Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers

Complete Edentulism Clinical Trial

Official title:

Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324292
• Other study ID #: FDASU-RecID112324
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: Ahmed MA Mohamed, BSc MSc,MD
• Phone: 01111191337
• Email: ahmedmostafa[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: September 15, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

Inclusion Criteria:

• completely edentulous patients

• well formed edentulous ridge

• healthy, pink, non edematous mucosa of even thickness

Exclusion Criteria:

• heavy smokers

• patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders

• patients with physicological or psychiatric condition

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Procedure:
• complete denture, CG
fabrication of conventional complete denture followed by a digital denture
• complete denture, DG
fabrication of digital complete denture followed by a conventional one

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo
Egypt	Faculty of Dentistry, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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