Non-invasive Treatment of Root Caries in Older Adults

Root Caries Clinical Trial

— MIT-RCTalca  

Official title:

Non-invasive Therapy With Fluoridated Toothpastes for Root Caries in Independently-living Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647203
• Other study ID #: NI-RC PIEI-ES
• Secondary ID: 1140623
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 2014
• Est. completion date: December 21, 2018

Study information

• Verified date: December 2020
• Source: University of Talca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Background. Caries of the root surface (root caries) is the most prevalent type of dental caries in older adults with a reportedly worrisome trend to increase, as more teeth are being retained. Dental caries is the leading causes of tooth loss among older adults. Fluoride has been successfully used in preventive programs for root caries. In addition to preventing root caries, fluoride-based therapies may be used to treat lesions. This approach is known as non-invasive treatment. Fluoride seems to arrest and promote remineralization of the lesions. Indeed, recent studies appear to indicate that, higher fluoride concentrations are more effective to prevent and to treat the disease. Dentifrices with high concentrations of fluoride appear to be the most rational approach to prevent and treat root caries. To the chemical effect of fluoride, toothbrushing adds mechanical removal of the dental biofilm. High concentration fluoride varnishes have also been proposed as effective in treating carious lesions. Whether dentifrices, varnishes or the combined use of varnish and fluoridated toothpaste result more effective is a matter of controversy and it needs to be elucidated. Non-invasive treatment avoids the complications inherent to treating frail people in a dental setting, decrease costs and importantly, allows increased coverage, as these therapies may be delivered by non-dentist personnel. Although the appealing idea of non-invasive treatment of root caries in older adults, evidence is still limited and more research appears necessary to both, confirm clinical success and elucidate the mechanisms involved in lesion arrestment.

Aim. To determine the effectiveness of non-invasive therapies for root caries and their impact in the quality of life of older adults.

Methodology. A double blind randomized controlled trial (RCT) on independently-living older adults aged sixty or more years is proposed. Subjects will undergo clinical and microbiological examination when recruited (baseline) with a six-month follow-up regime until completion of two years. To participate, subjects will have to have at least five teeth with exposed root surfaces and one carious lesion. Sample size was calculated and a sample of two-hundred and eighty-eight older adults is necessary, randomized into two study arms;

Group 1: toothpaste 1.450 ppm F-

Group 2: toothpaste 5.000 ppm F-

Dependent variables. Root caries incidence and activity, cariogenic bacteria and oral health-related quality of life will be assessed upon completion of the study and compared with baseline scores.

Expected results. Based on some previous data available, it is expected that a non-invasive therapy for root caries based on low-fluoride concentration will be less effective than high fluoride therapies in inactivating root caries lesions. These results may be used in novel therapeutic programs at the community level, as well as in private practice. Furthermore, these studies will shed light on potential mechanisms associated with non-invasive treatment of root caries, from a microbiology stand point. Since a non-invasive approach decreases costs and increases coverage of dental care for older adults, these results may contribute to increase access to care for the usually vulnerable population of older adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: December 21, 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 60 + years old

• community-dwelling

• living in a community with fluoridated water

• had five or more of their own teeth

• with = 1 root caries lesion

Exclusion Criteria:

• cognitive impairment

• alcoholism

Related Conditions & MeSH terms

• Root Caries

Intervention

Drug:
• Self-administered fluoridated dentifrices
Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.

Locations

Country	Name	City	State
Chile	Faculty of Health Sciences	Talca	No State

Sponsors (2)

Lead Sponsor	Collaborator
University of Talca	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Chile, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Oral Health Related Quality of Life, Measured by the Oral Health Impact Profile (OHIP-14 Sp)	The impact on the quality of life of the therapy will be explored using the OHIP-14 Sp, validated by our group. In a scale ranging from 0 to 56 points, with 0-14 being good Oral Health-related quality of life and 15-56 poor Oral Health-related quality of life.	Data registered at 2 years of follow-up
Secondary	Salivary Flow	Unstimulated Salivary Flow, defined as Normal or Low Important: This outcome measure was originally considered. However, due to logistic issues, we did not assess it and no data is available.	Baseline and 2-year follow up

External Links

•   CEPAL (2013). Observatorio demográfico 2012. Proyecciones de población
•   MINSAL (2010). Guía Clínica: Salud Oral Integral del Adulto de 60 años
•   ONS (2013). Statistical bulletin: National Population Projections, 2012-based Statistical Bulletin