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Dentifrice With Innovative Remineralizing Technology (REFIX)

Primary Purpose

Initial Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DENTIFRICE
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Initial Dental Caries focused on measuring caries, white spot lesions, fluoride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • The eligibility criteria were people over 18 years old, without systemic commitment and living in the city of João Pessoa-Paraíba, without water fluoridation (< 0.1 μg/mL F).

Exclusion Criteria:

  • Individuals were excluded if they used drugs that interfere with biofilm formation and salivary flow or fluoride products (> 5000 ppm) in the last 4 weeks, used orthodontic appliances, or had cavity lesions, periodontal disease, and/or tooth sensitivity.

Sites / Locations

  • Federal University of ParaíbaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Sham Comparator

Active Comparator

Experimental

Active Comparator

Arm Label

G0 - placebo

G1: Daily Regenerator Dentalclean Neutro (RDCN)

G2: Sensodyne Repair & Protect (SRP)

G3: Daily Regenerator Dentalclean Acid (RDCA)

G4: Colgate Total Daily Repair (CTDR)

Arm Description

Dental gel without fluoride in the composition

1450 ppm F- of sodium fluoride and tetrasodium pyrophosphate (Refix technology). NEUTRAL pH

1426 ppm of sodium fluoride and calcium sodium phosphosilicate 5% (NOVAMIN technology).

1450 ppm F- of sodium fluoride and tetrasodium pyrophosphate (Refix technology). ACIDIC FORMULA

1450 ppm F- of as sodium fluoride, 0.30% triclosan, arginine, tetrasodium pyrophosphate.

Outcomes

Primary Outcome Measures

FLUORIDE IN SALIVA
Concentration of fluoride in saliva after brushing teeth
FLUORIDE IN DENTAL PLAQUE
Concentration of fluoride in dental biofilm after brushing teeth

Secondary Outcome Measures

Full Information

First Posted
January 26, 2021
Last Updated
February 6, 2023
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT04730908
Brief Title
Dentifrice With Innovative Remineralizing Technology
Acronym
REFIX
Official Title
Dentifrice With Innovative Remineralizing Technology
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 12, 2023 (Anticipated)
Study Completion Date
April 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: The aim of this study is to evaluate in vivo dentifrices containing different active ingredients in fluoride (F) retention in saliva and dental biofilm. Material and methods: The dentifrices used in the study were: G1- Daily Regenerator Dentalclean Neutral (RDCN); G2- Sensodyne Repair & Protect (SRP); G3- Daily Regenerator Dentalclean Acid (RDCA), G4- Colgate Total Daily Repairc (CTDR). A double-blind, randomized crossover clinical study was conducted with eighteen residents of a city without a water fluoridation program. Biofilm and saliva samples were collected 1h and 12h after the last brushing for biofilm and, 1 to 60 minutes and 12 hours for saliva. The concentrations of F in saliva and biofilm were analyzed by specific electrode using the hexamethyldisiloxane facilitated diffusion technique (HMDS). Data were analyzed by repeated measures ANOVA followed by the Bonferroni test (p <0.05). Area under the curve (AUC) was calculated for saliva data. Result: No significant difference was observed between the groups regarding the retention of F in saliva. However, the largest area under the curve values in saliva were found for groups G3 and G4. The highest median values of F-biofilm were found in G3 for 1h and 12h collection times. Conclusion: The toothpaste containing Refix (RDCA) technology presented the most promising results for fluoride retention in oral exposure biomarkers.
Detailed Description
A randomized, duple-blind crossover clinical trial study was performed to evaluate the bioavailability of intraoral fluoride in biomarkers of exposure (biofilm and saliva) after the use of dentifrice with experimental fluoride for one week, with wash-out periods between them. The biofilm was collected 1 hour (h) and 12h after toothbrushing, and saliva was collected 1h (T1, T15, T30, T45, T60 min) and 12h. The data was obtained by potentiometry (ion selective electrode) for fluoride in these samples. Study population The sample size was determined by sample calculation [25], according to previous studies [26], α = 5%, β = 10%, and a dropout ratio of 10%. Eighteen individuals with an average of 26 years old, including both males and females, participated in this study. The eligibility criteria were people over 18 years old, without systemic commitment and living in the city of João Pessoa-Paraíba, without water fluoridation (< 0.1 μg/mL F). Individuals were excluded if they used drugs that interfere with biofilm formation and salivary flow or fluoride products (> 5000 ppm) in the last 4 weeks, used orthodontic appliances, or had cavity lesions, periodontal disease, and/or tooth sensitivity. Experimental Dentifrices The participants were allocated randomly to use the following experimental dentifrices according to table 1. They were coded by an independent investigator not involved in the trial. A simple randomization was performed taking into account a cross design. The unit of randomization was "dentifrice", so all dentifrices had the same chance of being selected. The design of the study was created for each participant and for each new one another draw was made. Clinical Stage First, the participants were submitted to dental prophylaxis and scraping to remove all biofilm and dental calculus. They used a placebo, dentifrice without fluoride, for 7 days. Then, the Whitford protocol was followed [16]. Briefly, the subjects were instructed to brush their teeth three times/day for 1 min (transversal technique) and also to rinse their mouths after brushing with 10 mL of water. On the seventh day, the subjects were instructed to brush only the occlusal surfaces and do not use dental floss, to allow biofilm accumulation. After going to bed, they abstained from eating or drinking anything except water and did not brush their teeth. The next morning, after 12 hours of last brushing, and fasting, the first samples of saliva and biofilm (upper and lower right hemi-arch) were collected. Then, the volunteers brushed the occlusal surfaces for 1 min. Soon after, saliva samples were collected in the following times: t1, t15, t30, t45, and t60 minutes. Biofilme samples (left side) were collected later (1 hour after brushing). Resting saliva was collected for 5 minutes. The biofilm was collected from all tooth surfaces, in both buccal and lingual areas, using a 3S hollenback spatula, from which the samples were immediately transferred to an eppendorff tube, centrifuged and subsequently dried at 90°C for two hours and then weighed. The saliva samples were centrifuged at 6,000 rpm for 10 minutes in order to separate the saliva debris. Determination of the concentration of fluoride The samples were analyzed by the hexamethyldisiloxane (HMDS) facilitated diffusion method of Taves [20] modified by Whitford [21]. The analyzes were performed with a fluoride specific electrode (model 9409; Orion Research) and a potentiometer (model EA 940; Orion Research, Cambridge, MA, USA) (Model 720 A Orion). Fluoride standards (1-100 nM) were used to prepare calibration curves. Statistical analysis The data were analyzed using descriptive and inferential statistics, using the statistical program SPSS - v. 21.0 and software Graphpad. The Shapiro-Wilk test was applied to test the normality of the in vivo study data (n <50). Nonparametric tests were performed. The area under the curve (AUC) was calculated by taking baseline values (12 h after the last brush) up to 60 min after the last brush to indicate the effectiveness of F retention in saliva over time. For the purpose of comparing the concentration of F in saliva and biofilm between the groups, the ANOVA test of repeated measures was performed followed by the Bonferroni post-test. The relationship between the concentrations of biofilm and salivary fluoride was determined using Spearman's correlation coefficient. This study assumed a significance level of 5% (p <0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Initial Dental Caries
Keywords
caries, white spot lesions, fluoride

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover study testing 4 dental gel for brushing teeth. the brushing period of use :7 days, 3 times daily with wahs-out periods of one week.
Masking
ParticipantCare ProviderInvestigator
Masking Description
the products are coded with different color in the label.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G0 - placebo
Arm Type
Placebo Comparator
Arm Description
Dental gel without fluoride in the composition
Arm Title
G1: Daily Regenerator Dentalclean Neutro (RDCN)
Arm Type
Sham Comparator
Arm Description
1450 ppm F- of sodium fluoride and tetrasodium pyrophosphate (Refix technology). NEUTRAL pH
Arm Title
G2: Sensodyne Repair & Protect (SRP)
Arm Type
Active Comparator
Arm Description
1426 ppm of sodium fluoride and calcium sodium phosphosilicate 5% (NOVAMIN technology).
Arm Title
G3: Daily Regenerator Dentalclean Acid (RDCA)
Arm Type
Experimental
Arm Description
1450 ppm F- of sodium fluoride and tetrasodium pyrophosphate (Refix technology). ACIDIC FORMULA
Arm Title
G4: Colgate Total Daily Repair (CTDR)
Arm Type
Active Comparator
Arm Description
1450 ppm F- of as sodium fluoride, 0.30% triclosan, arginine, tetrasodium pyrophosphate.
Intervention Type
Other
Intervention Name(s)
DENTIFRICE
Other Intervention Name(s)
TOOTHPASTE
Intervention Description
GEL -DENTIFRICE FOR BRUSHING TEETH
Primary Outcome Measure Information:
Title
FLUORIDE IN SALIVA
Description
Concentration of fluoride in saliva after brushing teeth
Time Frame
12 hours
Title
FLUORIDE IN DENTAL PLAQUE
Description
Concentration of fluoride in dental biofilm after brushing teeth
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The eligibility criteria were people over 18 years old, without systemic commitment and living in the city of João Pessoa-Paraíba, without water fluoridation (< 0.1 μg/mL F). Exclusion Criteria: Individuals were excluded if they used drugs that interfere with biofilm formation and salivary flow or fluoride products (> 5000 ppm) in the last 4 weeks, used orthodontic appliances, or had cavity lesions, periodontal disease, and/or tooth sensitivity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANDRESSA FEITOSA, PhD
Phone
+558332167795
Email
andressafeitosaboliveira@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
NAYANNA SOARES, Master
Phone
+558332167955
Email
fernandesnayanna58@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FABIO SAMPAIO, PhD
Organizational Affiliation
Universidade Federal da Paraíba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Paraíba
City
João Pessoa
State/Province
Paraíba
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fábio C Sampaio, Doctor
Phone
+55 83 32167795
Email
fcsampa@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Dentifrice With Innovative Remineralizing Technology

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