TOngue/Palate Interactions Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time): Tongue pressure recordings during speech production, wet and dry swallowing tasks planned in 3 sessions, when the complete denture is worn for the first time, after 3 weeks, then after 3 months in order to characterise the adaptation to this new prosthesis.

Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture): These measures provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during speech production in patients used to their prosthesis. They also provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during swallowing) in these patients. The measurement is made at once when the new denture which replaces the old one is placed in the mouth.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Change from Baseline Pressure signal (time and amplitude) at week 3 and month 3, during speech production for new denture wearers using duplicate with up to 8 sensors — Day 0 (Baseline), Week 3 and Month 3
  The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.
• Change from Baseline Pressure signal Acoustic signal (time and frequence) at week 3 and month 3, during speech production for new denture wearers using duplicate with up to 8 sensors — Day 0 (Baseline), Week 3 and Month 3
  The evaluation of speech production is based on the characteristics of the pressure and acoustic signals after synchronization during time, using duplicate with up to 8 sensors.

Trial sites (1)

More Hospices Civils de Lyon trials in France