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

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

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.

Study Overview

• Status: Completed
• Conditions: Denture Retention
• Intervention / Treatment: Device: PEEK clip; Device: Nylon clip

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • MTI University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PEEK clip; Clip for overdenture retention made from poly-ether-ether-ketone (PEEK)	Device: PEEK clip; The overdentures were attached with PEEK clip . The retention of overdenture was assessed
Other: Nylon clip; Clip for overdenture retention made from nylon (C6H11NO)n	Device: Nylon clip; The overdentures were attached with Nylon clip . The retention of overdenture was assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: MTI University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neurotransmitter Agents; Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
• Other Study ID Numbers: 970/6525

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No