Patient Satisfaction With Different Numbers of Implants

Assessment of Patient Satisfaction in Completely Edentulous Patients Receiving Removable Implant Overdentures Retained by Different Numbers of Implants .A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction
• Intervention / Treatment: Other: implants supported overdentures

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11351
    • Doaa Mahmoud Elkady
  • Cairo, Egypt, 11351
    • Nesma Mohamed Awaad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria

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

Exclusion criteria

• Exclusion Criteria:
• uncontrolled diabetes
• bruxers
• smokers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; single impalnts supported overdenture	Other: implants supported overdentures; implant supported and retained with different number of implants retained by ball attachments
Active Comparator: active comparator; two implants supported overdenture	Other: implants supported overdentures; implant supported and retained with different number of implants retained by ball attachments
Other: others; four implants supported overdenture	Other: implants supported overdentures; implant supported and retained with different number of implants retained by ball attachments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction for masticatory ability, mental life comfortability with dentures	A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects, Each response was given a score range from 0 to 4 where zero represents the best result . Questionnaire was divided into three categories questions, the first section was a direct questions to the patient answered by one of some choices, and each choice had a number which will be summed up and giving a score, The second section was a visual answered question; in which patient chose from best to worst on a given scale. The marked point will be translated into a number from zero (the best) to ten (the worst). The third section was a YES/ NO questions, answered shortly by the patient in the terms of yes or No. A translated into Arabic form of patient satisfaction questionnaire to match the language and environmental background of the patients was answered by all subjects	one year

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Doaa Elkady phd, Lecturer

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2021
• Primary Completion (Actual): January 10, 2023
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: May 20, 2023
• First Submitted That Met QC Criteria: May 30, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 33922

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No