Clinical trial NCT04701970: Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution
Official title: Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution Using T- Scan System (A Cross-over Clinical Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Occlusion
Keywords: complete dentures
relining
occlusal force
T scan system
Lead sponsor: National Research Centre, Egypt
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 50
Sex: MALE
Minimum age (years): 49
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: occlusal load distribution was measured by T scan system before and after mandibular complete denture relining with soft denture liner
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA) for mandibular complete dentures before and after relining with long term soft liner for controlled type 2 diabetic patients.

Detailed description: A crossover clinical study was carried out with previously constructed and used conventional complete dentures before relining with soft denture liners and then with the same dentures after relining with soft denture liners. The study sample included 50 males completely edentulous contributors, All patients were controlled type 2 diabetes during the study period. All selected patients had previously constructed and used conventional heat cured acrylic resin complete dentures for not less than two years with history of retention and stability problems of mandibular dentures. Mandibular complete dentures had received the essential prosthetic adjustments aiming to achieve optimal retention, maximum stability and the necessary occlusal contacts. The first occlusal parameters were recorded before denture relining. Relining of mandibular dentures was performed and Patients were comfortably using their relined mandibular complete dentures for at least three months and the retention and stability of the conventional dentures were assessed before second recording of occlusal parameter. The evaluation of occlusal force distribution was carried out with the aid of T-Scan device (Tekscan Inc., South Boston, MA, USA). The first record was recorded before denture relining and the second record was three months after denture relining

Eligibility criteria: Inclusion Criteria:

* All patients were controlled type 2 diabetes
* All patients were non-smokers
* had an Angle class I maxillo-mandibular relationship.
* Patients having moderately developed maxillary and mandibular alveolar ridges lined with firm mucoperiostea.

Exclusion Criteria:

* history of temporomandibular disorders, or neuromuscular disorders like; bruxism or severe clenching
* presence of medical problems or severe chronic diseases
* any intraoral soft or hard tissue pathology.

Primary outcomes:
measure: assessment of the effect of relining of mandibular complete dentures with soft relining material on occlusal force distribution using T-Scan system. load distribution for 50 completely edentulous patient before and after complete denture relining
timeFrame: for each participant: the complete denture should be worn for three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Research Centre
state: El- Dokki
Study officials:
References: