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Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

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ClinicalTrials.gov Identifier: NCT04701970
Recruitment Status : Completed
First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Information provided by (Responsible Party):
Eman Mostafa Ahmed Ibraheem, National Research Centre, Egypt

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.

Condition or disease Intervention/treatment Phase
Occlusion Procedure: relining of mandibular complete denture Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: occlusal load distribution was measured by T scan system before and after mandibular complete denture relining with soft denture liner
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution Using T- Scan System (A Cross-over Clinical Study)
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : October 20, 2020
Actual Study Completion Date : November 12, 2020


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: for each participant: the complete denture should be worn for three months ]

    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.




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Ages Eligible for Study:   49 Years to 63 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701970


Locations
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Egypt
National Research Centre
Cairo, El- Dokki, Egypt
Sponsors and Collaborators
National Research Centre, Egypt
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Responsible Party: Eman Mostafa Ahmed Ibraheem, associate professor, National Research Centre, Egypt
ClinicalTrials.gov Identifier: NCT04701970    
Other Study ID Numbers: 11010203
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Mostafa Ahmed Ibraheem, National Research Centre, Egypt:
complete dentures
relining
occlusal force
T scan system