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

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06164366
• Other study ID #: 245326677
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Device:
• 0 degrees 3D printed upper complete dentures
3d printed dentures at a build angle of 0 degrees
• 45 degrees 3D printed upper complete dentures
3d printed dentures at a build angle of 45 degrees

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	denture adaptation	measured using 3d metrology software in terms of the root mean square (RMS) values of trueness and adaptation	4 weeks
Secondary	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