Dentifrice With Innovative Remineralizing Technology

NCT04730908 | Unknown DMC

• 1 other identifier: REFIX-UFPB
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Initial Dental Caries

Keywords

caries, white spot lesions, fluoride

Outcome Measures

Primary Outcomes (2)

• FLUORIDE IN SALIVA

  Concentration of fluoride in saliva after brushing teeth

  12 hours

• FLUORIDE IN DENTAL PLAQUE

  Concentration of fluoride in dental biofilm after brushing teeth

  12 hours

Study Arms (5)

G0 - placebo

PLACEBO COMPARATOR

Dental gel without fluoride in the composition

Other: DENTIFRICE

G1: Daily Regenerator Dentalclean Neutro (RDCN)

SHAM COMPARATOR

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

Other: DENTIFRICE

G2: Sensodyne Repair & Protect (SRP)

ACTIVE COMPARATOR

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

Other: DENTIFRICE

G3: Daily Regenerator Dentalclean Acid (RDCA)

EXPERIMENTAL

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

Other: DENTIFRICE

G4: Colgate Total Daily Repair (CTDR)

ACTIVE COMPARATOR

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

Other: DENTIFRICE

Interventions

DENTIFRICE OTHER

GEL -DENTIFRICE FOR BRUSHING TEETH

Also known as: TOOTHPASTE

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Federal University of Paraíba

João Pessoa, Paraíba, Brazil

RECRUITING

MeSH Terms

Interventions

Dentifrices; Toothpastes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Cosmetics; Specialty Uses of Chemicals; Chemical Actions and Uses; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• FABIO SAMPAIO, PhD

  Universidade Federal da Paraíba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ANDRESSA FEITOSA, PhD

CONTACT

+558332167795; andressafeitosaboliveira@gmail.com

NAYANNA SOARES, Master

CONTACT

+558332167955; fernandesnayanna58@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: the products are coded with different color in the label.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: January 29, 2021
• Study Start: February 3, 2020
• Primary Completion: February 12, 2023
• Study Completion: April 12, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)