Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

NCT ID: NCT04701970

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2020-11-12

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

Conditions

Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

relining of mandibular complete denture

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 49 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Research Centre, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Eman Mostafa Ahmed Ibraheem

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Research Centre

Cairo, El- Dokki, Egypt

Countries

Egypt

Other Identifiers

11010203

Identifier Type: -

Identifier Source: org_study_id