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TOngue/Palate Interactions Study

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
NCT03966131 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The project aims to assess the effect of a complete denture of new denture wearers on speech production using sensors placed inside a duplicate of the prosthesis according to the technique described in the PRESLA system. Secondly, it aims to assess the effect of a complete denture on swallowing for these new denture wearers. Thirdly it aims to describe a precise mapping of the mechanical pressures exerted by the tongue on the palate of complete denture user, been used in wearing denture, during speaking and swallowing. The experiments will take place in the department of treatments and dental consultations of the Hospices Civils de Lyon (Faculty of Odontology, Lyon, France).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Bimaxillary edentulous patients of both genders, over 18 years of age, requiring prosthesis (Cohort 1). * Bimaxillary edentulous patients of both genders, over 18 years of age, with prosthesis made since at least one year (Cohort 2). * Patients Affiliated with the French Social Security Insurance Exclusion Criteria: * Patients with speech or neurological disorders, or uncorrected or psychiatric sensory disorders * Patients without French as native language * Pregnant women * Patients deprived of liberty or provided with legal protection * Patients unable to support study constraints as determined by investigator * Patients who have expressed their refusal to participate with the investigator * Allergy to methacrylic resin
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What it tests

  • Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time)
  • Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)
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Where

1 site
Service de Consultations et de Traitements Dentaires des Hospices Civils de Lyon
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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