Patient Satisfaction With Different Numbers of Implants

NCT05882617 | Completed

• 1 other identifier: 33922
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Conditions

Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

experimental

EXPERIMENTAL

single impalnts supported overdenture

Other: implants supported overdentures

active comparator

ACTIVE COMPARATOR

two implants supported overdenture

Other: implants supported overdentures

others

OTHER

four implants supported overdenture

Other: implants supported overdentures

Interventions

implants supported overdentures OTHER

implant supported and retained with different number of implants retained by ball attachments

active comparator; experimental; others

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• uncontrolled diabetes
• bruxers
• smokers

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Doaa Mahmoud Elkady

Cairo, 11351, Egypt

Location

Nesma Mohamed Awaad

Cairo, 11351, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Doaa Elkady phd

  lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: only statistician was masked
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: three parallel arms one comparator and two interventions

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: May 31, 2023
• Study Start: January 12, 2021
• Primary Completion: January 10, 2023
• Study Completion: January 10, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)