RBR-5dxg2k Wear control caused by diet or illness in patients with reflux- clinical study

Date of registration: 04/07/2020 ^(mm/dd/yyyy)
Last approval date : 04/07/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1248-3663

• Public title:

  en

  Wear control caused by diet or illness in patients with reflux- clinical study

  pt-br

  Controle do desgaste provocado por ácidos da dieta ou do organismo em pacientes com refluxo- um estudo clínico

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 27175219.0.0000.5327
    Issuing authority: Plataforma Brasil
  • 3.824.425
    Issuing authority: Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre

Sponsors

• Primary sponsor: Hospital de Clínicas de Porto Alegre
• Secondary sponsor:
  • Institution: Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
• Supporting source:
  • Institution: Próprio
  • Institution: Hospital de Clínicas de Porto Alegre

Health conditions

• Health conditions:

  en

  Erosive tooth wear; Gastroesophageal Reflux

  pt-br

  Desgaste dentário erosivo; Refluxo Gastroesofágico

• General descriptors for health conditions:

  en

  K00-K93 XI - Diseases of the digestive system

  pt-br

  K00-K93 XI - Doenças do aparelho digestivo

• Specific descriptors:

Interventions

• Interventions:

  en

  Toothpaste with stannous fluoride Toothpaste with tin fluoride 1) Test Group 1 (n = 60): Dentifrice with tin (0.454% SnF2) and soft brush to perform home oral hygiene twice a day. 2) Test Group 2 (n = 60): Tin toothpaste (0.454% SnF2) and soft brush to perform home oral hygiene twice a day associated with the use of intraoral plaque during the night. 3) Control Group (n = 60): Conventional toothpaste (1100 ppm NaF) and soft brush to perform home oral hygiene twice a day.

  pt-br

  Dentifrício com fluoreto de estanho 1) Grupo Teste 1 (n=60): Dentifrício com estanho (0,454% de SnF2) e escova macia para realização da higiene bucal domiciliar 2x/dia. 2) Grupo Teste 2 (n=60): Dentifrício com estanho (0,454% de SnF2) e escova macia para realização da higiene bucal domiciliar 2x/dia associado ao uso de placa intraoral durante a noite. 3) Grupo Controle (n=60): Dentifrício convencional (1100 ppm de NaF) e escova macia para realização da higiene bucal domiciliar 2x/dia.

• Descriptors:

  en

  D25.376 Dentifrices

  pt-br

  D25.376 Dentifrícios

  es

  D25.376 Dentífricos

  en

  VS2.003.002.005 Oral and Dental Hygiene Products

  pt-br

  VS2.003.002.005 Produtos para Higiene Dental e Bucal

  es

  VS2.003.002.005 Productos para la Higiene Dental y Bucal

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 03/31/2020 ^(mm/dd/yyyy)
• Date last enrollment: 03/31/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  180	-	18 -	90 -

• Inclusion criteria:

  en

  Individuals aged >= 18 years; both sexes; diagnosis of positive gatroesophageal reflux disease; at least one tooth with erosive tooth wear

  pt-br

  Indivíduos com idade >= 18 anos; ambos os sexos; diagnóstico de doença do refluxo gatroesofágico positivo; pelo menos um dente com desgaste dentário erosivo

• Exclusion criteria:

  en

  Individuals with special needs; <18 years; with difficulties in understanding the protocol and its guidelines

  pt-br

  Indivíduos com necessidades especiais; < 18 anos ; com dificuldades de entendimento do protocolo e suas orientações

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	3	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Progression of erosive tooth wear; considered an increase in the score of the Basic Erosive Wear Examination (BEWE) index; determined every 6 months

  pt-br

  Progressão do desgaste dentário erosivo; considerado um aumento no escore do Índice Basic Erosive Wear Examination (BEWE); determinada a cada 6 meses

• Secondary outcomes:

  en

  Change in reflux symptoms; verified through a questionnaire; dichotomous variable (improvement in symptoms: yes or no); assessed every 6 months

  pt-br

  Alteração nos sintomas do refluxo; verificado através de questionário; variável dicotômica (melhora nos sintomas: sim ou não); avaliada a cada 6 meses

Contacts

• Public contact
  • Full name: Débora Nunes de Oliveira Racki
  • • Address: R. Ramiro Barcelos, 2492 - Santana, Porto Alegre - RS, 90035-003
    • City: Porto Alegre / Brazil
    • Zip code: 90035-003
  • Phone: 55 (51) 985723100
  • Email: deboranunes.oliveira@hotmail.com
  • Affiliation: Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
   
• Scientific contact
  • Full name: Débora Nunes de Oliveira Racki
  • • Address: R. Ramiro Barcelos, 2492 - Santana, Porto Alegre - RS, 90035-003
    • City: Porto Alegre / Brazil
    • Zip code: 90035-003
  • Phone: 55 (51) 985723100
  • Email: deboranunes.oliveira@hotmail.com
  • Affiliation: Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
   
• Site contact
  • Full name: Débora Nunes de Oliveira Racki
  • • Address: R. Ramiro Barcelos, 2492 - Santana, Porto Alegre - RS, 90035-003
    • City: Porto Alegre / Brazil
    • Zip code: 90035-003
  • Phone: 55 (51) 985723100
  • Email: deboranunes.oliveira@hotmail.com
  • Affiliation: Faculdade de Odontologia da Universidade Federal do Rio Grande do Sul
   

Additional links:

• Download in ICTRP format