Clinical trial NCT05845099: Conventional Versus Digital 3D Printed Complete Removable Dentures
Official title: Assessment of Microbial Adherence and Patients' Satisfaction in Conventional and Digital 3D Printed Complete Removable Dentures: A Cross Over Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Denture, Complete
Keywords: 3D printing
CAD/CAM
Complete dentures
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 20
Sex: MALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: double blind single center crossover design
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been completely edentulous in both jaws (maxilla and mandible) for at least a year and require treatment with complete dentures.
2. The age of patients ranges from 45 to 60 years old.
3. Patients with a Class I maxillo-mandibular relationship.
4. Patients with adequate inter-arch space.
5. Patients with good neuromuscular control.
6. Patients without any temporomandibular joint 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. Smokers or drug- addicted patients

Primary outcomes:
measure: Assessment of oral microorganism proliferation by talking swab from
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of patients' satisfaction with both types of the Complete Removable Dentures
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Ain shams University
Study officials:
affiliation: lecturer of Oral and Maxillofacial Prosthodontics, Faculty of Dentistry , Ain Shams University
name: Omnia MS Refai, PHD
role: STUDY_CHAIR
affiliation: Lecturer of Oral and Maxillofacial Prosthodontics College of oral and dental surgery Misr University for science and technology
name: Heba RF Elsarrif, PHD
role: STUDY_DIRECTOR
References:
citation: Srinivasan M, Kalberer N, Fankhauser N, Naharro M, Maniewicz S, Muller F. CAD-CAM complete removable dental prostheses: A double-blind, randomized, crossover clinical trial evaluating milled and 3D-printed dentures. J Dent. 2021 Dec;115:103842. doi: 10.1016/j.jdent.2021.103842. Epub 2021 Oct 9.
citation: Baba NZ, AlRumaih HS, Goodacre BJ, Goodacre CJ. Current techniques in CAD/CAM denture fabrication. Gen Dent. 2016 Nov-Dec;64(6):23-28.