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NCT Number: NCT06366321

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

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.

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Key information

Conditions

Dental Diseases Bone Remodeling Disorder Dental Trauma Stomatognathic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British University in Egypt

El Shorouk, Cairo Governorate, 4914085, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

relining technique

Other

construction of complete denture by flasking and casting the relining impression

Other names: no other names

CAD/CAM milling technique

Other

construction of complete denture by milling of the scanned relining impression

Other names: computer added designing/ computer added milling

Primary outcomes

  1. patient satisfaction using questionnaire

    Time frame: two week

    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.

  2. denture retention

    Time frame: two weeks

    • 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.

  3. denture adaptation to oral tissues

    Time frame: at the time of denture insertion

    • 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.

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Apr 16, 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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