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

Not Applicable

Not yet recruiting

• Conditions: Edentulous Jaw
• Interventions: Device: 0 degrees 3D printed upper complete dentures; Device: 45 degrees 3D printed upper complete dentures

• Registration Number: NCT06164366
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-08-06
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11
• Study Start: 2024-01
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0 Degrees Group	0 degrees 3D printed upper complete dentures	dentures will be printed at a 0 degrees build angle
45 Degrees Group	45 degrees 3D printed upper complete dentures	dentures will be printed at a 45 degrees build angle

Primary Outcome Measures

Name	Time	Method
patient satisfaction	6 months	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
denture adaptation	4 weeks	measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation

Secondary Outcome Measures

Name	Time	Method
Denture retention	6 months	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)