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

Not Applicable

Completed

• Conditions: Denture Retention

• Registration Number: NCT06866067
• Lead Sponsor: MTI University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-06
• Last Update Submitted: 2025-03-06
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Inclusion criteria:

  • 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.

Exclusion criteria:

• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overdenture retention assessed using Universal Testing Machine (Newton)	From enrollment and after 3 months and finally at the end of treatment at 6 months	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.

Trial Locations

Locations (1)

MTI University; 🇪🇬 Cairo, Egypt