Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

Официальное название

Clinical and Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Cap Attachment: Randomized Control Clinical Trial

Обзор

This clinical study is being conducted at Cairo University to evaluate two different types of attachments used with implant-supported dentures in the mandible. Patients who have lost all their teeth in the lower jaw receive implants to help hold their dentures in place. This study compares two types of attachments for connecting the denture to the implants: 1. Bar attachment only, which is a traditional method. 2. Bar with OT Cap attachment, which is a newer design that includes a small sphere (cap) to help with retention and comfort. The purpose of this study is to find out which attachment type works better in terms of: 1. How well the denture stays in place (retention) 2. How much bone is lost around the implants over time (crestal bone loss) 3. How much the attachment parts wear out (cap wear) 4. How satisfied the patients are with their dentures The study is a randomized controlled trial. This means participants will be randomly assigned to one of the two groups (bar-only or bar with OT Cap). All participants will receive complete dentures and three dental implants in the lower jaw. Follow-up will include measurements of denture retention and cap wear at the time the denture is inserted and again after 6 months. Bone loss will be checked with digital X-rays, and patient satisfaction will be assessed using a short questionnaire. The study will include 22 participants (11 in each group), aged 30 to 65, who are healthy and have enough bone in the jaw to support implants. This study is designed to help dentists and patients make better decisions about which type of implant attachment provides better long-term results and patient comfort.

Подробное описание

This randomized controlled clinical trial is designed to evaluate and compare the clinical and radiographic outcomes of two mandibular implant-supported overdenture attachment systems: (1) conventional bar attachment, and (2) bar with OT Cap (sphere) attachment. The objective is to determine which system provides superior performance in terms of prosthesis retention, crestal bone preservation, attachment wear, and patient satisfaction.

A total of 22 completely edentulous participants, aged between 30 and 65 years and meeting strict inclusion criteria, will be enrolled. Each participant will receive three endosseous implants placed in the anterior mandibular region (midline and canine positions). Following a four-month osseointegration period, participants will be randomly allocated (1:1) to one of two intervention groups: Group A (bar attachment only) and Group B (bar with OT Cap sphere attachments).

The prosthetic protocol involves the fabrication and delivery of maxillary and mandibular complete dentures, followed by intraoral placement and pick-up of the attachment systems. The primary outcome is denture retention, assessed at baseline (T0) and after 6 months (T6) using a digital force gauge. Secondary outcomes include crestal bone loss (evaluated via standardized digital radiographs), cap wear (measured using electron microscopy), and patient satisfaction (assessed using a validated Visual Analog Scale questionnaire).

Randomization will be conducted using a computer-generated sequence with allocation concealment ensured via opaque sealed envelopes. Due to the nature of the intervention, blinding of participants and clinicians is not feasible; however, outcome assessment and statistical analysis will be performed by a blinded examiner.

This study addresses a critical gap in the comparative assessment of attachment systems for implant-retained mandibular overdentures. While bar attachments are widely used for their rigidity and implant splinting capacity, recent innovations such as the OT Cap aim to enhance retention and reduce maintenance through added resilience. By directly comparing these two configurations in a controlled setting, the study aims to contribute clinically relevant data to guide prosthodontic treatment planning for edentulous patients.

Вмешательства

• Устройство Conventional Bar Attachment
  A rigid cast bar attachment fabricated and screwed onto three mandibular implants (placed at the midline and canine areas). The bar connects the implants to provide splinting and retention for a mandibular overdenture without the use of additional retentive components such as OT Caps. The overdenture is adjusted to fit passively over the bar and picked up intraorally.
• Устройство Bar with OT Cap Attachment
  A cast bar attachment fitted with two OT Cap attachments, which are designed to improve prosthesis retention and load distribution. This bar system is installed on three mandibular implants (midline and canine regions). The mandibular overdenture is relined to incorporate the female retentive caps that snap onto the OT Caps. This system combines the splinting benefits of the bar with the resilient retention of stud attachments.

Первичные конечные точки

• Retention of Mandibular Implant-Supported Overdenture [Срок оценки: Baseline (T0) and 6 months after overdenture insertion (T6)]

Вторичные конечные точки (3)

• Crestal Bone Loss Around Implants [Срок оценки: Baseline (T0) and 6 months after overdenture insertion (T6)]
• Attachment Cap Wear [Срок оценки: Baseline (T0) and 6 months after overdenture insertion (T6)]
• Patient Satisfaction with Overdenture [Срок оценки: 6 months after overdenture insertion (T6)]

Критерии участия

Критерии включения

• Completely edentulous healthy patients
• Age between 30 and 65 years
• Adequate bone volume in the anterior and premolar-molar region (minimum 11 mm)
• Adequate inter-arch space (12-14 mm)

Критерии исключения

• Severe maxillomandibular skeletal discrepancy
• Parafunctional habits (e.g., clenching, bruxism)
• Temporomandibular joint disorders
• Heavy smokers (≥20 cigarettes/day)
• History of head and neck radiation
• History of chemotherapy
• Systemic conditions that may interfere with healing or bone quality (e.g., uncontrolled diabetes, osteoporosis, bisphosphonate therapy)
• Drug abuse or alcohol dependence

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: NCT07067190 · MF-OTBarRCT2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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