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Completed

NCT Number: NCT04701970

Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution

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.

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Key information

Age range

49 year–63 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, El- Dokki, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

relining of mandibular complete denture

Procedure

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 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

    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.

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Registry information

Official study title

Effect of Mandibular Complete Dentures Relining on Occlusal Force Distribution Using T- Scan System (A Cross-over Clinical Study)

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 8, 2021
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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