A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures

January 22, 2021 updated by: Hisham ElGabry, October University for Modern Sciences and Arts
Purpose: This study aimed to compare patients' satisfaction with mandibular overdentures retained by three-splinted implants and conventional complete dentures during a seven-year follow-up period. Materials and Methods: Thirty edentulous male patients (mean age: 60 years) were carefully selected and divided into two equal groups. All patients received a new set of complete dentures. (Group I) patients received three implants in the anterior mandible and were connected after three months with bars, clips and loaded. (Group II) patients' received conventional complete dentures. Patients' satisfaction was recorded for both groups at three weeks (baseline) and after 1, 3, 5 and 7 years. Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction. Results: satisfaction scores of Group I patients was found to be statistically significantly higher than that of Group II patients (p < .05) at 3, 5 and 7 years follow-up, meanwhile no statistically significant difference was found at baseline or after 12 months. Conclusions: The long-term results suggest that three implants-retained mandibular overdenture with a clip-bar attachment appears to be a successful rehabilitation strategy which is superior to conventional dentures for patients with advanced ridge resorption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 62 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing.

Description

Inclusion Criteria:

  • The inclusion criteria stipulated that patients must have been wearing dentures on a regular basis, have been edentulous for a minimum of 3-years, and are capable of reading and writing.

Exclusion Criteria:

  • insufficient bone volume to install three 13mm. interforaminal implants (Group I), insufficient interarch space. Patients with diabetes, osteoporosis, smokers, psychological problems of removable denture acceptance, gag reflex, absence of a maxillary complete denture and medical or physical considerations that would seriously affect the surgical procedure (Group I) or the follow-up period were also excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
Other: Patient Satisfaction
Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.
Group II
Other: Patient Satisfaction
Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: Seven years
Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.
Seven years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2013

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 25, 2020

Study Registration Dates

First Submitted

January 22, 2021

First Submitted That Met QC Criteria

January 22, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1224 (Lineberger Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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