The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture

NCT06866067 | Completed

• 1 other identifier: 970/6525
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study is aiming to evaluate the retention of implant supported mandibular overdenture using two different clip materials namely polyoxymethylene (POM) and poly-ether-ether-ketone (PEEK) on PEEK bar at three-time intervals; immediately after placement, after 3 months and after 6 months.

Conditions

Denture Retention

Outcome Measures

Primary Outcomes (1)

• Overdenture retention assessed using Universal Testing Machine (Newton)

  Denture resistance corresponding to vertical displacement force was obtained using a universal testing machine (INSTRON, United States) to measure retention. Each patient had his chin securely fixed on a support while seated upright. The attachment portion of the universal machine was adjusted in accordance with the device's bar being securely attached to the denture. The device gradually increased the vertical load by 10 mm per minute until the denture completely fell out of place. A tuck sound can be heard to indicate the load at the dislodgment point. Additionally, the force plot in the recorded computer software data exhibits an abrupt drop (Nexyge; Lloyd Instruments; MT-4.6). Each test was repeated five times to obtain five records, and the mean of these records was calculated. Testing was carried out on the mandibular overdenture after insertion, as well as at 3 and 6 months.

  From enrollment and after 3 months and finally at the end of treatment at 6 months

Study Arms (2)

PEEK clip

OTHER

Clip for overdenture retention made from poly-ether-ether-ketone (PEEK)

Device: PEEK clip

Nylon clip

OTHER

Clip for overdenture retention made from nylon (C6H11NO)n

Device: Nylon clip

Interventions

PEEK clip DEVICE

The overdentures were attached with PEEK clip . The retention of overdenture was assessed

PEEK clip

Nylon clip DEVICE

The overdentures were attached with Nylon clip . The retention of overdenture was assessed

Nylon clip

Eligibility Criteria

• Age: 50 Years - 60 Years
• Gender Eligibility Details: bone density
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male.
• Completely edentulous.
• Age: 50-60 years.
• Free from any systemic diseases that affect bone metabolism.
• Good intraoral condition.
• Anterior mandibular bone height \> 13mm and width \> 5mm.
• The inter-arch space from 15mm to 17mm.

You may not qualify if:

• Smoking and drug abusing.
• Severe maxillomandibular skeletal discrepancy.
• Bone metabolic disorders.
• History of head and neck radiotherapy.
• Intravenous bisphosphonate therapy.
• Presence of para-functional habits.
• Temporomandibular joint disorders.
• Severe bony undercuts.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

MTI University

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Removable Prosthodontics

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 10, 2025
• Study Start: February 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: March 10, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)