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Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction

NCT ID: NCT06678945

Last Updated: 2024-12-16

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-02-01

Brief Summary

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The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.

Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)

Detailed Description

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patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.

Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.

Conditions

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Edentulous Alveolar Ridge Complete Edentulism Dental Implant Attachments Implant Supported Overdenture Edentulous Mouth Edentulous Jaw

Keywords

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Dental Implants Completely edentulous patients Edentulous Ridge

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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Bar-Clip attachment

on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture

Group Type ACTIVE_COMPARATOR

Bar-Clip attachment

Intervention Type PROCEDURE

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.

Bar- OT Equator attachment

on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture

Group Type EXPERIMENTAL

Bar- OT Equator attachment

Intervention Type PROCEDURE

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.

Interventions

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Bar-Clip attachment

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.

Intervention Type PROCEDURE

Bar- OT Equator attachment

The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients age must range from 60- 70 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

60 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

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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Cairo University

Giza, Al Saraya, Old Cairo, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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27 4 24

Identifier Type: -

Identifier Source: org_study_id