Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 Degrees

Study Overview
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Brief Summary
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This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of 0 degrees versus 45 degrees.

Detailed Description
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This pilot study aims to compare the difference, if present in patient satisfaction, denture base adaptation and retention in 3d printed maxillary complete dentures fabricated at a build angle of zero degrees versus forty five degrees. Since there is no sufficient evidence surrounding the topic at hand, a randomized clinical trial must be conducted in an attempt to gap the clinical knowledge regarding printing orientation and its effect on denture base adaptation and patient satisfaction. The main question and the one that needs further investigations as stated by Goodacre would these differences in these build up angles have a true clinical effect on denture adaptation and denture retention

Official Title
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Patient Satisfaction and Adaptation of Maxillary Resin Dentures Printed at 0 Versus 45 Degrees Build Angle: A Randomized Pilot Cross-over Clinical Trial

Conditions
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Edentulous Jaw

Intervention / Treatment
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* Device: 0 degrees 3D printed upper complete dentures
* Device: 45 degrees 3D printed upper complete dentures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients above the age of 40 Patients with opposing full natural dentition or completely or partially edentulous arches Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants Cooperative patients that are willing to attend all follow-up periods. Patients with healthy attached mucosa of appropriate thickness free from any inflammation. 6- Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes Exclusion Criteria: Patients with any temporomandibular joint disorder or parafunctional habits Patients with flabby or flat ridges Patients with extreme anatomical limitations such as a large torus that requires surgical excision. Patients with a history of allergy to dentures made of resins. Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0 Degrees Group<br>dentures will be printed at a 0 degrees build angle | Device: 0 degrees 3D printed upper complete dentures<br>* 3d printed dentures at a build angle of 0 degrees<br>|
| Active Comparator: 45 Degrees Group<br>dentures will be printed at a 45 degrees build angle | Device: 45 degrees 3D printed upper complete dentures<br>* 3d printed dentures at a build angle of 45 degrees<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction | Measured through a questionnaire using a likert scale from 1 - 5 with 1 being extremely satisfied with the intervention and 5 being extremely satisfied with the intervention | 6 months | 
| denture adaptation | measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Denture retention | Measured using Kapur scoring system. The grading will follow a Scoring System with four possible scores for retention from least (0) to best retention (3) | 6 months |