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

Ain Shams University

Status: Not yet enrolling

Conditions: Complete Edentulism

Treatments: Procedure: complete denture, CG; Procedure: complete denture, DG

Study type: Interventional

Funder types: Other

Identifiers

NCT06324292

FDASU-RecID112324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 40 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

conventional denture followed by a digital one

Active Comparator group

Description:

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

Treatment:

Procedure: complete denture, CG

Digital denture followed by a conventional one

Active Comparator group

Description:

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

Treatment:

Procedure: complete denture, DG