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

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Complete Edentulism

Clinical Trial Details

NCT number	NCT06324292
Study type	Interventional
Source	Ain Shams University
Contact	Ahmed MA Mohamed, BSc MSc,MD
Phone	01111191337
Email	ahmedmostafa@dent.asu.edu.eg
Status	Not yet recruiting
Phase	N/A
Start date	April 1, 2024
Completion date	September 15, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms