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

Not Applicable

Recruiting

• Conditions: Denture, Complete
• Interventions: Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.; Device: CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.

• Registration Number: NCT05895292
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for a long period.
2. The age of patients ranges from 50 to 80 years old.
3. Patients with a resorbed mandibular ridge.
4. Patients with a Class I maxillo-mandibular relationship
5. Patients with adequate inter-arch space.
6. Patients with good neuromuscular control.
7. Patients without any tempo-mandibular disorder.

Exclusion Criteria

1. Patients with any oral diseases that may affect complete denture construction
2. Patients with bad oral hygiene.
3. Patients with oral parafunctional habits.
4. Hysterical patients.
5. Patients will undergo or have previously received chemotherapy or radiotherapy.
6. Drug-addicted patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.	CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.	The patient will be provided by a complete removable denture designed according to bone-support concept to restore his missing teeth which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.
CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.	CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.	The patient will be provided with a complete removable denture designed according to the neutral-concept to restore his missing teeth, which will be manufactured by CAD/CAM milling of monolithic methacrylate blanks.

Primary Outcome Measures

Name	Time	Method
Digital Analysis and Comparison of Denture Space Confines for CAD/CAM Dentures Based on the bone-support concept Versus based on the neutral-zone concept Restoring Mandibular Resorbed Ridges using "Medit compare" digital software.	before manufacturing of complete removable denture	comparing the position of the neutral zone to the software-designed anatomical denture confines using "Medit compare" digital software (Medit design, Medit Compare (V1.2), Seoul, South Korea). Average values of facio-lingual deviations between the two dentures in the premolar and molar regions, as well as the anterior region, will be calculated in millimeters, yielding five measurements for each patient's denture sets. Color maps for dimensional deviations of the overall as well as specified surfaces for both dentures revealing the qualitative 3D differences between them will be obtained. Measuring procedures will be similar, as recommended by the manufacturer and all will be performed by the same digital professional operator.

Secondary Outcome Measures

Name	Time	Method
Evaluation of patients' satisfaction with both types of the Complete Removable Dentures	three months	Evaluation of patients' satisfaction with both types of the Complete Removable Dentures by using Patient's Denture Assessment questionnaire (PDA) and interpreting it by using Likert scale (higher score (scale no.5) indicates good outcome and lower score (scale no.1)indicates bad outcome)

Trial Locations

Locations (1)

Faculty of Dentistry, Ain shams University; 🇪🇬 Cairo, Nasr City, Egypt