Fluoride Varnish Randomized Clinical Trial

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Completed
• CT.gov ID: NCT00066963
• Collaborator: (none)
• Enrollment: 376
• Location: 1
• Arms: 3
• Duration (Months): 50
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Fluoride Varnish	Phase 3

Detailed Description

This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.

Study Design

• Study Type: Interventional
• Actual Enrollment: 376 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes
• Study Start Date: Oct 1, 2002
• Actual Primary Completion Date: Nov 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Counseling Only Counseling Only
Experimental: FV every 12mo for 24mo + Counsel Preventive fluoride varnish every 12mo for 24mo plus Counseling	Device: Fluoride Varnish; 0.1 mL (1 drop) applied on each of 2 arches; Other Names: Duraphat® (Colgate Oral Pharmaceuticals)
Experimental: FV every 6mo for 24mo + Counseling Preventive fluoride varnish every 6mo for 24mo plus Counseling	Device: Fluoride Varnish; 0.1 mL (1 drop) applied on each of 2 arches; Other Names: Duraphat® (Colgate Oral Pharmaceuticals)

Outcome Measures

Primary Outcome Measures

1. Number of Caries Incident Cases [two years]

   A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion

• Children < 44 months old

• Caries-free

• 4 erupted maxillary incisors

• Residing in fluoridated community (San Francisco)

Exclusion

• Cleft Palate

• Developmental or learning disabilities

• Children with transient residence (homeless, migrant, foster home)

• Children with an another household member participating in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSF School of Dentistry	San Francisco	California	United States	94143-1361

Sponsors and Collaborators

• University of California, San Francisco

Investigators

• Principal Investigator: Jane A Weintraub, DDS, MPH, University of California, San Francisco (now Univ North Carolina)
• Study Director: Francisco Ramos-Gomez, DDS, MPH, University of California, San Francisco (now Univ Calif Los Angeles)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT00066963
• Other Study ID Numbers: NIDCR-13058
• First Posted: Aug 8, 2003
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by University of California, San Francisco: Early Childhood Caries
• Additional relevant MeSH terms: Dental Caries; Fluorides; Fluorides, Topical

Study Results

Participant Flow

Recruitment Details	January 2001 - July 2002. Supplemental Nutrition Program for Women, Infants & Children (WICs); Womens resource center; medical clinics; pre-schools; dental clinics
Pre-assignment Detail	Cleft lip or palate, developmental or learning disabilities, older than 36 mos; younger than 6 mos,immuno-compromised, born outside SF Bay Area where water is non-fluoridated, lack parental consent; lack 4 maxillary incisors, have caries, other family member in study, transient parents, ineligible to use SF Health Dept service

Arm/Group Title	No Intervention: Counseling Only	Experimental: FV Every 12mo for 24mo + Counsel	Experimental: FV Every 6mo for 24mo + Counsel
Arm/Group Description	Counseling Only (0FV)	Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)	Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
Period Title: Overall Study
STARTED	126	124	126
COMPLETED	100	93	87
NOT COMPLETED	26	31	39

Baseline Characteristics

Arm/Group Title	No Intervention: Counseling Only	Experimental: FV Every 12mo for 24mo + Counsel	Experimental: FV Every 6mo for 24mo + Counsel	Total
Arm/Group Description	Counseling Only (0FV)	Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)	Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)	Total of all reporting groups
Overall Participants	126	124	126	376
Age (Count of Participants)
<=18 years	126 100%	124 100%	126 100%	376 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (Year) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Year]	1.8 (0.6)	1.8 (0.5)	1.8 (0.6)	1.8 (0.6)
Sex: Female, Male (Count of Participants)
Female	68 54%	66 53.2%	64 50.8%	198 52.7%
Male	58 46%	58 46.8%	62 49.2%	178 47.3%
Region of Enrollment (participants) [Number]
United States	126 100%	124 100%	126 100%	376 100%

Outcome Measures

1. Primary Outcome

Title	Number of Caries Incident Cases
Description	A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.
Time Frame	two years

Outcome Measure Data

Analysis Population Description

intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.

Arm/Group Title	Counseling Only	FV 1x/Year + Counseling	FV 2x/Year + Counseling
Arm/Group Description	caregiver counseling only (zero fluoride varnish)	fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling	fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
Measure Participants	100	93	87
Number [participants]	42 33.3%	23 18.5%	14 11.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Counseling Only, FV 1x/Year + Counseling, FV 2x/Year + Counseling
	Comments	Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mantel Haenszel
	Comments	2 d.f.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	3.8
	Confidence Interval	(2-Sided) 95%; 1.9 to 7.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Counseling Only vs FV 2x/yr+Counseling

Adverse Events

Time Frame	3 years
Arm/Group Title	No Intervention: Counseling Only		Experimental: FV Every 12mo for 24mo + Counsel		Experimental: FV Every 6mo for 24mo + Counsel
Arm/Group Description	Counseling Only (0FV)		Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)		Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
All Cause Mortality
	No Intervention: Counseling Only		Experimental: FV Every 12mo for 24mo + Counsel		Experimental: FV Every 6mo for 24mo + Counsel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	No Intervention: Counseling Only		Experimental: FV Every 12mo for 24mo + Counsel		Experimental: FV Every 6mo for 24mo + Counsel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/93 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	No Intervention: Counseling Only		Experimental: FV Every 12mo for 24mo + Counsel		Experimental: FV Every 6mo for 24mo + Counsel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/93 (0%)		1/87 (1.1%)
Skin and subcutaneous tissue disorders
Ulcer on the cheek	0/100 (0%)	0	0/93 (0%)	0	1/87 (1.1%)	1

Limitations/Caveats

In a protocol deviation, children received placebo varnish for 10 months; this would be expected to bias the study toward the null of no difference among groups. The study did not address FV efficacy for children with extant or past caries.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.