Patient Satisfaction With Different Numbers of Implants

NCT ID: NCT05882617

Last Updated: 2023-06-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-12

Study Completion Date

2023-01-10

Brief Summary

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the goal of this randomized controlled trial aimed to assess patient satisfaction for completely edentulous patients with implant overdenture retained by ball attachment over a single symphyseal , or four interforaminal implants when compared to two interforaminal ones

Detailed Description

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48 edentulous patients were recruited and randomized to receive either 1,2 or 4 implants for a mandibular overdenture,3 months later implants were uncovered, and ball attachments were torqued, and all overdentures were picked up ,patient satisfaction questionnaires were recorded for all patients 2 weeks after pickup 3 months ,6 months, 9 months and 1year.

Conditions

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Patient Satisfaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

three parallel arms one comparator and two interventions
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
only statistician was masked

Study Groups

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experimental

single impalnts supported overdenture

Group Type EXPERIMENTAL

implants supported overdentures

Intervention Type OTHER

implant supported and retained with different number of implants retained by ball attachments

active comparator

two implants supported overdenture

Group Type ACTIVE_COMPARATOR

implants supported overdentures

Intervention Type OTHER

implant supported and retained with different number of implants retained by ball attachments

others

four implants supported overdenture

Group Type OTHER

implants supported overdentures

Intervention Type OTHER

implant supported and retained with different number of implants retained by ball attachments

Interventions

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implants supported overdentures

implant supported and retained with different number of implants retained by ball attachments

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* completely edentulous patients with restorative space of 12-15 mm,
* keratinized gingiva of 5 mm

Exclusion Criteria

* uncontrolled diabetes
* bruxers
* smokers
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nesma Mohamed awaad

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa Elkady phd

Role: STUDY_DIRECTOR

lecturer

Locations

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Doaa Mahmoud Elkady

Cairo, , Egypt

Site Status

Nesma Mohamed Awaad

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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33922

Identifier Type: -

Identifier Source: org_study_id

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