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NCT05882617 Clinical Trial

Patient Satisfaction With Different Numbers of Implants

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05882617
Other study ID # 33922
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2021
Est. completion date January 10, 2023

Study information
Verified date June 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• implants supported overdentures
implant supported and retained with different number of implants retained by ball attachments

Locations
Country Name City State
Egypt Doaa Mahmoud Elkady Cairo
Egypt Nesma Mohamed Awaad Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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