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

NCT06366321 | Completed

• 1 other identifier: 23-067
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Diseases; Dental Trauma; Bone Remodeling Disorder

Keywords

Relining upper denture; Digital denture; Denture Retention; Denture adaptation.; CAD/CAM milling

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

conventionally constructed denture

OTHER

construction of complete dentures by conventional (lost wax casting) technique

Other: relining technique

digitally constructed denture

OTHER

construction of complete dentures by digital (CAD/CAM milling) technique

Other: CAD/CAM milling technique

Interventions

relining technique OTHER

construction of complete denture by flasking and casting the relining impression

Also known as: no other names

conventionally constructed denture

CAD/CAM milling technique OTHER

construction of complete denture by milling of the scanned relining impression

Also known as: computer added designing/ computer added milling

digitally constructed denture

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

British University in Egypt

El Shorouk, Cairo Governorate, 4914085, Egypt

Location

Related Publications (1)

• Kamal MNM. Comparison between relining of ill-fitted maxillary complete denture versus CAD/CAM milling of new one regarding patient satisfaction, denture retention and adaptation. BMC Oral Health. 2025 Jan 4;25(1):18. doi: 10.1186/s12903-024-05298-z.

  PMID: 39755611 DERIVED

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• maha kamal, A. Professor

  British University In Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 15, 2024
• Study Start: January 1, 2024
• Primary Completion: January 23, 2024
• Study Completion: February 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)