NCT02647203

Brief Summary

This study aims to test the effectiveness in reducing or arresting root caries lesion in community-dwelling elderly subjects by using high fluoridated toothpaste. A double blinded RCT will be conducted with two arms; 5000 ppm F and 1450 ppm F toothpaste. Dentifrices will be delivered to the participants in a blind format and they will be instructed to brush twice per day. Follow-up will be carries out every 6 months for two years to assess:

  • Root caries incidence.
  • Lesion arresting
  • Changes in salivary flow
  • Microbiology pattern shift
  • Variations in oral health- related quality of life by OHIP-14 Sp

Trial Health

87
On Track

Trial Health Score

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

Enrollment
345

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1

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

July 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 5, 2021

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

December 7, 2015

Results QC Date

November 3, 2018

Last Update Submit

December 28, 2023

Conditions

Root Caries

Keywords

Fluoride toothpasteRoot cariesRandomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Root Caries Activity

    Using Nyvad's criteria for root caries lesions, activity will be assessed by a visual-tactile method.

    After 2 years of follow up

Secondary Outcomes (2)

  • Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)

    Data registered at 2 years of follow-up

  • Salivary Flow

    Baseline and 2-year follow up

Study Arms (2)

High Fluoride Toothpaste

EXPERIMENTAL

5,000 ppm fluoridated toothpaste, high concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)

Drug: Self-administered fluoridated dentifrices

Standard Fluoride Toothpaste

ACTIVE COMPARATOR

1,450 ppm fluoridated toothpaste, low concentration. Self-administered fluoridated dentifrices. By the elderly subjects, twice per day Drug (including placebo)

Drug: Self-administered fluoridated dentifrices

Interventions

Self-administered fluoridated dentifricesDRUG

Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.

Also known as: Toothbrushing with high and standard fluoride dentifrices
High Fluoride ToothpasteStandard Fluoride Toothpaste

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + years old
  • community-dwelling
  • living in a community with fluoridated water
  • had five or more of their own teeth
  • with ≥ 1 root caries lesion

You may not qualify if:

  • cognitive impairment
  • alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences

Talca, No State, 3460000, Chile

Location

Related Publications (10)

  • Ekstrand K, Martignon S, Holm-Pedersen P. Development and evaluation of two root caries controlling programmes for home-based frail people older than 75 years. Gerodontology. 2008 Jun;25(2):67-75. doi: 10.1111/j.1741-2358.2007.00200.x. Epub 2008 Jan 13.

    PMID: 18194330BACKGROUND

  • Ekstrand KR, Poulsen JE, Hede B, Twetman S, Qvist V, Ellwood RP. A randomized clinical trial of the anti-caries efficacy of 5,000 compared to 1,450 ppm fluoridated toothpaste on root caries lesions in elderly disabled nursing home residents. Caries Res. 2013;47(5):391-8. doi: 10.1159/000348581. Epub 2013 Apr 9.

    PMID: 23594784BACKGROUND

  • Gluzman R, Katz RV, Frey BJ, McGowan R. Prevention of root caries: a literature review of primary and secondary preventive agents. Spec Care Dentist. 2013 May-Jun;33(3):133-40. doi: 10.1111/j.1754-4505.2012.00318.x. Epub 2012 Dec 10.

    PMID: 23600985BACKGROUND

  • Griffin SO, Griffin PM, Swann JL, Zlobin N. Estimating rates of new root caries in older adults. J Dent Res. 2004 Aug;83(8):634-8. doi: 10.1177/154405910408300810.

    PMID: 15271973BACKGROUND

  • Griffin SO, Regnier E, Griffin PM, Huntley V. Effectiveness of fluoride in preventing caries in adults. J Dent Res. 2007 May;86(5):410-5. doi: 10.1177/154405910708600504.

    PMID: 17452559BACKGROUND

  • Holmgren C, Gaucher C, Decerle N, Domejean S. Minimal intervention dentistry II: part 3. Management of non-cavitated (initial) occlusal caries lesions--non-invasive approaches through remineralisation and therapeutic sealants. Br Dent J. 2014 Mar;216(5):237-43. doi: 10.1038/sj.bdj.2014.147.

    PMID: 24603245BACKGROUND

  • Ritter AV, Shugars DA, Bader JD. Root caries risk indicators: a systematic review of risk models. Community Dent Oral Epidemiol. 2010 Oct;38(5):383-97. doi: 10.1111/j.1600-0528.2010.00551.x.

    PMID: 20545716BACKGROUND

  • Walls AW, Meurman JH. Approaches to caries prevention and therapy in the elderly. Adv Dent Res. 2012 Sep;24(2):36-40. doi: 10.1177/0022034512453590.

    PMID: 22899677BACKGROUND

  • Leon S, Bravo-Cavicchioli D, Correa-Beltran G, Giacaman RA. Validation of the Spanish version of the Oral Health Impact Profile (OHIP-14Sp) in elderly Chileans. BMC Oral Health. 2014 Aug 4;14:95. doi: 10.1186/1472-6831-14-95.

    PMID: 25091189RESULT

  • Leon S, Gonzalez K, Hugo FN, Gambetta-Tessini K, Giacaman RA. High fluoride dentifrice for preventing and arresting root caries in community-dwelling older adults: A randomized controlled clinical trial. J Dent. 2019 Jul;86:110-117. doi: 10.1016/j.jdent.2019.06.002. Epub 2019 Jun 6.

    PMID: 31176788DERIVED

Related Links

MeSH Terms

Conditions

Root Caries

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Results Point of Contact

Title
Dr. Rodrigo Giacaman
Organization
University of Talca
giacaman@utalca.cl
+56712201546

Study Officials

  • Rodrigo A Giacaman, DDS, PhD

    University of Talca

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
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
Associate Professor

Study Record Dates

First Submitted

December 7, 2015

First Posted

January 6, 2016

Study Start

July 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 21, 2018

Last Updated

January 2, 2024

Results First Posted

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)