NCT06324292

Brief Summary

The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction. It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

March 15, 2024

Last Update Submit

March 23, 2024

Conditions

Complete Edentulism

Outcome Measures

Primary Outcomes (1)

  • quality of life assessment

    OHIP-19 questionnaires for the edentulous patient will be used. A likert scale from 0 to 5 will be employed which zero will denote the ' very bad" experience with the denture and 5 will denote the "excellent" experience

    3 months

Study Arms (2)

conventional denture followed by a digital one

ACTIVE COMPARATOR

the participants will receive a conventional complete denture followed by a digital one having digital smile design

Procedure: complete denture, CG

Digital denture followed by a conventional one

ACTIVE COMPARATOR

the participants will receive a digital complete denture having digital smile design followed by a conventional one

Procedure: complete denture, DG

Interventions

complete denture, CGPROCEDURE

fabrication of conventional complete denture followed by a digital denture

conventional denture followed by a digital one
complete denture, DGPROCEDURE

fabrication of digital complete denture followed by a conventional one

Digital denture followed by a conventional one

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • completely edentulous patients
  • well formed edentulous ridge
  • healthy, pink, non edematous mucosa of even thickness

You may not qualify if:

  • heavy smokers
  • patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders
  • patients with physicological or psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

Location

Faculty of Dentistry, Ain Shams University

Cairo, 11361, Egypt

Location

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

DenturesDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and Supplies

Study Officials

  • Ahmed MA Mohamed, BDS MSc MD

    Ain Shams University

    STUDY CHAIR

Central Study Contacts

Ahmed MA Mohamed, BSc MSc,MD

CONTACT

01111191337ahmedmostafa@dent.asu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: The participants allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of oral and maxillofacial prosthodontics

Study Record Dates

First Submitted

March 15, 2024

First Posted

March 21, 2024

Study Start

April 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 15, 2024

Last Updated

March 26, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study protocol and statistical analysis plan will be available matching the criteria of the journal. However, data will be available from the corresponding author upon request once the paper is published.
Access Criteria
data will be available from the corresponding author upon request once the paper is published.

Locations

EG(2)