Patient Satisfaction With Different Numbers of Implants

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05882617

Collaborator

(none)

Enrollment

Locations

Arms

23.9

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Patient Satisfaction	Other: implants supported overdentures	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

three parallel arms one comparator and two interventionsthree parallel arms one comparator and two interventions

Masking:

Single (Outcomes Assessor)

Masking Description:

only statistician was masked

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 12, 2021

Actual Primary Completion Date :

Jan 10, 2023

Actual Study Completion Date :

Jan 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

patient satisfaction for masticatory ability, mental life comfortability with dentures [one year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Doaa Mahmoud Elkady	Cairo		Egypt	11351
2	Nesma Mohamed Awaad	Cairo		Egypt	11351

Sponsors and Collaborators

Cairo University

Investigators

Study Director: Doaa Elkady phd, lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nesma Mohamed awaad, lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT05882617

Other Study ID Numbers:

33922

First Posted:

May 31, 2023

Last Update Posted:

Jun 5, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 5, 2023