RBR-4prstkz Effect of the intervention on diet and exercise in the treatment of gingival disease in adult patients who attend the US...

Date of registration: 09/14/2023 ^(mm/dd/yyyy)
Last approval date : 09/14/2023 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1296-8839

• Public title:

  en

  Effect of the intervention on diet and exercise in the treatment of gingival disease in adult patients who attend the USFQ dental clinic for treatment. Quito – Ecuador 2022 – 2024.

  pt-br

  Efeito da intervenção sobre dieta e exercício no tratamento da doença de gengiva em pacientes adultos que frequentam a clínica odontológica da USFQ para tratamento. Quito – Equador 2022 – 2024.

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 2022-061TPG
    Issuing authority: Comitê de Bioética da Universidad San Francisco de Quito

Sponsors

• Primary sponsor: Universidad San Francisco de Quito
• Secondary sponsor:
• Supporting source:
  • Institution: Universidad San Francisco de Quito

Health conditions

• Health conditions:

  en

  Periodontal Diseases

  pt-br

  Doenças Periodontais

• General descriptors for health conditions:

  en

  C07.465 Mouth Diseases

  pt-br

  C07.465 Doença da Boca

• Specific descriptors:

  en

  C07.465.714 Periodontal Diseases

  pt-br

  C07.465.714 Doenças Periodontais

Interventions

• Interventions:

  en

  Patients will be allocated randomly (blocks), using software, to one of four experimental groups (n=23/group): without behavioral intervention, with nutritional guidance, with prescription of physical exercise using an app, and with exercise and diet. All patients will receive complete periodontal treatment (including subgingival instrumentation). Periodontal evaluations will be performed by a blinded and calibrated examiner.

  pt-br

  Os pacientes serão alocados randomizadamente (blocos), utilizando software, a um de quatro grupos experimentais (n=23/grupo): sem intervenção comportamental, com orientação nutricional, com prescrição de exercício físico utilizando aplicativo, e com exercício e dieta. Todos os pacientes receberão tratamento periodontal completo (incluindo instrumentação subgengival). As avaliações periodontais serão realizadas por examinador cego e calibrado.

• Descriptors:

  en

  E06.721.189.675 Periodontal Debridement

  pt-br

  E06.721.189.675 Desbridamento Periodontal

  en

  E02.642.249.270 Diet, Mediterranean

  pt-br

  E02.642.249.270 Dieta Mediterrânea

  en

  G11.427.410.698.277 Exercise

  pt-br

  G11.427.410.698.277 Exercício Físico

Recruitment

• Study status: Recruiting
• Countries
  • Ecuador
• Date first enrollment: 01/01/2023 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  92	-	30 Y	0

• Inclusion criteria:

  en

  Age equal to or greater than 30 years; of both sexes; with more than 15 teeth, at least 30% of which have probing depth (PD) and attachment loss (AL) of at least 4mm and bleeding on probing (SS) or with 6 or more teeth with at least 1 site with PD and AL≥5mm; BMI less than 30.

  pt-br

  Idade igual ou superior a 30 anos; de ambos os sexos; com mais de 15 dentes, sendo que pelo menos 30% dos deles apresentem profundidade de sondagem (PS) e perda de inserção (NIC) de pelo menos 4mm e sangramento à sondagem (SS) ou com 6 ou mais dentes com pelo menos 1 sítio com PS e NIC≥5mm; IMC inferior a 30.

• Exclusion criteria:

  en

  Pregnant or breastfeeding women; Smokers; Patients with other systemic diseases; Scaling and Root Planing performed in the last 12 months; Patients on antibiotic therapy in the last 6 months; Patients on prolonged use of anti-inflammatory drugs; Patients who need antibiotic premedication for dental treatment; Patients who practice regular physical exercise or have been on a diet in the last 6 months.

  pt-br

  Grávidas ou lactantes; Fumantes; Pacientes com outras doenças sistêmicas; Raspagem e Alisamento Radicular realizados nos últimos 12 meses; Pacientes em antibioticoterapia nos últimos 6 meses; Pacientes em uso prolongado de anti-inflamatórios; Pacientes que necessitam de pré-medicação antibiótica para tratamento odontológico; Pacientes que praticam exercícios físicos regulares ou estão em dieta nos últimos 6 meses.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  1	Treatment	Parallel	4	Single-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Number of individuals who reach the treatment endpoint (up to 4 sites with probing depth of 5mm or greater) at day 90.

  pt-br

  Número de indivíduos que atingem o endpoint terapêutico (até 4 bolsas com profundidade de sondagem de 5mm ou mais) aos 90 dias.

• Secondary outcomes:

  en

  Number and percentage of closed pockets (PD up to 4mm with no bleeding) at day 90

  pt-br

  Número e porcentagem de bolsas fechadas (PS até 4mm sem sangramento) aos 90 dias

  en

  Mean full-mouth probing depth at day 90.

  pt-br

  Média de profundidade de sondagem de boca toda aos 90 dias

Contacts

• Public contact
  • Full name: Mauricio Tinajero
  • • Address: Diego de Robles s/n, Quito 170901
    • City: Quito / Ecuador
    • Zip code: 170901
  • Phone: +593998006016
  • Email: fmtinajero@usfq.edu.ec
  • Affiliation: Universidad San Francisco de Quito
   
• Scientific contact
  • Full name: Mauricio Tinajero
  • • Address: Diego de Robles s/n, Quito 170901
    • City: Quito / Ecuador
    • Zip code: 170901
  • Phone: +593998006016
  • Email: fmtinajero@usfq.edu.ec
  • Affiliation: Universidad San Francisco de Quito
   
• Site contact
  • Full name: Mauricio Tinajero
  • • Address: Diego de Robles s/n, Quito 170901
    • City: Quito / Ecuador
    • Zip code: 170901
  • Phone: +593998006016
  • Email: fmtinajero@usfq.edu.ec
  • Affiliation: Universidad San Francisco de Quito
   

Additional links:

• Download in ICTRP format