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

NCT06164366 | Unknown

• 1 other identifier: 245326677
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Denture retention

  6 months

Study Arms (2)

0 Degrees Group

EXPERIMENTAL

dentures will be printed at a 0 degrees build angle

Device: 0 degrees 3D printed upper complete dentures

45 Degrees Group

ACTIVE COMPARATOR

dentures will be printed at a 45 degrees build angle

Device: 45 degrees 3D printed upper complete dentures

Interventions

0 degrees 3D printed upper complete dentures DEVICE

3d printed dentures at a build angle of 0 degrees

0 Degrees Group

45 degrees 3D printed upper complete dentures DEVICE

3d printed dentures at a build angle of 45 degrees

45 Degrees Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients free from any systemic disease that might affect the health of the bone or of the mucosa eg diabetes

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share