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

NCT ID: NCT07241481

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ball & Socket Attachment

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

Group Type ACTIVE_COMPARATOR

Ball & Socket Attachment

Intervention Type 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

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

Group Type EXPERIMENTAL

Equator Attachment

Intervention Type PROCEDURE

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

Interventions

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Ball & Socket Attachment

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

Intervention Type PROCEDURE

Equator Attachment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

1. Patients with oral or systemic diseases.
2. Patients with xerostomia or excessive salivation.
3. Patients with parafunctional habits (bruxism or clenching).
4. Heavy smoker or alcoholic patients.
5. Patients with history of temporo-mandibular dysfunction.
6. Patients with brain disorders or psychiatric disorders
Minimum Eligible Age

55 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Noha Taha Kamel Taha Alloush

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oral and Dental Research Institute, National Research Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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03410625

Identifier Type: -

Identifier Source: org_study_id

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