Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture

Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture. Crossover Randomized Control Trial.

This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues.

Study Overview

• Status: Completed
• Conditions: Dental Trauma; Dental Diseases; Bone Remodeling Disorder
• Intervention / Treatment: Other: relining technique; Other: CAD/CAM milling technique

Detailed Description

Twelve edentulous patients suffering from loose maxillary complete dentures were selected, the dentures were adjusted for taking the relining impressions, the impressions were scanned and the STL files were used for milling new dentures (Group A), then the relining impression went through the conventional laboratory steps of processing (Group B). Both groups were evaluated regarding patient's satisfaction by a specially designed questionnaire, retention values were measured by a digital force gauge at denture insertion appointment and two weeks later, finally dentures adaptation to the oral tissues were compared using geomagic software.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • El Shorouk, Cairo, Egypt, 4914085
      • British University In Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with completely edentulous maxillary and mandibular ridges with a normal skeletal relationship (class I) have a moderate-to-highly well-rounded maxillary edentulous ridge without severe undercuts to minimize the effect of undercuts on retention values.
• Patients' main complaint was a loose or "falling" denture, but with proper esthetics, centric relation and the correct vertical dimension of occlusion (VDO).

Exclusion Criteria:

• Patients with significant skeletal problems (class II or III) or who went through severe osseous surgery or any hereditary or acquired osseous abnormality find it challenging to place the denture properly on the supporting ridge.
• If the patient suffers from xerostomia, excessive flabby ridges, any pathology of the oral mucosa, or any inflammatory changes, candidiasis, hyperplasia, neurological disorders and malignancies
• If the denture creates a major speech problem, poor esthetics, or an unsatisfactory jaw relationship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: conventionally constructed denture; construction of complete dentures by conventional (lost wax casting) technique	Other: relining technique; construction of complete denture by flasking and casting the relining impression; Other Names: no other names
Other: digitally constructed denture; construction of complete dentures by digital (CAD/CAM milling) technique	Other: CAD/CAM milling technique; construction of complete denture by milling of the scanned relining impression; Other Names: computer added designing/ computer added milling

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction using questionnaire	A version of Likert scale with ranges from 1 (completely unsatisfied) to 5 (completely satisfied) was used representing the denture satisfaction scale at denture insertion time and two weeks later regarding denture retention, improved mastication, proper speech, and esthetics. Patient-based outcomes data were collected. A total satisfaction score was calculated of each item; higher scores mean greater satisfaction.	two week
denture retention	An (19-gauge) orthodontic wire in the form of a hook was secured on the center of the palate at a point of intersection of the lines connecting the hamular notches, the right and left canines with the midline by self-cured acrylic resin material and placed on the supporting tissues intraorally.; Testing procedure: The patient was in an upright position. Digital force gauge (Force Gauge HF- 50N) was linked to the hook and a downward pulled force was applied slowly in a vertical direction opposite to that of the denture path of insertion until the denture was displaced and the highest force value was registered. After completing this procedure three times, the average was determined.	two weeks
denture adaptation to oral tissues	Maxillary arches of all patients were scanned using intraoral scanner (3 shape TRIOS 4 wired, Copenhagen, Denmark), fitting surfaces of both denture groups were also scanned using desktop scanner ( 3Shape E2, Copenhagen, Denmark) then A 3D measurement program (Geomagic Control X, 3D Systems, United States) was used to build and superimpose STL files using first initial alignment and then best-fit alignment (fig 7 A&B). For every measurement point, the root mean square (RMS) (mm) was computed considering both positive and negative values.; Color map of CAD/CAM milled denture's fitting surface adaptation and of conventionally relined denture's fitting surface adaptation was formed, pressure from the denture fitting surface to the oral tissues is indicated by yellow to red colors. The denture fitting surface and oral tissues are separated by a blue color. Green color denotes that the oral tissues and the denture fitting surface are in contact.	at the time of denture insertion

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Principal Investigator: maha kamal, A. Professor, British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Denture Retention; Digital denture; Relining upper denture; Denture adaptation.; CAD/CAM milling
• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: 23-067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No