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Completed

NCT Number: NCT05845099

Conventional Versus Digital 3D Printed Complete Removable Dentures

The study is a crossover, randomised, controlled clinical trial that will compare and evaluate patients' satisfaction and oral microbiota proliferation in two groups. Group I: Conventionally manufactured CRD Group II: 3D-printed (three-dimensionally printed) CAD/CAM (computer-aided design/computer-aided manufacturing) manufactured CRD, 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

Conditions

Age range

45 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain shams University

Cairo, 11566, Egypt

About this study

The study will be performed at the outpatient clinic of the Oral and Maxillofacial Prosthodontics Department, Faculty of Dentistry, Ain Shams University. Eleven edentulous male patients will be selected and recruited for this clinical trial after the informed consent provided by Faculty of Dentistry Ain Shams University-Research Ethics Committee (FDASU-REC) is assigned. They will be rehabilitated with Conventional and 3D-printed CAD-CAM (computer-aided design/computer-aided manufacturing) CRD. Participants will be randomly assigned to receive either Conventional or 3D-Printed CAD/CAM-manufactured CRD for three months before crossing over to the other set. care provider , investigator and participants will be blinded to the group allocation. Outcomes will be evaluated, including patient satisfaction with dentures and oral microbial adherence. The outcomes will be measured at baseline and at 1 and 3 months. The obtained data will be recorded, tabulated, and statistically analyzed using the appropriate tests for comparison between each group.

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 at least a year and require treatment with complete dentures.
  • The age of patients ranges from 45 to 60 years old.
  • Patients with a Class I maxillo-mandibular relationship.
  • Patients with adequate inter-arch space.
  • Patients with good neuromuscular control.
  • Patients without any temporomandibular joint 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.
  • Smokers or drug- addicted patients

Treatment and study plan

Polymethyl Methacrylate-Based Complete Removable Dentures.

Device

The patients will receive Complete Removable Dentures processed by Heat cured acrylic resin.

Other names: Complete Removable Denture manufacturing

Photopolymerized Methacrylate- Based Complete Removable Dentures.

Device

The patients will receive a 3D-printed removable denture digitally manufactured using a 3d printer device with light polymerized resin.

Other names: 3D printed Removable Denture manufacturing

Primary outcomes

  1. Assessment of oral microorganism proliferation by talking swab from

    Time frame: 3 months

    Assessment of oral microorganism proliferation by talking swab from the internal surface of both types of CRD to asses the affinity of oral microorganisms.

Secondary outcomes

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

    Time frame: 3 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

Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial

Acronym: CRD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Sep 5, 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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