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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04701970
Other study ID # 11010203
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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