Status:
UNKNOWN
Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
Lead Sponsor:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
Edentulous Jaw
Periodontitis
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
Loss of masticatory function consequent to tooth loss is associated with changes in food choices and insufficient nutrition intake. To date, studies showed no significant improvement in nutrient intak...
Detailed Description
Complete edentulism or presence of a terminal dentition that is functionally compromised in an irreparable way represent the end of the spectrum of caries and periodontitis, eventually leading to loss...
Eligibility Criteria
Inclusion
- being edentulous or having the presence of terminal dentition (defined as few remaining teeth insufficient in terms of number, position and health status to provide adequate anchorage to a tooth supported or a tooth retained denture) and looking for implant-supported fixed denture treatment
- accepted treatment plan for fixed implant-supported prosthesis restoring at least 10 pairs of occluding teeth
- self-reported inadequate vegetable or fruit or protein intakes (patients were included if at least one of the three criteria listed below were met) I. Patients with a total average daily intake of \< 80 g of poultry, meat and aquatic product. II. Patients with an average daily intake of \< 200 g of fruit. III. Patients with an average daily intake of \< 300 g of vegetables.
- understand written and spoken Chinese and who could respond to Chinese questionnaires
- able and willing to give informed consent for participation in the study
- able and willing to comply with 12-month follow-up
Exclusion
- general contraindications to elective oral surgery procedures
- local contraindications to implant-supported immediate-loading fixed prosthesis (e.g. limited jaw opening, insufficient bone volumes/densities)
- looking for replacement of existing implant-retained overdenture with implant-supported fixed denture treatment
- presence of infectious disease, acute or chronic symptoms of TMJ disorder
- psychiatric disorder, dementia
- any dietary restriction, currently taking nutrient supplements or inability to choose his/her diet.
- uncontrolled diabetes (HbA1c≥7.0%)
- self-reported heavy smokers (\>10 cigarette/day)
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05334407
Start Date
April 18 2022
End Date
December 31 2024
Last Update
November 22 2023
Active Locations (1)
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1
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, China, 201206