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Dental CariesEarly Phase 1NCT02604134

Medical Management of Caries in the Primary Dentition Using Silver Nitrate

A Early Phase 1 study testing Prophylaxis, Fluoride varnish and Silver Nitrate in people with Dental Caries, run by Arwa Owais at 1 site in United States.

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

This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations. Read more about this study

Who is it for?
Ages 2 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Dental Caries
What is being tested?
Prophylaxis, Fluoride varnish and Silver Nitrate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteUnited States
Study dates
Jul 2014to 21 Aug 2018
Phase
Early Phase 1
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 2 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
  • Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study

Who cannot join

  • Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
  • Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
  • Known allergy/sensitivity to any of the dental materials.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UIowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Medical Management of Caries in the Primary Dentition Using Silver Nitrate: A Pilot Study

This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.

Read the detailed description

This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.

Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.

Conditions
Dental Caries
Being tested
Prophylaxis, Fluoride varnish, Silver Nitrate
Keywords
silver nitrate, children, dental caries, medical management, quality of life
Medical subject headings
Dental Caries

What participants receive

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

  • ProphylaxisProcedure or surgery

    Also called Prophy

    A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.

  • Fluoride varnishDrug

    Also called Fluoride

    Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.

  • Silver NitrateDrug

    a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.

Study groups in NCT02604134
Study groupRoleWhat they receive
conventional treatment groupOtherThe child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire.
Receives: Procedure: Prophylaxis; Drug: Fluoride varnish
Silver Nitrate groupOtherThe child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire.
Receives: Procedure: Prophylaxis; Drug: Fluoride varnish; Drug: Silver Nitrate

What is being measured

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

  1. Change in baseline Caries Experience and activity (Incidence of caries in primary teeth)

    Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4

    Measured: through study completion, for 2 years

Secondary outcomes (1)

  1. Caries activity in primary teeth

    Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores.

    Measured: through study completion, for 2 years

Timeline

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

  1. First posted13 Nov 2015 (estimated)
  2. Study startJul 2014
  3. Primary completion24 Aug 2017
  4. Study completion21 Aug 2018

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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02604134
Sponsor's protocol ID
201406792
Status last verified
Jul 2019
First submitted
28 Oct 2015
Last updated
11 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8.

    PubMed 23270129

  • Klein U, Kanellis MJ, Drake D. Effects of four anticaries agents on lesion depth progression in an in vitro caries model. Pediatr Dent. 1999 May-Jun;21(3):176-80.

    PubMed 10355008

  • Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3.

    PubMed 22484380

  • Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.

    PubMed 26331379

  • Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28. No abstract available.

    PubMed 25987388

  • Keightley A, Clarkson J, Maguire A, Speed C, Innes N. Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers. Br Dent J. 2014 Nov;217(10):E22. doi: 10.1038/sj.bdj.2014.1009.

    PubMed 25415040

  • Santamaria R, Innes N. Trial shows partial caries removal is an effective technique in primary molars. Evid Based Dent. 2014 Sep;15(3):81-2. doi: 10.1038/sj.ebd.6401044.

    PubMed 25343394

  • Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.

    PubMed 25216660

  • Lamont T, Schwendicke F, Innes N. Why we need a core outcome set for trials of interventions for prevention and management of caries. Evid Based Dent. 2015 Sep;16(3):66-8. doi: 10.1038/sj.ebd.6401109. No abstract available.

    PubMed 26492796

  • Schwendicke F, Lamont T, Innes N. Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol. Trials. 2015 Sep 7;16:397. doi: 10.1186/s13063-015-0927-3.

    PubMed 26346538

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Prophylaxis, Fluoride varnish and Silver Nitrate in people with Dental Caries, run by Arwa Owais at 1 site in United States.

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 2 inclusion and 3 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 11 Jul 2019. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) (time frame: through study completion, for 2 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 NCT02604134, which also lists 10 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 11 Jul 2019.

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