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Completed

NCT Number: NCT05895292

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain shams University

Cairo, Nasr City, 11566, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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

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.

    Time frame: 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 outcomes

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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)

Acronym: CAD/CAM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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