Mandibular Implant Overdenture With Bar vs OT Equator: A Randomized Controlled Trial

Официальное название

Clinical And Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Equator Attachment: Randomized Controlled Trial

Обзор

This clinical study will evaluate two types of attachment systems used to support lower dentures in patients who have lost all their lower teeth. All participants will receive dental implants in the lower jaw, and a complete denture that attaches to these implants for better stability and comfort. The study compares two options: A traditional bar attachment A bar with additional OT Equator attachments, which are designed to improve denture retention and reduce wear Each participant will receive three implants in the lower jaw, and either a bar attachment alone or a bar with OT Equator attachments will be placed. The goal is to find out which method provides better retention of the denture, causes less bone loss around the implants, has less wear on the attachment parts, and leads to higher patient satisfaction. Participants will be followed over several months. Their denture retention will be tested using a digital force meter, bone levels will be measured through radiographs, cap wear will be examined using an electron microscope, and satisfaction will be recorded using a questionnaire. This study is being conducted at Cairo University and is self-funded by the primary investigator. Participation is voluntary and does not involve any financial cost to participants.

Подробное описание

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of mandibular implant-supported overdentures using two different attachment systems: bar attachment alone (control group) versus bar with OT Equator attachments (intervention group).

A total of 22 completely edentulous participants will be randomly assigned to either group. Each participant will receive three dental implants placed in the anterior mandible. After healing, bar attachments will be fabricated and delivered. In the intervention group, OT Equator attachments will be added to the bar to enhance retention and flexibility. All participants will receive complete upper and lower dentures.

The study's primary outcome is denture retention, measured using a digital force gauge. Secondary outcomes include crestal bone loss (assessed radiographically), cap wear (measured via electron microscopy), and patient satisfaction (evaluated with a Visual Analog Scale questionnaire).

This study will help inform clinical decisions regarding attachment systems for mandibular overdentures and may provide evidence for improved long-term function and patient-reported outcomes.

Вмешательства

• Устройство Bar Attachment
  A bar attachment supported by three mandibular implants (placed in the midline and canine regions) is used to retain a mandibular overdenture. The bar provides rigid splinting across the implants and allows retention using friction or clips, without additional attachment components. This serves as the control group.
• Устройство Bar with OT Equator Attachment
  A bar attachment supported by three mandibular implants is combined with two OT Equator attachments to enhance denture retention and allow slight vertical and rotational resilience. The OT Equator system includes metal housings and retentive nylon caps, intended to reduce cap wear and improve patient comfort. This is the experimental arm.

Первичные конечные точки

• Retention of Mandibular Overdenture [Срок оценки: At baseline (T0) and 6 months post-insertion (T6)]

Вторичные конечные точки (3)

• Crestal Bone Loss Around Implants [Срок оценки: At baseline (T0) and 6 months post-insertion (T6)]
• Cap Wear of Attachment System [Срок оценки: At baseline (T0) and 6 months post-insertion (T6)]
• Patient Satisfaction [Срок оценки: At 6 months post-insertion (T6)]

Критерии участия

Критерии включения

• Completely edentulous healthy patients.
• Age between 35 and 65 years.
• Sufficient bone in the anterior and premolar-molar regions (≥11 mm).
• Adequate inter-arch space (12-14 mm).

Критерии исключения

• Severe maxillomandibular skeletal discrepancy.
• Presence of parafunctional habits such as clenching or bruxism.
• Temporomandibular joint disorders.
• Smokers.
• History of drug abuse.
• History of head and neck radiation.
• Systemic disorders that could prevent surgery or affect bone quality (e.g., uncontrolled diabetes, osteoporosis).

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Oral and Dental Medicine, Cairo University — Cairo

Идентификаторы

NCT: NCT07121881 · HS-OTBarRCT2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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