Loading search results

Outcome Measures

Primary Outcomes (1)

Retention of Mandibular Implant-Supported Overdenture
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.
Baseline (T0) and 6 months after overdenture insertion (T6)

Secondary Outcomes (3)

Crestal Bone Loss Around Implants
Baseline (T0) and 6 months after overdenture insertion (T6)
Attachment Cap Wear

Study Arms (2)

Bar Attachment Group

ACTIVE COMPARATOR

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.

Device: Conventional Bar Attachment

Bar with OT Cap Attachment Group

EXPERIMENTAL

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.

Device: Bar with OT Cap Attachment

Interventions

Conventional Bar AttachmentDevice

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 Attachment Group

Bar with OT Cap AttachmentDevice

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 Officials

Maisa MF Shaaban Gomaa, PhD candidate

Faculty of Oral and Dental Medicine, Cairo University

PRINCIPAL INVESTIGATOR

Hamdy Abo El-Fotouh, Professor

Faculty of Oral and Dental Medicine, Cairo University

STUDY CHAIR

Noha Ali, Assistant Professor

Faculty of Oral and Dental Medicine, Cairo University

STUDY DIRECTOR

Ahmed Hamed, Lecturer

Faculty of Oral and Dental Medicine, Cairo University

STUDY DIRECTOR

Study Design

Study Type

interventional

Phase

not applicable

Allocation

RANDOMIZED

Masking

SINGLE

Who Masked

OUTCOMES ASSESSOR

Masking Details

Only the outcomes assessor (statistician) will be blinded to group allocation to reduce assessment bias. Neither the participant nor the care provider can be blinded due to the visible nature of the intervention.

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: Two-arm randomized controlled clinical trial comparing bar-only attachment vs. bar with OT Cap attachment in mandibular implant-supported overdentures.

Sponsor Type

OTHER

Responsible Party

SPONSOR INVESTIGATOR

PI Title

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

Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Bar Attachment Group

Bar with OT Cap Attachment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

Bar Attachment Group

Bar with OT Cap Attachment Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations