Ensayos Clínicos

Actividad científica en humanos dirigida hacia el

entendimiento de las características clínicas de la
enfermedad y hacia la evaluación de
intervenciones terapéuticas y diagnósticas.

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Ensayo Clínico

Evaluación experimental para comparar un

producto, substancia, medicamento,
dispositivo, régimen o procedimiento
Investigación Clínica Ensayos Clínicos con otro

vs

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¿Cuándo se realiza un ensayo clínico?

Después de que investigadores prueban

nuevos tratamientos en el laboratorio y en
animales, los tratamientos con los resultados
mas prometedores son llevados a
ensayos clínicos.
Pregunta de investigación
Otras líneas de evidencia “madura”

Ensayo clínico
(fase final y decisiva de numerosas 1
líneas de investigación)

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 ¿Porqué se realizan ensayos clínicos?
Muchos nuevos tratamientos y medicamentos
prueban ser seguros y eficaces en tubos de
ensayo y en animales, pero deben probar ser
seguros y efectivos en humanos antes de que se
puedan prescribir.
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Tratamiento
Evalúan tratamientos experimentales, nuevos
medicamentos o combinaciones de
medicamentos, nuevas intervenciones
quirúrgicas o procedimientos.
Propósito
Curar, rehabilitar, aliviar o prolongar la vida
Control de una enfermedad o condición
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Diagnóstico
Se evalúan nuevas pruebas o procedimientos
para diagnosticar una condición o enfermedad
Incluyen a personas que tienen (y no tienen)
signos o síntomas de la enfermedad o
condición
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Permiten a los investigadores probar hipótesis
biológicas en pacientes vivos y tienen la
posibilidad de modificar las normas asistenciales.
Permiten obtener información válida sobre el
efecto de intervenciones en salud que buscan
prevenir o tratar un problema.
Prevención
Dirigidos a encontrar mejores formas de prevenir
la enfermedad (o modificar el curso de la
enfermedad)
Determinar la eficacia de un agente o medida
Participan personas que no padecen la
enfermedad (excepto en casos de recurrencia)
Pueden incluir medicinas, vitaminas, vacunas,
cambios en hábitos o estilo de vida
Ensayos Clínicos
Investigación Clínica
ECA “estándar de oro”
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 ECA “estándar de oro”

• Grupo control
Ensayo clínico aleatorizado controlado • similares al inicio para que las diferencias al final
puedan ser atribuidas a la intervención

Nivel de evidencia más alto para demostrar que el

procedimiento (dental) que se realiza es el más • Aleatorizados
adecuado con los conocimientos científicos que
existen en ese momento
• Ciegos

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Aleatorización Ciego

Enmascaramiento

Minimiza el sesgo en la elección de la Desconocimiento de la identidad de la intervención

asignación del tratamiento y es la única forma
de controlar factores pronósticos
desconocidos
(tratamiento) que está recibiendo el sujeto
Utilizado para disminuir los sesgos que ocurren en un
ensayo clínico

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Desventajas

Costo

Ventaja Tiempo

Pregunta “limitada”

Puede exponerse a los sujetos a riesgos

Diseño capaz de comprobar hipótesis Los voluntarios pueden ser diferentes a las personas que no aceptan la
aleatorización
causales
Complejidad
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 ¿Porqué realizarlos?
Permiten obtener información válida sobre el efecto de
intervenciones en salud
Tienen el potencial de mejorar la calidad de vida y
controlar los costos a través de una cuidadosa
comparación de las alternativas de tratamiento
Ejercen influencia sobre la práctica de la odontología
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Patients' perception of recovery after third molar surgery following
postoperative treatment with moxifloxacin versus amoxicillin and clavulanic
acid: a randomized, double-blind, controlled study
PURPOSE: To analyze the impact of the postoperative administration of
moxifloxacin (MXF) on oral function and quality of life after third molar
(TM) surgery. MATERIALS AND METHODS: A single-center, prospective,
randomized, double-blind, controlled clinical trial was designed. The
study population consisted of 100 patients who underwent impacted
TM extractions. Patients were distributed into 2 groups of 50 individuals
each. Postoperatively, one group was administered MXF (400 mg/24
hours for 5 days); the positive control group received amoxicillin and
clavulanic acid (AMX-CLV) (500/125 mg/8 hours for 5 days). Follow-up
was performed for 7 postoperative days, during which the patient
recorded information on pain, the use of rescue analgesia, undesirable
effects of the medication, difficulty in speaking, difficulty in chewing,
diet consistency, difficulty performing oral hygiene, asthenia, time in
bed, going out of the house, and returning to work.
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Low intensity laser therapy in temporomandibular disorder: a
phase II double-blind study
The purpose of this study was to evaluate the analgesic effect of Low Intensity
Laser Therapy (LILT) and its influence on masticatory efficiency in patients
with temporomandibular dysfunction (TMD). This study was performed using
a random, placebo-controlled, and double-blind research design. Fourteen
patients were selected and divided into two groups (active and placebo).
Infrared laser (780 nm, 70 mw, 60s, 105J/cm2) was applied precisely and
continuously into five points of the temporomandibular joint (TMJ) area:
lateral point (LP), superior point (SP), anterior point (AP), posterior point (PP),
and posterior-inferior point (PIP) of the condylar position. This was performed
twice per week, for a total of eight sessions. To ensure a double-blind study,
two identical probes supplied by the manufacturer were used: one for the
active laser and one for the inactive placebo laser. They were marked with
different letters (A and B) by a clinician who did not perform the applications.
A Visual Analogue Scale (VAS) and a colorimetric capsule method were
employed. Data were obtained three times: before treatment (Ev1), shortly
after the eighth session (Ev2), and 30 days after the first application (Ev3).
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Diseños
Grupos paralelos
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Efficacy and safety of 10% and 16% carbamide peroxide tooth-
whitening gels: a randomized clinical trial
Ninety-two volunteers with a shade mean of C1 or darker for the six
maxillary anterior teeth were randomized into two balanced groups
(n=46) according to bleaching agent concentration: 10% (CP10) or 16%
(CP16) carbamide peroxide. The patients were instructed to use the
whitening agent in a tray for two hours once a day for three weeks.
Shade evaluations were done with a value-oriented shade guide and a
spectrophotometer at baseline and one week post-bleaching (four-
week evaluation). Tooth sensitivity was measured daily using a scale
ranging from 0 (no sensitivity) to 4 (severe sensitivity). At the end of the
study, the volunteers filled out a questionnaire with seven questions
aimed to give their opinion about the adopted treatment regimen.
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Sodium fluoride and chlorhexidine effect in the inhibition of mutans
streptococci in children with dental caries: a randomized, double-
blind clinical trial
Thirty-five healthy volunteers, aged 4-8 years, with at least one
active carious lesion and no previous history of allergies were
selected to participate in the study. A gel formulation containing
either 1.23% sodium fluoride or 1% chlorhexidine was topically
administered to the dentition every 24 h for 6 consecutive days.
Salivary MS levels were measured at baseline (D1) and on the
6th (D6), 15th (D15), and 30th (D30) days. For microbiological
analysis, Mitis Salivarius-Bacitracin agar medium was used.
4
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 Diseños Fluoride oral retention after professional topical application in
children with caries activity: effect of the immediate water
consumption
Cruzado
This blind randomized crossover in vivo study
involved children who received a professional APF
gel application followed by either drinking a glass of
water (experimental group) or without rinsing,
drinking, or eating (control group) for 2 hours. The
nonstimulated saliva was collected at 0, 5, 15, 30,
60, and 120 minutes following the professional APF
application. After a 7-day washout period, the
control and treatment groups were switched.

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Diseños
Clinical evaluation of the effects of a sonic toothbrush with
ultrasound waveguide in disrupting plaque
with and without bristle contact
PURPOSE: To assess the in vivo plaque removal efficacy of the newly
Split mouth
marketed sonic/ultrasonic toothbrush. Plaque removal resulting from the
toothbrush being held approximately 3 mm from the tooth surface was
compared versus a no brushing control. Also, plaque removal resulting from
the brush being used according to the manufacturer's instructions was
compared versus a control of using the brush (with power turned off) like a
manual toothbrush would be used. METHODS: This was a replicate use, four-
treatment, examiner-blind, randomized, eight-period crossover design single
brushing plaque study involving 31 subjects. The four treatment regimens
consisted of (1) brushing for 2 minutes with the Ultreo powered toothbrush
according to manufacturer's instructions, (2) brushing for 2 minutes with the
Ultreo toothbrush (power turned off) using the brush like a manual
toothbrush, (3) having a trained dental hygienist hold the Ultreo toothbrush
head 3 mm from tooth surfaces for a total of 2 minutes, or (4) swishing with a
dentifrice slurry for 1 minute in the absence of toothbrushing. For each
subject, an experienced, calibrated plaque examiner performed the Turesky
¡CUIDADO!
Modified Quigley-Hein Plaque Index prior to brushing and following brushing.

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The efficacy of a plasma arc light in orthodontic bonding:
a randomized controlled clinical trial
OBJECTIVE: To evaluate the clinical performance of a plasma arc light
(Ortho LITE, 3M Unitek, Monrovia, CA, USA) against a conventional
tungsten-quartz halogen curing light (Visilux 2, 3M Unitek, Monrovia,
CA, USA) for direct orthodontic bonding. DESIGN: A single centre
prospective randomized controlled clinical trial. SETTING: The
Orthodontic Department at St Luke's Hospital, Bradford, UK. SUBJECTS
AND METHODS: Forty-three consecutive patients requiring fixed
appliances from the orthodontic waiting list. A split mouth technique
was adopted; with quadrants randomly assigned to either the plasma
arc light or the conventional halogen curing light and bonded directly
with APC pre-adjusted edgewise brackets. MAIN OUTCOME MEASURE:
Bracket failures. SECONDARY OUTCOME MEASURES: Time taken to
bond-up the appliances, patient sensitivity or discomfort during curing
and time to replace failed brackets were investigated.
Three-year split-mouth randomized clinical comparison between
crowns fabricated in a titanium-zirconium
and a gold-palladium alloy
PURPOSE: The aim of this study was to compare the clinical
performance of metal-ceramic crowns made with an experimental
alloy prepared by the Nordic Institute of Dental Materials, containing
15% zirconium and 85% titanium (Ti-15% Zr), and a high noble gold-
palladium alloy (Mattikraft). MATERIALS AND METHODS: Twenty
patients who satisfied the inclusion criteria were selected sequentially
from the departmental waiting list. Each patient received 2 crowns in
the premolar or molar region. Which tooth was to receive a crown
based on gold-palladium alloy or Ti-15% Zr alloy was randomly
decided. A number of aspects indicating the clinical performance of
the crowns were recorded at baseline and after 1, 2, and 3 years.

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 Diseños Design of a community-based
intergenerational oral health study: "Baby
Barniz Gel
Smiles"
BACKGROUND: Rural, low-income pregnant women and their children are at high risk
Factorial for poor oral health and have low utilization rates of dental care. The Baby Smiles
study was designed to increase low-income pregnant women's utilization of dental
care, increase young children's dental care utilization, and improve home oral health
care practices.
METHODS/DESIGN: Baby Smiles was a five-year, four-site randomized intervention trial with
Cada 6 a 2 × 2 factorial design. Four hundred participants were randomly assigned to one of four
treatment arms in which they received either brief Motivational Interviewing (MI) or health
meses ?
education (HE) delivered during pregnancy and after the baby was born. In the prenatal
study phase, the interventions were designed to encourage dental utilization during
pregnancy. After childbirth, the focus was to utilize dental care for the infant by age one.
The two primary outcome measures were dental utilization during pregnancy or up to two
Cada 12 months postpartum for the mother, and preventive dental utilization by 18 months of age
for the child. Medicaid claims data will be used to assess the primary outcomes.
meses Questionnaires were administered at enrollment and 3, 9 and 18 months postpartum (study
end) to assess mediating and moderating factors.

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Statistical analysis of salivary pH changes after the

intake of black tea and yerba maté supplemented Validez externa
with sweeteners
Grado con el cual las conclusiones serían verdad
Many studies have demonstrated the effect of various para otras personas en otros lugares (y en otro
beverages on hard tissues of the mouth. Sugar consumption tiempo)
has also been avoided because it is associated with caries
activity, and artificial sweetener research has been promoted. Universo
In this paper, data about the buffer capacity of black tea and
yerba mate supplemented with sugar or one of two artificial
sweeteners (Barny diet and NutraSweet) were examined.
Salivary pH variations after the ingestion of both infusions
were statistically analysed. A factorial design of four variables
Muestra
(Infusion, Sweetener, Concentration and Time) and their
effects were considered independently and combined.

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Validez de constructo Validez interna

Se refiere a que si lo que se dice está originando un
cambio realmente lo está causando
Busca que las mediciones midan lo que
Se relaciona con la CALIDAD del experimento
realmente se intenta medir.
Se logra cuando hay control, cuando los grupos difieren
Aplica a las variables y a todo lo que pudiera entre sí solamente en la exposición a la variable
independiente, cuando las mediciones de la variable
afectar a las variables . dependiente son confiables y válidas, y cuando el
análisis es el adecuado.
6

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 Validez de conclusión Implementación

Personal involucrado (definir responsabilidades)

Se relaciona al análisis estadístico
Reclutamiento (obtener suficientes participantes)

Planeación (logística)
Establece la relación entre la intervención y el
desenlace, si es que existe.
Adherencia de los participantes (toma de
medicamentos, asistencia, cumplir con
indicaciones)

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Realización

Etapa más larga

La más demandante

La más ingrata

Sujeta a:
Descuidos
Críticas
Aburrición

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