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

Sponsor
October University for Modern Sciences and Arts (Other)
Overall Status
Completed
CT.gov ID
NCT04726540
Collaborator
(none)
30
84.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patient Satisfaction

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Other
Official Title:
A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular Overdentures
Actual Study Start Date :
Jan 12, 2013
Actual Primary Completion Date :
Jan 15, 2019
Actual Study Completion Date :
Jan 25, 2020

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Patient Satisfaction [Seven years]

    Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
58 Years to 62 Years
Sexes Eligible for Study:
Male
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • October University for Modern Sciences and Arts

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hisham ElGabry, Ass. Prof. Prosthodontics, October University for Modern Sciences and Arts
ClinicalTrials.gov Identifier:
NCT04726540
Other Study ID Numbers:
  • 1224
First Posted:
Jan 27, 2021
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hisham ElGabry, Ass. Prof. Prosthodontics, October University for Modern Sciences and Arts

Study Results

No Results Posted as of Jan 27, 2021