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Salud Oral Integral: Tratamiento y Rehabilitación Oral en Personas Adultas y Personas Mayores con Edentulismo Parcial o Total

Problema de Salud AUGE N°47

juicio del panel y evidencia

En personas con edentulismo total inferior, el Ministerio de Salud SUGIERE rehabilitar por medio de prótesis fija sobre implante o rehabilitar por medio de sobredentadura implanto asistida (o implantosoportada).
Comentarios del Panel de Expertos:
► La rehabilitación con prótesis fija sobre implante requiere mayor entrenamiento técnico e implica mayor costo.
► En personas con dificultad para realizar una adecuada higiene bucal, la sobredentadura implanto asistida podría ser más adecuada (menor dificultad para realizar la higiene y mantenimiento por parte del cuidador o de la misma persona).

El panel de expertos analizó y debatió cada uno de las preguntas de la “Tabla de la evidencia a la decisión”, considerando tanto la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de los pacientes. Una vez consensuada la postura del panel respecto a las preguntas, emitieron un juicio seleccionando la opción de respuesta que mejor representaba la opinión del conjunto (destacada con color). Finalmente, cuando el panel emitió su juicio sobre todas las preguntas, se emitió la recomendación.

A continuación, se presenta la “Tabla de la evidencia a la decisión” con el resumen de los juicios, la evidencia de investigación evaluada, consideraciones adicionales y comentarios planteados por el panel.

 1.- ¿El problema es una prioridad?
No Probablemente no Probablemente sí Varía No lo sé

El problema ha sido definido como prioritario en el marco de las Garantías Explícitas en Salud (GES), régimen integral de salud que prioriza un grupo de patologías o problemas de salud, garantizando el acceso a tratamiento oportuno y de calidad.

 2.- ¿Qué tan significativos son los efectos deseables anticipados?
Triviales Pequeños Moderados Grandes Varía No lo sé

Pequeños: El panel de expertos de la Guía estimó que los efectos deseables de «rehabilitar por medio de prótesis fija sobre implante» en comparación a «rehabilitar por medio de sobredentadura implanto asistida» son pequeños considerando la evidencia, sin embargo, a experiencia del panel, la evidencia presentada subestima la satisfacción de los pacientes y la calidad de vida respecto a la prótesis fija sobreimplante versus la prótesis implantosoportada. Es relevante considerar que la protesis fija podría producir menos reabsorción.

Evidencia de investigación

Rehabilitar por medio de prótesis fija sobre implante para edentulismo total inferior.

Pacientes

Personas con edentulismo total inferior.

Intervención

Rehabilitar por medio de prótesis fija sobre implante.

Comparación

Rehabilitar por medio de sobredentadura implanto asistida o implantosoportada

Desenlaces

Efecto relativo

(IC 95%)

Estudios/

pacientes

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

Sobredentadura implanto asistida

Prótesis fija sobre implantes

Diferencia

(IC 95%)

Calidad de vida relacionada con la salud oral**

1 ensayo

/ 20 pacientes [9]

89,8

puntos menos

80,2

puntos menos

DM:  

9,6 peor

 (22,97 mejor a 41,17 peor)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría empeorar la calidad de vida en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Nivel de satisfacción del paciente***

1 ensayo

/ 20 pacientes [9]

64,4

puntos

58,3 

puntos

DM: 6,1 menos

(19,25 menos a 7,05 más)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría disminuir el nivel de satisfacción en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Necesidad de rebasado de prótesis antagonista

RR 0,71

(0,41 a 1,22)

 —

2 ensayos

/ 68 pacientes [9,27].

514

por 1000 

365 

por 1000 

Diferencia:

 149 menos

(303 menos a 113 más)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría disminuir la necesidad de rebasado de la prótesis antagonista en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Complicaciones protésicas

2 ensayos

/ 68 pacientes [9,27].

Un estudio [9] reportó 25 eventos de desajuste protésico en el grupo intervención versus 30 eventos en el grupo control a los 12 meses de seguimiento. 

 

En otro estudio [27], en 5 y 17 casos tuvieron que rehacerse las prótesis en el grupo intervención y control respectivamente a los 4 años de seguimiento.

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría tener poco impacto en la incidencia de complicaciones protésicas en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
DM: diferencia de media// RR: Riesgo relativo // IC 95%: Intervalo de confianza del 95%
**La calidad de vida relacionada con la salud oral fue medida el uso de la versión de 49 elementos del Perfil de impacto en la salud oral (OHIP-49). Este cuestionario consta de 49 ítems que cubren siete dominios: limitación funcional, dolor físico, malestar psicológico, discapacidad física, discapacidad psicológica, discapacidad social y discapacidad. Estos ítems son puntuados de 0 a 4, desde nunca (0) a muy a menudo (4).
***Las opiniones de los pacientes sobre sus prótesis actuales en términos de satisfacción general, retención y estabilidad, masticación, higiene bucal, comodidad, habla y estética se evaluaron mediante una escala visual análoga (VAS-14). Cada escala usó una línea de 100 mm con «completa insatisfacción» en un extremo de la línea y «completa satisfacción» en el otro.
1 Se disminuyó un nivel de certeza por riesgo de sesgo, ya que ambos ensayos presentan problemas en la asignación de la secuencia aleatoria y el ocultamiento de esta.
2 Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva a decisiones opuestas, o en los casos en que no se cuenta con un intervalo, se trata de estudios con baja cantidad de pacientes.
Fecha de elaboración de la tabla: Enero, 2019.

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215. Ericsson I, Randow K, Nilner K, Petersson A. Some clinical and radiographical features of submerged and non-submerged titanium implants. A 5-year follow-up study. Clinical oral implants research. 1997;8(5):422-6.
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Búsqueda y Síntesis de Evidencia

 3.- ¿Qué tan significativos son los efectos indeseables anticipados?
Grandes Moderados Pequeños Triviales Varía No lo sé

Pequeños: El panel de expertos de la Guía estimó que los efectos indeseables de «rehabilitar por medio de prótesis fija sobre implante» en comparación a «rehabilitar por medio de sobredentadura implanto asistida» son pequeños, considerando la evidencia y experiencia clínica del panel. La prótesis fija puede implicar mayores dificultades técnicas en su realización, mayor cuidado de higiene y no cubre toda la zona desdentada, produciendo incomodidad, requiere involucrar más tiempo en el cuidado de la higiene y habilidad motriz.

Evidencia de investigación

Rehabilitar por medio de prótesis fija sobre implante para edentulismo total inferior.

Pacientes

Personas con edentulismo total inferior.

Intervención

Rehabilitar por medio de prótesis fija sobre implante.

Comparación

Rehabilitar por medio de sobredentadura implanto asistida o implantosoportada

Desenlaces

Efecto relativo

(IC 95%)

Estudios/

pacientes

Efecto absoluto estimado*

Certeza de la evidencia

(GRADE)

Mensajes clave en términos sencillos

Sobredentadura implanto asistida

Prótesis fija sobre implantes

Diferencia

(IC 95%)

Calidad de vida relacionada con la salud oral**

1 ensayo

/ 20 pacientes [9]

89,8

puntos menos

80,2

puntos menos

DM:  

9,6 peor

 (22,97 mejor a 41,17 peor)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría empeorar la calidad de vida en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Nivel de satisfacción del paciente***

1 ensayo

/ 20 pacientes [9]

64,4

puntos

58,3 

puntos

DM: 6,1 menos

(19,25 menos a 7,05 más)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría disminuir el nivel de satisfacción en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Necesidad de rebasado de prótesis antagonista

RR 0,71

(0,41 a 1,22)

 —

2 ensayos

/ 68 pacientes [9,27].

514

por 1000 

365 

por 1000 

Diferencia:

 149 menos

(303 menos a 113 más)

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría disminuir la necesidad de rebasado de la prótesis antagonista en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

Complicaciones protésicas

2 ensayos

/ 68 pacientes [9,27].

Un estudio [9] reportó 25 eventos de desajuste protésico en el grupo intervención versus 30 eventos en el grupo control a los 12 meses de seguimiento. 

 

En otro estudio [27], en 5 y 17 casos tuvieron que rehacerse las prótesis en el grupo intervención y control respectivamente a los 4 años de seguimiento.

⊕◯◯◯1,2

Muy baja

Rehabilitar con prótesis fija sobre implante podría tener poco impacto en la incidencia de complicaciones protésicas en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja.

GRADE: Grados de evidencia Grading of Recommendations Assessment, Development and Evaluation.
DM: diferencia de media// RR: Riesgo relativo // IC 95%: Intervalo de confianza del 95%
**La calidad de vida relacionada con la salud oral fue medida el uso de la versión de 49 elementos del Perfil de impacto en la salud oral (OHIP-49). Este cuestionario consta de 49 ítems que cubren siete dominios: limitación funcional, dolor físico, malestar psicológico, discapacidad física, discapacidad psicológica, discapacidad social y discapacidad. Estos ítems son puntuados de 0 a 4, desde nunca (0) a muy a menudo (4).
***Las opiniones de los pacientes sobre sus prótesis actuales en términos de satisfacción general, retención y estabilidad, masticación, higiene bucal, comodidad, habla y estética se evaluaron mediante una escala visual análoga (VAS-14). Cada escala usó una línea de 100 mm con «completa insatisfacción» en un extremo de la línea y «completa satisfacción» en el otro.
1 Se disminuyó un nivel de certeza por riesgo de sesgo, ya que ambos ensayos presentan problemas en la asignación de la secuencia aleatoria y el ocultamiento de esta.
2 Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva a decisiones opuestas, o en los casos en que no se cuenta con un intervalo, se trata de estudios con baja cantidad de pacientes.
Fecha de elaboración de la tabla: Enero, 2019.

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212. Heydecke G, McFarland DH, Feine JS, Lund JP. Speech with maxillary implant prostheses: ratings of articulation. Journal of dental research. 2004;83(3):236-40.
213. de Grandmont P, Feine JS, Taché R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. Journal of dental research. 1994;73(5):1096-104.
214. Raghoebar, Gerry M., Meijer, Henny J. A., Stegenga, Boudewijn, Van’t Hof, Martin A., Van Oort, Rob P., Vissink, Arjan. Effectiveness of three treatment modalities for the edentulous mandible. Clinical Oral Implants Research. 2000;11(3):195-201.
215. Ericsson I, Randow K, Nilner K, Petersson A. Some clinical and radiographical features of submerged and non-submerged titanium implants. A 5-year follow-up study. Clinical oral implants research. 1997;8(5):422-6.
216. Weber HP, Crohin CC, Fiorellini JP. A 5-year prospective clinical and radiographic study of non-submerged dental implants. Clinical oral implants research. 2000;11(2):144-53.

Búsqueda y Síntesis de Evidencia

 4.- ¿Cuál es la certeza general de la evidencia sobre efectos?
Muy baja Baja Moderada Alta Ningún estudio incluido

Muy Baja: Existe considerable incertidumbre respecto del efecto de «rehabilitar por medio de prótesis fija sobre implante» en comparación a «rehabilitar por medio de sobredentadura implanto asistida». La certeza general de la evidencia se establece en función del desenlace o resultado en salud considerado como crítico para los pacientes, en este caso, calidad de vida.

Evidencia de investigación

Desenlaces

Importancia

Certeza de la evidencia

(GRADE)

Calidad de vida relacionada con la salud oral

CRÍTICO

⨁◯◯◯

MUY BAJAa,b

Satisfacción del paciente

IMPORTANTE

⨁◯◯◯

MUY BAJAa,b

Necesidad de rebasado de prótesis maxilar

NO ES IMPORTANTE 

⨁◯◯◯

MUY BAJAa,b

Complicaciones protésicas

IMPORTANTE

⨁◯◯◯

MUY BAJAa,b

a. Se disminuyó un nivel de certeza por riesgo de sesgo, ya que ambos ensayos presentan problemas en la asignación de la secuencia aleatoria y el ocultamiento de esta.
b. Se disminuyó dos niveles de certeza de evidencia por imprecisión, ya que cada extremo del intervalo de confianza conlleva a decisiones opuestas, o en los casos en que no se cuenta con un intervalo, se trata de estudios con baja cantidad de pacientes.

 5.- ¿Hay incertidumbre importante o variabilidad sobre qué tanto valora la gente los desenlaces principales?
Incertidumbre o variabilidad importantes Posiblemente hay incertidumbre o variabilidad importantes Probablemente no hay incertidumbre ni variabilidad importantes No hay variabilidad o incertidumbre importante

Probablemente no hay incertidumbre ni variabilidad importantes: En función de la evidencia de investigación, experiencia clínica, conocimiento de gestión o experiencia de las personas con la condición o problema de salud, el panel de expertos de la Guía consideró que probablemente no hay incertidumbre o variabilidad importante respecto a lo que escogería una persona informada de los efectos deseables e indeseables de «rehabilitar por medio de prótesis fija sobre implante» y «rehabilitar por medio de sobredentadura implanto asistida». A pesar de la evidencia presentada, el panel considera que en Chile la mayoría de las personas escogerían la prótesis fija. Dentro de las personas que no escogerían esta alternativa, pordrían estar cuidadores de pacientes con dependencia moderada a severa, lo cuales podrían optar por la protesis implanto retenida dado que se ajusta mejor a las características/necesidades del paciente, ya que los cuidados de la higiene están a cargo de un cuidador.

Evidencia de investigación

Un estudio (1) evaluó la satisfacción de los pacientes con edentulismo total inferior respecto rehabilitar con prótesis fija en comparación con sobredentadura implanto asistida (o implantosoportada), de este se concluye que con prótesis fija sobre implante podría disminuir el nivel de satisfacción en comparación a rehabilitar con prótesis implantoasistida. Sin embargo, existe considerable incertidumbre dado que la certeza de la evidencia es muy baja. Las opiniones de los pacientes sobre sus prótesis se midieron en función de su satisfacción general, retención y estabilidad, masticación, higiene bucal, comodidad, habla y estética, se utilizó la escala visual análoga (VAS-14). Cada escala usó una línea de 100 mm con «completa insatisfacción» en un extremo de la línea y «completa satisfacción» en el otro, el grupo con sobredentadura implanto asistida obtuvo una media de 64,4 puntos, mientras que aquellos con prótesis fila tuvieron una media de 58,3 puntos.
En una búsqueda complementaria y específica de valores y preferencias de los pacientes, no se encontraron estudios relevantes.

Referencias

1. De Kok IJ, Chang K-H, Lu T-S, Cooper LF. Comparison of three-implant-supported fixed dentures and two-implant-retained overdentures in the edentulous mandible: a pilot study of treatment efficacy and patient satisfaction. Int J Oral Maxillofac Implants [Internet]. [cited 2019 Dec 19];26(2):415–26. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21483895

Búsqueda y Síntesis de Evidencia

 6.- El balance entre efectos deseables e indeseables favorece la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía No lo sé

No favorece la intervención ni la comparación: Considerando que la intervención es «rehabilitar por medio de prótesis fija sobre implante» y la comparación es «rehabilitar por medio de sobredentadura implanto asistida», el panel de expertos de la Guía opinó que el balance entre efectos deseables e indeseables no favorece ninguna de las dos alternativas. Esto considerando de que existe certeza muy baja de la evidencia, que los efectos deseables e indeseables de la prótesis fija respecto a la sobredentadura implanto asistida son pequeños. A pesar de que el panel estima que la mayoría de los pacientes preferiría una prótesis fija, indica que en pacientes con dependencia moderada a severa la protesis implanto retenida podría ajustarse mejor a las características/necesidades del paciente, ya que los cuidados de la higiene están a cargo de un cuidador.

 7.- ¿Qué tan grandes son los recursos necesarios (costos)?
Costos extensos Costos moderados Costos y ahorros despreciables Ahorros moderados Ahorros extensos Varía No lo sé

Costos extensos: El panel de expertos de la Guía consideró que los costos de «rehabilitar por medio de prótesis fija sobre implante» son grandes si se compara con los costos de «rehabilitar por medio de sobredentadura implanto asistida», en función de los antecedentes, experiencia clínica, conocimiento de gestión o experiencia de los pacientes.

Evidencia de investigación

A continuación, se muestran los costos referenciales, es preciso considerar que estos costos fueron recogidos con el único objetivo de constituir un antecedente aproximado.

Desenlaces

Importancia

Certeza de la evidencia

(GRADE)

Calidad de vida relacionada con la salud oral

CRÍTICO

⨁◯◯◯

MUY BAJAa,b

Satisfacción del paciente

IMPORTANTE

⨁◯◯◯

MUY BAJAa,b

Necesidad de rebasado de prótesis maxilar

NO ES IMPORTANTE 

⨁◯◯◯

MUY BAJAa,b

Complicaciones protésicas

IMPORTANTE

⨁◯◯◯

MUY BAJAa,b

** Esta ítem está compuesto por varias prestaciones sanitarias.
** El programa de prestaciones valoradas son paquetes de servicios o productos de salud entregados por hospitales públicos, los cuales son costeadas por FONASA contra producción. Solo algunos hospitales públicos adhieren a estos paquetes y su valor es un estimado estándar.
Referencias:
1. Precio obtenido de la base de datos del Programa de Prestaciones Valoradas. Este precio agrupa varias prestaciones.
2. Precio indicado por Clínica Privada (Integramédica, 2018).

Referencias

1. Precio obtenido de la base de datos del Programa de Prestaciones Valoradas. Este precio agrupa varias prestaciones.
2. Precio indicado por Clínica Privada (Integramédica, 2018).

Búsqueda y Síntesis de Evidencia

 8.- ¿La costo-efectividad de la intervención beneficia la intervención o la comparación?
Favorece la comparación Probablemente favorece la comparación No favorece la intervención ni la comparación Probablemente favorece la intervención Favorece la intervención Varía Ningún estudio incluido

Probablemente favorece la intervención: Considerando que la intervención es «rehabilitar por medio de prótesis fija sobre implante» y la comparación es «rehabilitar por medio de sobredentadura implanto asistida», el panel de expertos de la Guía opinó que probablemente la alternativa más costo-efectiva es «rehabilitar por medio de prótesis fija sobre implante». A pesar de existir evidencia respecto a la costo efectividad de la prótesis fija, esta cálculo proviene de otros contextos, lo que podría no ser del todo transferible a Chile.

Evidencia de investigación

Se hizo una revisión de evidencia y se encontraron algunos estudios que pudieran responder la pregunta, sin embargo, el panel desestimó la evidencia, indicando que son estudios que no son aplicable al contexto nacional dado que en Chile el precio de la intervención representa una proporción mayor respecto a los ingresos promedios de la población. Ver Informe de búsqueda y síntesis de evidencia de
costo-efectividad de las intervenciones.

Referencias

1. Zitzmann NU, Marinello CP, Sendi P. A cost-effectiveness analysis of implant overdentures. J Dent Res. 2006;85(8):717–21.
2. Heydecke G, Penrod JR, Takanashi Y, Lund JP, Feine JS, Thomason JM. Cost-effectiveness of Mandibular and Conventional Dentures and Conventional Dentures in the Edentulous Elderly. J Dent Res. 2005;84(9):794–9.

Búsqueda y Síntesis de Evidencia

 9.- ¿Cuál sería el impacto en equidad en salud?
Reducido Probablemente reducido Probablemente ningún impacto Probablemente aumentado Aumentado Varía No lo sé

Reducida: El panel de expertos de la Guía consideró que la equidad en salud se reduciría si se recomendase «rehabilitar por medio de prótesis fija sobre implante», dado que no hay oferta en el sistema público, las personas con menores recursos tendrían mayores barreras para acceder a las prótesis fija.

 10.- ¿La intervención es aceptable para las partes interesadas?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente no: El panel de expertos de la Guía consideró que «rehabilitar por medio de prótesis fija sobre implante» probablemente NO es aceptable por algunas de las partes interesadas, dados los costos y la complejidad técnica.

 11.- ¿Es factible implementar la intervención?
No Probablemente no Probablemente sí Varía No lo sé

Probablemente no: El panel de expertos de la Guía consideró que «rehabilitar por medio de prótesis fija sobre implante» probablemente NO es factible implementar, contemplando que debe existir entrenamiento del profesional y equipamiento que no está implementado actualmente en el país.