Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution Using T- Scan System (A Cross-over Clinical Study)

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.

Study Overview

• Status: Completed
• Conditions: Occlusion
• Intervention / Treatment: Procedure: relining of mandibular complete denture

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

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El- Dokki
    • Cairo, El- Dokki, Egypt
      • National Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 49 years to 63 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: changes in the occlusal load distribution; 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. 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

Procedure: relining of mandibular complete denture; Relining of mandibular dentures was performed by reducing one mm of the denture fitting surfaces and borders to make a right-angled border. apply two separate layers of Mucopren adhesive upon the vestibular surface of the mandibular denture and allow each layer to dry for about 40 seconds. then, the lower denture was inserted and molded in patient mouths; while biting in centric occlusion with the opposing maxillary complete dentures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Fifty completey edentulous patients having previously constructed and utilized conventional complete dentures were selected for this study. Relining of mandibular complete dentures with soft denture liner was carried out. Distribution of occlusal force was evaluated with the aid of T-Scan device before denture relining and three months after relining. measured before relining of complete denture with soft liner and measured again after complete denture relining.	for each participant: the complete denture should be worn for three months

Collaborators and Investigators

• Sponsor: National Research Centre, Egypt

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): October 20, 2020
• Study Completion (ACTUAL): November 12, 2020

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (ACTUAL): January 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: complete dentures; relining; occlusal force; T scan system
• Other Study ID Numbers: 11010203

Drug and device information, study documents

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