Impacto del Control Glucémico en la Supervivencia de Implantes Dentales en Pacientes con Diabetes Tipo 2
Este estudio tiene como objetivo observar el impacto del control glucémico en la supervivencia de implantes dentales en individuos con diabetes tipo 2, enfocándose en complicaciones tales como infección, inflamación, pérdida ósea y falla del implante a través de evaluaciones clínicas a largo plazo cada 6 meses.
Colección de datos
Recopilados desde hoy en adelante - ProspectivoDiabetes Mellitus Tipo 2+2
+ Enfermedades del Sistema Endocrino
+ Diabetes Mellitus
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 1 de mayo de 2014
Fecha en la que se inscribió al primer participante.This single-center prospective observational cohort study seeks to clarify the role of glycemic control as a risk determinant for survival of dental implants and biologic complications of dental implant therapy in patients with type 2 diabetes. Long-term implant stability and implant-related complications will be assessed in relation to glycated hemoglobin levels over time in poorly-controlled and well-controlled diabetics and in non-diabetic participants. Primary: To determine the impact of glycemic control in type 2 diabetes patients on implant-related biologic complications, integration and survival for dental implants under long-term functional loading (>1 year). Secondary: To examine these associations relative to long-term effects of sub-optimal glycemic control on two different anatomic/restorative schemes (fixed partial or removable complete) Outcomes: Assessments include implant survival, implant-related biologic complications and resonance frequency analysis as a measure of implant stabilization. Outcomes will be analyzed relative to glycated hemoglobin levels (HbA1c) taken at 6-month intervals over the course of the study. The total study population will consist of 163 participants who will be followed for at least 2 years. This will include enrolling from a group of 141 patients who have previously received implant therapy as part of short-term assessments regarding diabetes. In addition, the study plans to enroll 42 participants who would benefit from implant supported denture therapy as done in the prior studies. These participants will be classified into 3 separate groups depending on the A1C reading at time of implant placement. The criteria being followed for the groups are HbA1c< 6.0% (non-diabetic), 6.0%<HbA1c<8.0% (well controlled diabetic) and 8.0%<HbA1c<12.0% (poorly controlled diabetic). A review of the potential participant's health is completed at the time of screening. The implant surgeon will determine if a patient is healthy for surgery with no anticipated health complications. If a health concern is evident that precludes implant placement, the patient will be excluded from study participation. The age requirement for the study is 25 years of age or older. It is expected that most participants will be 50 years and over due to the specific clinical requirements for the treatment being followed. Individuals of any gender, race, and ethnicity may participate in this study. Most patients live locally in San Antonio, TX and some are from the surrounding cities.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 171 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 25 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * • Provide signed and dated informed consent form. * Willing to comply with all study procedures and be available for the duration of the study. * For participants with existing implant therapy: participated in either of two previous observational diabetes-implant studies that monitored implant outcomes and glycemic levels as conducted by Dr. Oates \[IRB study #s: HSC20070499H \& HSC20080156H\]. * For edentulous participants without existing implant therapy: Diagnosis of type 2 diabetes mellitus occurring more than 1 year prior to enrollment (self-reported and verified with physician report, test results, and/or treatment record) or healthy, non-diabetic with a HbA1c \< 6.0%, or either FPG \< 100 mg/dl or an OGTT \< 140 mg/dl (2 hr) within 11 months prior to surgery; participants must have complete maxillary and mandibular dentures determined to be clinically acceptable by study dentists; and must have an identified need for 2-implant supported mandibular overdenture using standard diameter Straumann 4.1 mm implants. * Male or female, aged 25 to 99. * HbA1c \<12%. * Women of reproductive potential must report a negative urine pregnancy test within 2 weeks of enrollment in study, and agree to use highly effective contraception during study period. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, the contraceptive ring, and condoms. Exclusion Criteria: * Medical condition, laboratory finding, or physical exam finding that precludes implant placement or therapy (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders). * Current medications or history of treatment known to have an effect on bone turnover, including: calcitonin, systemic steroids, bisphosphonates, estrogen or progesterone therapy. * Presence of acute untreated oral infections or inflammatory lesions. * History of HIV infection, Hepatitis B or C as determined by patient report or medical record. * Self-reported history of illicit drug use or alcohol abuse (Appendix D). * Implant site has had bone grafting procedures using autogenic or allogenic materials less than one year prior to placement, or requires bone grafting in conjunction with implant placement. * Implant site has had alloplastic grafting procedures. * Presence of a disease that affects bone metabolism, such as but not limited to: hyperthyroidism, hyperparathyroidism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease. * Participation in a clinical study that may interfere with participation in this study during the implant surgical phase and healing 4 months following placement. * Self-reported current tobacco use * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
University of Texas Health Science Center At San Antonio
San Antonio, United StatesAbrir University of Texas Health Science Center At San Antonio en Google Maps