply

    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.

  • PlaceboDrug

    Also called Placebo (cleaning of surface)

    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.

Study groups in NCT01417832
Study groupRoleWhat they receive
Treatment with Infiltrant/AdhesiveExperimentalIn 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.
Receives: Drug: Resin infiltration / adhesive
Placebo, placebo treatmentPlacebo comparatorIn 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1, 2, and 3 years

Secondary outcomes (1)
  1. Digital-subtraction radiography lesion progression

    Changes in the therapeutic effect of infiltrating versus sealing proximal caries lesions and placebo treatment after 1 year. The outcome was lesion progression, evaluated by subtraction radiography.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startJan 2008
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417832
Sponsor's protocol ID
DOC_20080328131018
Status last verified
Aug 2011
First submitted
5 Jul 2011
Last updated
16 Aug 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16946605
  • 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.

    PubMed 21088401
  • 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.

    PubMed 20090327
  • 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.

    PubMed 22257664

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Resin infiltration / adhesive in people with Dental Caries, run by Universidad El Bosque, Bogotá at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pair-wise radiographic lesion progression (time frame: 1, 2, and 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01417832, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.

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