NCT04804423

Brief Summary

This observational cohort study aims to evaluate the short-term (3 months) efficacy of the standard fluoride therapy in the German National Health System for managing hypersensitive carious lesions in primary teeth (fluoride varnish application), and further compare it to a different fluoride therapy utilizing a silver-containing fluoride agent combined with potassium iodide solution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2020

Shorter than P25 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 13, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

March 4, 2021

Last Update Submit

May 5, 2021

Conditions

Dentin HypersensitivityActive Dental Caries

Outcome Measures

Primary Outcomes (1)

  • Hypersensitivity pain relief

    The degree of pain severity will be quantified by a visual analogue scale - VAS; 0-10, ranging across a continuum from none (0) to a severe amount of pain (10).

    3 Months

Secondary Outcomes (3)

  • Activity of carious lesions

    3 Months

  • Patient Acceptance

    Only at baseline (begining, during and after procedure)

  • Operating Dentists' Opinion About the Procedure Performed

    Will be recorded immediately after the procedure

Other Outcomes (1)

  • O'Leary Plaque Control Index

    3 Months

Study Arms (2)

Fluoride varnish (Duraphat®)

ACTIVE COMPARATOR

Fluoride varnish application is recommended by the German National Health System for managing hypersensitivity and dental caries. Sodium fluoride varnish (Duraphat®) will be applied on hypersensitive active carious lesions (ICDAS 5).

Drug: Sodium fluoride varnish (generic name; Duraphat®)

Silver fluoride and potassium iodide (Riva Star®)

EXPERIMENTAL

Silver fluoride and potassium iodide (Riva Star®) is primarily indicated for relieving hypersensitivity will be applied on hypersensitive active carious lesions (ICDAS 5) following isolation of the affected teeth and according to manufacturer's instructions.

Drug: 38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)

Interventions

38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)DRUG

38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.

Also known as: Riva Star®
Silver fluoride and potassium iodide (Riva Star®)
Sodium fluoride varnish (generic name; Duraphat®)DRUG

22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.

Also known as: Duraphat®
Fluoride varnish (Duraphat®)

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Reported hypersensitivity in primary teeth associated with the presence of active carious lesions (ICDAS 5).
  • Healthy children aged 2-5 years.
  • Not using any desensitizer for 1-month prior the study.
  • Willing to be examined.

You may not qualify if:

  • Previously restored teeth.
  • Teeth with signs or symptoms of irreversible pulpitis.
  • Patients with any systemic disease requiring special considerations during their dental treatment.
  • Parents/children who declined to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Department of Preventive and Pediatric Dentistry, University of Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (9)

  • West N, Seong J, Davies M. Dentine hypersensitivity. Monogr Oral Sci. 2014;25:108-22. doi: 10.1159/000360749. Epub 2014 Jun 26.

    PMID: 24993261BACKGROUND

  • Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.

    PMID: 28457477BACKGROUND

  • Use of Silver Diamine Fluoride for Dental Caries Management in Children and Adolescents, Including Those with Special Health Care Needs. Pediatr Dent. 2018 Oct 15;40(6):152-161.

    PMID: 32074885BACKGROUND

  • Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.

    PMID: 26831727BACKGROUND

  • Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.

    PMID: 31590168BACKGROUND

  • Poulsen S, Errboe M, Hovgaard O, Worthington HW. Potassium nitrate toothpaste for dentine hypersensitivity. Cochrane Database Syst Rev. 2001;(2):CD001476. doi: 10.1002/14651858.CD001476.

    PMID: 11405992BACKGROUND

  • Splieth CH, Tachou A. Epidemiology of dentin hypersensitivity. Clin Oral Investig. 2013 Mar;17 Suppl 1(Suppl 1):S3-8. doi: 10.1007/s00784-012-0889-8. Epub 2012 Dec 7.

    PMID: 23224064BACKGROUND

  • Santamaria RM, Innes NPT, Machiulskiene V, Schmoeckel J, Alkilzy M, Splieth CH. Alternative Caries Management Options for Primary Molars: 2.5-Year Outcomes of a Randomised Clinical Trial. Caries Res. 2017;51(6):605-614. doi: 10.1159/000477855. Epub 2017 Dec 20.

    PMID: 29258064BACKGROUND

  • Santamaria RM, Abudrya MH, Gul G, Mourad MS, Gomez GF, Zandona AGF. How to Intervene in the Caries Process: Dentin Caries in Primary Teeth. Caries Res. 2020;54(4):306-323. doi: 10.1159/000508899. Epub 2020 Aug 27.

    PMID: 32854105BACKGROUND

Related Links

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

silver fluoridesodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Mohamed H Abudrya, BDS, MSc.

    The Department of Preventive and Pediatric Dentistry, University of Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 18, 2021

Study Start

January 13, 2020

Primary Completion

March 31, 2021

Study Completion

April 1, 2021

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)