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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07241481
Enrollment
24
Registered
2025-11-21
Start date
2024-07-01
Completion date
2025-12-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dental Implants, Attachments, Edentulous Ridge

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.

Detailed description

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.

Interventions

PROCEDUREBall & 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

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
55 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Marginal Bone Changesit will be measured at denture insertion, 6 month, and 12 month laterMarginal 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

MeasureTime frameDescription
Occlusal force distribution measurementit 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026