NCT04701970

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2020

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

5 months

First QC Date

November 23, 2020

Last Update Submit

January 7, 2021

Conditions

Keywords

complete denturesreliningocclusal forceT scan system

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

OTHER

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

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.

changes in the occlusal load distribution

Eligibility Criteria

Age49 Years - 63 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: occlusal load distribution was measured by T scan system before and after mandibular complete denture relining with soft denture liner
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

Locations