Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

Sponsor

National Research Centre, Egypt (Other)

Overall Status

Completed

CT.gov ID

NCT04701970

Collaborator

(none)

Enrollment

Location

Arm

5.4

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Design

Study Type:

Interventional

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 linerocclusal 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 :

Jun 1, 2020

Actual Primary Completion Date :

Oct 20, 2020

Actual Study Completion Date :

Nov 12, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

49 Years to 63 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Research Centre	Cairo	El- Dokki	Egypt

Sponsors and Collaborators

National Research Centre, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eman Mostafa Ahmed Ibraheem, associate professor, National Research Centre, Egypt

ClinicalTrials.gov Identifier:

NCT04701970

Other Study ID Numbers:

11010203

First Posted:

Jan 8, 2021

Last Update Posted:

Jan 8, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Eman Mostafa Ahmed Ibraheem, associate professor, National Research Centre, Egypt

Study Results

No Results Posted as of Jan 8, 2021