NCT05895292

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

May 31, 2023

Last Update Submit

September 7, 2024

Conditions

Denture, Complete

Keywords

CAD/CAMDenture, CompletePatient SatisfactionDental Impression Technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation of patients' satisfaction with both types of the Complete Removable Dentures

    three months

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

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

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

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Ain shams University

Cairo, Nasr City, 11566, Egypt

Location

Related 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.

    PMID: 24876702BACKGROUND

  • 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.

    PMID: 35271758BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Twelve patients will be randomly assigned to one of two groups (I or II) by a practitioner who will not be involved in patient selection or treatment but will be aware of the randomization sequence and have access to the randomization lists. This will be stored on a password-protected laptop, and the randomly generated codes will be placed in sequentially ordered, opaque, and sealed envelopes using a research randomizer (https://www.randomizer.org/). Participants were randomized to first receiving either Conventional CAD/CAM manufactured complete removable dentures Based on bone support concept or CAD/CAM neutral zone complete dentures will be designed based on the neutral zone concept and then after 3 months cross over to the other set. Patients and clinical practitioners are blinded to the type of prostheses at all study times.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Oral and Maxillofacial Prosthodontics,faculty of dentistry , Ain Shams university

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 8, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(1)