Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Retention of Mandibular Implant-Supported Overdenture — Baseline (T0) and 6 months after overdenture insertion (T6)
  Retention will be measured using a digital force gauge that applies a vertical dislodging force to the mandibular overdenture. The force required to dislodge the denture from the attachments will be recorded in Newtons. Measurements will be performed at two time points: at the time of prosthesis insertion (T0) and six months post-insertion (T6). The retention values will be used to compare the effectiveness of bar-only versus bar with OT Cap attachment systems.

Trial sites (1)

Other trials for the same condition