RBR-56nzq6 Root coverage of multiple gingival recessions treated with a coronary repositioned flap associated with connective…

Date of registration: 08/06/2020 ^(mm/dd/yyyy)
Last approval date : 08/06/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1246-3534

• Public title:

  en

  Root coverage of multiple gingival recessions treated with a coronary repositioned flap associated with connective tissue graft or collagen matrix graft of porcine origin.

  pt-br

  Recobrimento de retração gengival múltipla tratada com retalho reposicionado coronariamente associada a enxerto de tecido conjuntivo ou enxerto de matrix colágena de origem suína.

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 10693719.4.0000.5374
    Issuing authority: Plataforma Brasil
  • 3.575.552
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade São Leopoldo Mandic

Sponsors

• Primary sponsor: Faculdade São Leopoldo Mandic
• Secondary sponsor:
  • Institution: Faculdade São Leopoldo Mandic
• Supporting source:
  • Institution: Faculdade São Leopoldo Mandic

Health conditions

• Health conditions:

  en

  Gingival recession

  pt-br

  Retração gengival

• General descriptors for health conditions:

  en

  C07 Stomatognathic diseases

  pt-br

  C07 Doenças estomatognáticas

  es

  C07 Enfermedades estomatognáticas

• Specific descriptors:

Interventions

• Interventions:

  en

  15 patients with bilateral multiple Miller class I and II recessions will be treated root coverage surgery with coronal flap positioning. Each patient will receive both interventions. On one side, the flap will be associated with a collagen xenogenic matrix (test group) while the other will be associated with connective tissue graft (control group). Suture will be removed at 14 days. Patients will be reassessed at 30, 90 and 120 days.

  pt-br

  15 pacientes que possuam recessões múltiplas classe I e II de Miller bilaterais serão submetidos a cirurgia de recobrimento radicular com posicionamento coronal do retalho. Cada paciente receberá ambas as intervenções. Em um dos lados o retalho será associado a matriz colágena xenógena (grupo teste) enquanto o outro será associado a enxerto de tecido conjuntivo(grupo controle). Sutura será removida aos 14 dias. Os pacientes serão reavaliados aos 30, 90 e 120 dias.

• Descriptors:

  en

  H02.403.810.788 Surgery, Plastic

  pt-br

  H02.403.810.788 Cirurgia Plástica

  es

  H02.403.810.788 Cirugía Plástica

  en

  D05.750.078.280.300.100 Collagen Type I

  pt-br

  D05.750.078.280.300.100 Colágeno Tipo I

  es

  D05.750.078.280.300.100 Colágeno Tipo I

  en

  E02.095.147.725 Tissue Transplantation

  pt-br

  E02.095.147.725 Transplante de Tecidos

  es

  E02.095.147.725 Trasplante de Tejidos

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 02/01/2020 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  15	-	18 Y	60 Y

• Inclusion criteria:

  en

  Patients aged between 18 and 60 years; both sexes; bilateral multiple Miller class I and II recessions associated or not with non-carious cervical lesions.

  pt-br

  Pacientes com idade entre 18 e 60 anos; de ambos os sexos; recessões múltiplas classe I e II de Miller bilaterais associadas ou não à lesões cervicais não cariosas.

• Exclusion criteria:

  en

  Smokers; Alterations in the systemic health; Active periodontal disease; Interproximal bone loss

  pt-br

  Fumantes; Alterações sistêmicas; Presença de doença periodontal; perda óssea interproximal

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Other	2	Double-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Percentage of root coverage, verified by the difference between the initial and final (after 180 days of surgical therapy) gingival recession (measured with a millimeter-gauged probe) divided by the initial recession.

  pt-br

  Porcentagem de Recobrimento radicular, verificado pela diferença entre a recessão gengival (medida com sonda periodontal milimetrada) inicial e final (após 180 dias da terapia cirurgica), dividida pela recessão inicial.

• Secondary outcomes:

  en

  The percentage of complete root coverage, measuring the distance from the gingival margin to the cement-enamel junction with a millimeter probe at 180 days.

  pt-br

  Presença de recobrimento radicular completo, verificado com sonda milimetrada a distância da margem gengival à junção cemento-esmalte, aos 180 dias.

  en

  The gain of keratinized tissue, evaluated by comparing the keratinized tissue height measured with a millimeter probe at 180 days with the initial measurements.

  pt-br

  Ganho de tecido queratinizado, comparando a altura de faixa de tecido queratinizado, medida com sonda milimetrada, aos 180 dias com as medidas iniciais.

Contacts

• Public contact
  • Full name: Julio Cesar Joly
  • • Address: R. Dr. José Rocha Junqueira, 13 - Pte. Preta
    • City: Campinas / Brazil
    • Zip code: 13045-755
  • Phone: +55 19 981149515
  • Email: joly@implanteperio.com.br
  • Affiliation: Faculdade São Leopoldo Mandic
   
• Scientific contact
  • Full name: Julio Cesar Joly
  • • Address: R. Dr. José Rocha Junqueira, 13 - Pte. Preta
    • City: Campinas / Brazil
    • Zip code: 13045-755
  • Phone: +55 19 981149515
  • Email: joly@implanteperio.com.br
  • Affiliation: Faculdade São Leopoldo Mandic
   
• Site contact
  • Full name: Julio Cesar Joly
  • • Address: R. Dr. José Rocha Junqueira, 13 - Pte. Preta
    • City: Campinas / Brazil
    • Zip code: 13045-755
  • Phone: +55 19 981149515
  • Email: joly@implanteperio.com.br
  • Affiliation: Faculdade São Leopoldo Mandic
   

Additional links:

• Download in ICTRP format