Evaluation in Vivo of Mouthwash With Nanoencapsulated Fluoride

Dental Caries Clinical Trial

Official title:

Evaluation in Vivo of Experimental Mouthwash With Nanoencapsulated Fluoride

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143086
• Other study ID #: NanoFMouthwash
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2016
• Est. completion date: December 20, 2017

Study information

• Verified date: November 2021
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The literature recognizes that fluoride is the most widely used and studied means for dental remineralization. The use of fluoride mouthwashes is shown as an effective way to increase the fluoride intraoral availability. However, the current challenge is the substantivity, so new compounds have been introduced into these formulations. This study aims to evaluate the in vivo effect of fluoride mouthwash containing nanoencapsulated Fluoride (NanoF) - in fluoride retention in saliva and dental plaque. A study of the clinical and laboratory type, crossover, double-blind, randomized will be held. After sample calculation, the total of 12 individuals aged between 18 and 35 years old, healthy, decayed, missing, and filled teeth index less than 6 and residents in brazilian northeast capital will be part of the sample. Fluoride bioavailability will be evaluated in the biofilm and saliva after the use of fluoridated weekly. The biofilm will be assessed on 1h and 12 h after rinsing; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. It will be 3 mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride and Free sodium fluoride. Between weeks of use, rinsing will be extended washout (without fluoride) to avoid carryover effect. Inferential data analysis will be carried out, considering the amount of alpha <0.05. So knowing that caries is a dynamic process, the largest fluoride retention in the oral fluids promoted by the Nanoencapsulated Fluoride may have important impact on Des-Re process and in the control of dental caries.

Description:

1. Study design It is a quantitative study of double-blind randomized crossover clinical type with inductive approach and documentation of technical and direct observation with measurements in the laboratory.

In order to assess the bioavailability of intraoral fluoride week after the use of fluoride mouthwashes containing Nanoencapsulated Fluoride, it will be collected biofilm samples 1h and 12 h after rinse; and unstimulated saliva in times of 3, 15, 30, 45, 60 minutes and 12 hours after. The data will be obtained by physical and chemical analysis of the samples of fluoride (F). Therefore, the study will consist of two interrelated steps: a clinical phase for biofilm collection and saliva; and laboratory stage for fluoride analysis in the samples.

Will be conducted pilot test with three participants before the start of the study.

2. Sample Size The sample size calculation was performed using fluoride concentration data in dental biofilm previous study and taking effect size difference between the experimental mouthwash (100% Nanoencapsulated Fluoride ) and positive control of at least 3.4 ppm of F- in biofilm after 12 hours, namely, 25%. Admitting experimental protocol with beta error of 10% alpha error of 5%, one-tailed and statistical power of 90%, the sample size was calculated for 6 people. For the calculation we used the Excel software and mathematical formula for clinical trials of superiority given. Adding sample loss resulted in 12 people.

3. Experimental Mouthwash For this study will be used four mouthwashes: 50% Nanoencapsulated Fluoride, 100% Nanoencapsulated Fluoride, Free sodium fluoride, Without fluoride. The mouthwash, made available by the company from Brazil are packed in the same packaging and have the taste of mint. Except wash out the packing with mouthwash will be identified by letters (A, B and C) by an independent researcher. The letters code will not be revealed to the participants nor the researcher who will accompany them. These will be drawn at random for daily use for seven days in four times, giving an interval of one week wash-out between them.

In these periods of wash-out will use a mouthwash without fluoride. In the end, all study participants will use the 5 experimental mouthwash at different times. A dentifrice without fluoride will be used by the participant during the study.

4. Clinical phase The participant will be informed about the study and after its acceptance, he/she will initiate the study. Initially will be clinical examination in order to report the presence of any of the exclusion criteria already listed. After verifying the absence of these criteria, there will be a dental prophylaxis pumice for removal of this biofilm and in some cases may be made supragingival scraping. The patient will be advised not to make use of any fluoride product during the experiment. At first, volunteers are instructed to use a mouthwash without fluoride (wash out) the first week, in order to equate the study participants and eliminate any potential carryover effects of toothpaste or mouthwash used previously.

The participant will get a packing of mouthwash and will be instructed to brush their teeth for 1 minute with the dentifrice without fluoride and rinse with 10 mL of mouthwash for 1 min twice a day (morning and night). On the seventh day, the participant will be instructed to brush only the occlusal surfaces of your teeth, to allow biofilm accumulation of flat surfaces, and rinse with the mouthwash. When going to bed, you are warned not to eat or drink (except water) as well as not brushing your teeth until the next day. On the following morning, approximately 12 hours after the last brushing and fasting, the first dental biofilm sample and unstimulated saliva is collected. It will be used to remove biofilm Hollenback vestibular faces, interproximal, palatal and lingual right hemiarch and deposited in a pre-weighed Eppendorf tube in an analytical balance. To saliva collection, the participant, at rest, will be instructed to spit for a minute in a graduated glass tube. After that, the participant will brush the occlusal surfaces for 1 min and rinse with 10 mL of the mouthwash for 1 min. Soon after, will new collection of saliva and plaque. Saliva samples will give up in times of 3, 15, 30, 45 and 60 minutes after brushing, while the biofilm left hemiarch will be collected one hour after brushing. After the collection will be offered at breakfast organized by researchers participating in the crown of that research center.

5. Laboratorial phase Samples will be evaluated through physical-chemical analysis of fluoride using calibrated fluoride electrode. Samples will be analyzed for fluoride concentration using ion-specific electrode after diffusion facilitated with hexamethyl disiloxane (HMDS). The calibration curve is made for each analysis. All analyzes will be done in triplicate and be submitted for validation.

6. Data analysis The study data will be analyzed by inferential statistics considering p <0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 20, 2017
• Est. primary completion date: November 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 32 Years

Eligibility

Inclusion Criteria:

• resident in João Pessoa;

• Decayed, Missing, Filled Index<6;

• Healthy

Exclusion Criteria:

• orthodontic treatment;

• gingivitis;

• Periodontal disease;

• Smokers;

• Present active tooth decay;

• Tooth sensitivity;

• Those undergoing treatment with fluoride products and / or use of antimicrobials in the past four weeks

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Mouthwash 100% Nano-F
Use 10 ml of mouthwash 100% Nanoencapsulated Fluoride after brushing for one week, twice a day.
• Mouthwash 50% Nano-F
Use 10 ml of mouthwash 50% Nanoencapsulated Fluoride after brushing for one week, twice a day.
• Mouthwash standard
Use 10 ml of mothwash after brushing for one week, twice a day. It's for the positive control of fluoride.
• Placebo
Use 10 ml of mouthwash without fluoride

Locations

Country	Name	City	State
Brazil	Federal University of Paraíba	João Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Fabio Correia Sampaio

Country where clinical trial is conducted

Brazil, 

References & Publications (7)

Buzalaf MA, Vilhena FV, Iano FG, Grizzo L, Pessan JP, Sampaio FC, Oliveira RC. The effect of different fluoride concentrations and pH of dentifrices on plaque and nail fluoride levels in young children. Caries Res. 2009;43(2):142-6. doi: 10.1159/000211717 — View Citation

Duckworth RM, Jones S. On the relationship between the rate of salivary flow and salivary fluoride clearance. Caries Res. 2015;49(2):141-6. doi: 10.1159/000365949. Epub 2015 Jan 27. — View Citation

Duckworth RM, Morgan SN, Gilbert RJ. Oral fluoride measurements for estimation of the anti-caries efficacy of fluoride treatments. J Dent Res. 1992 Apr;71 Spec No:836-40. Review. — View Citation

Pessan JP, Conceição JM, Grizzo LT, Székely M, Fazakas Z, Buzalaf MA. Intraoral fluoride levels after use of conventional and high-fluoride dentifrices. Clin Oral Investig. 2015 May;19(4):955-8. doi: 10.1007/s00784-015-1426-3. Epub 2015 Feb 14. — View Citation

Pessan JP, Pinto Alves KM, Italiani Fde M, Ramires I, Lauris JR, Whitford GM, Toumba KJ, Robinson C, Buzalaf MA. Distribution of fluoride and calcium in plaque biofilms after the use of conventional and low-fluoride dentifrices. Int J Paediatr Dent. 2014 — View Citation

Pessan JP, Silva SM, Lauris JR, Sampaio FC, Whitford GM, Buzalaf MA. Fluoride uptake by plaque from water and from dentifrice. J Dent Res. 2008 May;87(5):461-5. — View Citation

Whitford GM, Wasdin JL, Schafer TE, Adair SM. Plaque fluoride concentrations are dependent on plaque calcium concentrations. Caries Res. 2002 Jul-Aug;36(4):256-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability of intraoral fluoride (biofilm and saliva) collection of dental plaque(biofilm) and saliva		six months