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

Denture, Complete Clinical Trial

— CAD/CAM  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895292
• Other study ID #: FDASU-RecIR012316
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: January 2024
• Source: Ain Shams University
• Contact: Omnia MS Refai, PHD
• Phone: +201202420046
• Email: omnia_refaie[@]dent.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Denture, Complete

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ain shams University	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Bhorgonde D, Nandakumar K, Khurana PR, Kumari VS, Reddy MS, Siddique S. An evaluation of the position of the neutral zone in relation to the crest of mandibular alveolar ridge - An In-vivo study. J Int Oral Health. 2014 Apr;6(2):45-54. Epub 2014 Apr 26. — View Citation

Choi S, Kim S, Chang JS. The Neutral Zone Approach with CAD-CAM Record Bases. J Prosthodont. 2022 Jul;31(6):459-463. doi: 10.1111/jopr.13502. Epub 2022 Mar 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	before manufacturing of complete removable denture
Secondary	Evaluation of patients' satisfaction with both types of the Complete Removable Dentures	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)	three months