Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

Problem With Dentures Clinical Trial

Official title:

Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05955989
• Other study ID #: 14860202023
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Description:

Dental prostheses fabricated using different digital technology have become popular in recent years. Computer-aided design and computer-aided manufacturing (CAD-CAM) technology provides two techniques, milled or 3D printed technique which simplified the complex dental laboratory procedures by digitalizing the prosthetic design and automating the manufacturing process. Digitally fabricated prostheses have been reported to have excellent accuracy factor that has been related to favorable clinical performance. However, bone resorption underneath any mucosa supported prosthesis is not avoidable. Resilient liners are required for most complete dentures after 6 to 12 months to improve adaptation to the underlying tissues and to reduce the force transmitted to the edentulous ridge during functionThe bond between the resilient denture liner material and the denture base is essential to improve complete denture accuracy and retention to the underlying ridge. The bonding characteristics between resilient denture reline materials and conventional Polymethyl methacrylate (PMMA) denture base polymers have been evaluated extensively. But with the introduction of digital fabricated complete denture, the bond characteristics between digitally fabricated dentures and denture liner is sparse.

Therefore, the aim of this project is to evaluate the bond strength and effectiveness of denture reline of CAD/CAM (milled and 3D printed ) fabricated complete dentures compared to conventional heat-polymerized denture base.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients are free from any systemic diseases that might affect neuro-muscular control.

• Patients having class I maxilla-mandibular relationship

• Patients having healthy mucosa and normal salivary flow

Exclusion Criteria:

• Patients have severe bony undercut.

• Uncooperative patients.

• Patients having radiation to the head and neck region.

• Smoker patients.

Related Conditions & MeSH terms

• Problem With Dentures

Intervention

Other:
• soft lining of complete denture processed by 3 different techniques.
soft lining for complete denture

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo	Dokki

Sponsors (2)

Lead Sponsor	Collaborator
Asmaa Nabil Elboraey	National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change in retentive force of the complete denture	assessment of complete denture retention by digital force gauge	on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Primary	Assessment of change in occlusal forces during the follow up period.	Assessment of occlusion equilibrium by Occlusense device	on 3rd month of denture insertion, on 6th month of denture insertion, on the 9th month of denture insertion
Secondary	Patient Satisfaction	a questionnaire was designed containing 5 questions regarding the following parameters: retention, comfort, appearance, phonetics and pain. Increasing the score meaning more patient satisfaction.	on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)