Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

NCT ID: NCT07067190

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

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.

Conditions

Edentulous Mandible; Implant-Supported Overdentures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bar Attachment Group

Participants in this group will receive mandibular implant-supported overdentures retained by a conventional cast bar attachment. Three implants will be placed in the anterior mandible (midline and canine positions), and a single bar will be fabricated and attached to the implants. The overdenture will be adjusted to fit over the bar with no additional retentive components. This group represents the standard treatment modality for implant-retained overdentures.

Group Type: ACTIVE_COMPARATOR

Conventional Bar Attachment

Intervention Type: DEVICE

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 Group

Participants in this group will receive mandibular implant-supported overdentures using a bar combined with two OT Cap (sphere) attachments for added retention. The same implant placement protocol will be followed as in the comparator group. The bar will include OT Cap housings, and the overdenture will be relined to incorporate the corresponding female caps. This intervention is designed to improve denture retention, reduce component wear, and enhance patient satisfaction.

Group Type: EXPERIMENTAL

Bar with OT Cap Attachment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisa Mohamed Farid Shaaban

OTHER

Sponsor Role: lead

Responsible Party

Maisa Mohamed Farid Shaaban

PhD Candidate, Department of Prosthodontics, Faculty of Oral and Dental Medicine, Cairo University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Maisa MF Shaaban Gomaa, PhD candidate

Role: PRINCIPAL_INVESTIGATOR

Faculty of Oral and Dental Medicine, Cairo University

Hamdy Abo El-Fotouh, Professor

Role: STUDY_CHAIR

Faculty of Oral and Dental Medicine, Cairo University

Noha Ali, Assistant Professor

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine, Cairo University

Ahmed Hamed, Lecturer

Role: STUDY_DIRECTOR

Faculty of Oral and Dental Medicine, Cairo University

Locations

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Central Contacts

Maisa MF Shaaban Gomaa, PhD Candidate

Role: CONTACT

maisa.gomaa@dentistry.cu.edu.eg

+201002730928

Maisa Farid

Role: CONTACT

maisafarid2013@gmail.com

Facility Contacts

Maisa MF Shaaban Gomaa, PhD candidate

Role: primary

maisa.gomaa@dentistry.cu.edu.eg

01002730928

Role: backup

maisafarid2013@gmail.com

Other Identifiers

MF-OTBarRCT2024

Identifier Type: -

Identifier Source: org_study_id