Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04701970
• Other study ID #: 11010203
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: November 12, 2020

Study information

• Verified date: January 2021
• Source: National Research Centre, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 12, 2020
• Est. primary completion date: October 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 49 Years to 63 Years

Eligibility

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.

Related Conditions & MeSH terms

• Occlusion

Intervention

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.

Locations

Country	Name	City	State
Egypt	National Research Centre	Cairo	El- Dokki

Sponsors (1)

Lead Sponsor	Collaborator
National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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