Clinical trial NCT06366321: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture
Official title: Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture. Crossover Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Diseases
Dental Trauma
Bone Remodeling Disorder
Keywords: Relining upper denture
Digital denture
Denture Retention
Denture adaptation.
CAD/CAM milling
Lead sponsor: British University In Egypt
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: patient satisfaction using questionnaire
timeFrame: two week
measure: denture retention
timeFrame: two weeks
measure: denture adaptation to oral tissues
timeFrame: at the time of denture insertion
Secondary outcomes:
Other outcomes:
Locations:
city: El Shorouk
country: Egypt
facility: British University in Egypt
state: Cairo
Study officials:
affiliation: British University In Egypt
name: maha kamal, A. Professor
role: PRINCIPAL_INVESTIGATOR
References: