NCT05895292

Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges

Digital Analysis of Denture Space Confines and Patient's Satisfaction for Conventional Versus Neutral-Zone CAD/CAM Dentures Restoring Mandibular Resorbed Ridges.(Randomized Controlled Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The study is a within-subject randomized clinical trial that will compare and evaluate patients' satisfaction and digitally analyze denture space Confines. Group I: CAD/CAM. (computer-aided design/computer-aided manufacturing) Conventional complete dentures will be designed based on the bone support concept, Group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The participants will be selected according to inclusion and exclusion criteria and will be randomly allocated into both groups and then shuffled to the other group using the Research Randomizer Program.

Detailed description

This study is designed as a randomized clinical trial applying a within-subject comparison of two different complete denture types as follows; group I: CAD/CAM conventional complete dentures will be designed based on the bone support concept, group II: CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept. The study will be carried out on twelve completely edentulous patients exhibiting advanced residual ridge resorption, each patient will receive two sets of complete dentures in a random sequence, and each set of CDs will be worn for at least eight weeks after the last recall visit before assessments. Upon delivery of the second set of CDs, the first set will be withheld from the patient. For each denture set, patient satisfaction will be rated using a patient denture assessment PDA questionnaire that will be assessed via a Likert scale, the obtained scores will be used to compare the two denture types. Also by using special digital software, a comparison between group I and II virtual complete denture images will be conducted.

Conditions

• Denture, Complete

Interventions

Type	Name	Description
DEVICE	CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.	The patients will receive complete removable dentures designed based on the bone-support concept and digitally manufactured using a milling machine.
DEVICE	CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.	The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machine

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-06-08
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt