Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2020
CompletedFirst Submitted
Initial submission to the registry
November 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 8, 2021
CompletedJanuary 8, 2021
January 1, 2021
5 months
November 23, 2020
January 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
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
Study Arms (1)
changes in the occlusal load distribution
OTHERA 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Research Centre
Cairo, El- Dokki, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 23, 2020
First Posted
January 8, 2021
Study Start
June 1, 2020
Primary Completion
October 20, 2020
Study Completion
November 12, 2020
Last Updated
January 8, 2021
Record last verified: 2021-01