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Completed

NCT Number: NCT06866067

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

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.

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Key information

Conditions

Denture Retention

Age range

50 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

MTI University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PEEK clip

Device

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

Nylon clip

Device

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

Primary outcomes

  1. Overdenture retention assessed using Universal Testing Machine (Newton)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

MTI University

Other

Registry information

Official study title

The Effect of Clip Material on the Retention of Implant Supported Mandibular Overdenture: Clinical Comparative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 10, 2025
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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