Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems

Обзор

Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients

Подробное описание

This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI. Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.

Вмешательства

• Другое Crossover Assignment
  Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region. Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.

Первичные конечные точки

• Retention Force of Implant Overdentures (IODs) [Срок оценки: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures]
• Denture Wear of Implant Overdentures (IODs) [Срок оценки: Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up]
• Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores) [Срок оценки: Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months]
• Crestal bone level changes [Срок оценки: Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months]
• Oral Health-Related Quality of Life (OHIP-19 score) [Срок оценки: OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up]
• Patient Satisfaction (Visual Analog Scale Score) [Срок оценки: VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up]

Критерии участия

Критерии включения

• Completely edentulous patients
• Non-smokers
• Patients free from intra-oral diseases that may affect implant-overdenture prognosis
• Patients free from systemic conditions that may influence bone resorption or implant success
• Able and willing to comply with study visits and follow-up schedule

Критерии исключения

• Smokers or tobacco users
• Presence of active oral lesions, infections, or mucosal pathology
• Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
• History of head and neck radiation
• Severe parafunctional habits (e.g., bruxism)
• Inability to attend follow-up appointments or provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Египет · 1 центр

• Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch) — Asyut

Идентификаторы

NCT: NCT07580534 · Al-Azhar University, (Assiut B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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