Relining Assessment of Digital and Conventional Fabricated Complete Denture Base

NCT05955989 | Unknown

• 1 other identifier: 14860202023
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Problem With Dentures

Keywords

Relining; Milled denture; 3D-print; complete dentures

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Patient Satisfaction

  on day one of denture insertion and on the 9th month of denture insertion ( end of the follow up period)

Study Arms (3)

Complete denture fabricated from Conventional heat curing

ACTIVE COMPARATOR

The patients in this group will receive complete dentures fabricated by conventional heat curing method. and they will receive soft lining of the complete dentures after one year.

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

complete denture fabricated by CAD/CAM milled technology

ACTIVE COMPARATOR

The patients in this group will receive complete dentures fabricated by CAD/CAM ( Computer aided design/ Computer aided manufacture) method. and they will receive soft lining of the complete dentures after one year.

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

complete denture fabricated by CAD/CAM 3D Printed technology

ACTIVE COMPARATOR

The patients in this group will receive complete dentures fabricated by 3D printing ( three dimension) method. and they will receive soft lining of the complete dentures after one year.

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

Interventions

soft lining of complete denture processed by 3 different techniques. OTHER

soft lining for complete denture

Complete denture fabricated from Conventional heat curing; complete denture fabricated by CAD/CAM 3D Printed technology; complete denture fabricated by CAD/CAM milled technology

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients have severe bony undercut.
• Uncooperative patients.
• Patients having radiation to the head and neck region.
• Smoker patients.

Sponsors & Collaborators

• Asmaa Nabil Elboraey: lead
• National Research Centre, Egypt: collaborator

Study Sites (1)

National Research Centre

Cairo, Dokki, 12622, Egypt

Location

Study Officials

• Asmaa N. Elboraey, Asso, Prof

  National Research Centre, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the patient is not know the type of prosthesis he will receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Three groups of completely edentulous patients. Each group will receive complete denture processed with different technique. After one year the patients will recalled and relining of the denture were made to gain the retention. After one year assessment of retention by digital force gauge, occlusion equilibrium by T-Scan and patient satisfaction (PS)

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 21, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)