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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Edentulous Jaw
• Intervention / Treatment: Device: 0 degrees 3D printed upper complete dentures; Device: 45 degrees 3D printed upper complete dentures

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients above the age of 40
2. Patients with opposing full natural dentition or completely or partially edentulous arches
3. Opposing arch should be either having a set of full natural dentition or is restored by fixed partial dentures or implants
4. Cooperative patients that are willing to attend all follow-up periods.
5. 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:

1. Patients with any temporomandibular joint disorder or parafunctional habits
2. Patients with flabby or flat ridges
3. Patients with extreme anatomical limitations such as a large torus that requires surgical excision.
4. Patients with a history of allergy to dentures made of resins.
5. Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
6. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 6, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Jaw Diseases; Mouth, Edentulous; Jaw, Edentulous
• Other Study ID Numbers: 245326677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No