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

NCT ID: NCT05895292

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-04-01

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.

Conditions

Denture, Complete

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

CAD/CAM Milled Methacrylate Complete Removable Dentures based on bone-support concept.

Intervention Type: DEVICE

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 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.

Group Type: ACTIVE_COMPARATOR

CAD/CAM Milled Methacrylate Complete Removable Dentures based on neutral zone concept.

Intervention Type: DEVICE

The patients will receive complete removable dentures designed based on the neutral-zone concept and digitally manufactured using a milling machine

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Omnia M. Refai

Lecturer of Oral and Maxillofacial Prosthodontics,faculty of dentistry , Ain Shams university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Ain shams University

Cairo, Nasr City, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 24876702 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35271758 (View on PubMed)

Other Identifiers

FDASU-RecIR012316

Identifier Type: -

Identifier Source: org_study_id