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

NCT07241481 | Completed DMC

• 1 other identifier: 03410625
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulous Alveolar Ridge In Mandible; Complete Edentulism; Dental Implant; Attachments; Implant Retained Overdenture; Edentulous Jaw

Keywords

Dental Implants; Attachments; Edentulous Ridge

Outcome Measures

Primary Outcomes (1)

• Marginal Bone Changes

  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

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

Secondary Outcomes (1)

• Occlusal force distribution measurement

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

Study Arms (2)

Ball & Socket Attachment

ACTIVE COMPARATOR

On the 2nd stage, implants will be loaded with ball \& socket attachments to retain overdenture

Procedure: Ball & Socket Attachment

Equator Attachment

EXPERIMENTAL

On the 2nd stage, implants will be loaded with Equator attachments to retain overdenture

Procedure: Equator Attachment

Interventions

Equator Attachment PROCEDURE

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

Equator Attachment

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

Ball & Socket Attachment

Eligibility Criteria

• Age: 55 Years - 60 Years
• Gender Eligibility Details: Male patients aged between 55 and 60 years with completely edentulous maxillary and mandibular arches were included in the study. All participants demonstrated good oral hygiene, an Angle Class I maxilla-mandibular relationship, and adequate interarch space. The residual alveolar ridges were covered by firm, healthy mucosa without signs of inflammation, ulceration, or flabbiness.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Oral and Dental Research Institute, National Research Center

Cairo, 4470351, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: July 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 2, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: After publication End Date: 3 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)