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Completed

NCT Number: NCT07241481

Using Two Different Attachments (Equator Vs Ball and Sockets) Retaining Mandibular Implant Overdenture in Order to See Bone Changes and Occlusal Force Distribution

Alveolar ridge resorption is an unavoidable consequence in complete denture wearers due to limited retention and stability. Implant-retained overdentures enhance retention, stability, and masticatory performance while reducing ridge resorption and improving patients' quality of life.

Among attachment systems, ball-type anchors have long been favored for their simplicity and cost-effectiveness. However, the Equator attachment has emerged as a refined alternative, providing superior retention and stability for implant overdentures.

Functional performance can be evaluated through electromyography, which records masticatory muscle activity, and the T-Scan system, which analyzes occlusal force distribution and timing during dynamic occlusion. Additionally, bite force measurement serves as a key indicator of prosthetic efficiency and neuromuscular function, with implant-retained overdentures showing higher values than conventional dentures. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments.

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Key information

Conditions

Edentulous Alveolar Ridge in Mandible Attachments Complete Edentulism Dental Implant Edentulous Jaw Implant Retained Overdenture Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

55 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Oral and Dental Research Institute, National Research Center

Cairo, 4470351, Egypt

About this study

All 24 patients will receive upper complete and lower complete overdentures. The upper complete denture will be mucosa supported while lower complete denture will be retained for by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Ball and Socket attachment, while Group II will be retained by Equator attachment. Both groups will be functionally loaded after three months of insertion. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments. Bone level changes will be measured using CBCT, While occlusal force will be measured using Tscan system.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients age must range from 55- 60 years old.
  • All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
  • Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
  • All patients must have sufficient inter arch space

Exclusion criteria

  • Patients with oral or systemic diseases.
  • Patients with xerostomia or excessive salivation.
  • Patients with parafunctional habits (bruxism or clenching).
  • Heavy smoker or alcoholic patients.
  • Patients with history of temporo-mandibular dysfunction.
  • Patients with brain disorders or psychiatric disorders

Treatment and study plan

Ball & Socket Attachment

Procedure

Two implants will be restored using ball-and-socket attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings

Equator Attachment

Procedure

Two implants will be restored using Equator attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings

Primary outcomes

  1. Marginal Bone Changes

    Time frame: it will be measured at denture insertion, 6 month, and 12 month later

    Marginal bone height changes around the two implants were evaluated through the software by measuring the distance from the alveolar crest to the implant apex in both coronal and sagittal views. The amount of bone loss was calculated by subtracting the measured distance between each radiographic evaluation made at the time of denture insertion and the recall appointments by superimposition of images and average was taken

Secondary outcomes

  1. Occlusal force distribution measurement

    Time frame: it will be recorded at the time of prosthesis insertion, 6 months, and 12 months after denture insertion.

    Occlusal force distribution was done using the T-Scan™ Novus™, which consists of a sensor registering occlusal contacts, a data transferring module linked to a computer, and a software program to send data to the computer and visualize them on the monitor

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Bone Changes and Occlusal Force Distribution (Randomized Clinical Trial)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2025
Registry last updated
Apr 2, 2026

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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