Impact of dental implants and dietary advice on nutrition in older adults without teeth
Does the Rehabilitation of Masticatory Function and/or Brief Dietary Advice Improve the Diet and Nutrition of Older Subjects With Terminal Dentition or Full Edentulism? A Factorial Randomized Controlled Clinical Trial
This study is testing if getting dental implants and receiving dietary advice can help older adults without teeth improve their nutrition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05334407 on ClinicalTrials.gov |
What this trial studies
This study investigates how implant-supported dentures combined with dietary education can improve nutrition in older adults who are edentulous or have terminal dentition. It employs a 2 × 2 factorial randomized controlled trial design to assess the effects of these interventions on dietary intake and overall nutrition. The research aims to address the link between tooth loss, dietary changes, and insufficient nutrition, which can lead to broader health issues in the aging population. By exploring the synergy between dental rehabilitation and dietary advice, the study seeks to provide evidence for better nutritional outcomes in this demographic.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults who are edentulous or have terminal dentition and are seeking treatment with implant-supported fixed dentures.
Not a fit: Patients who have sufficient remaining teeth to support a denture or those who do not report inadequate dietary intake may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the nutritional intake and overall health of older adults suffering from tooth loss.
How similar studies have performed: Previous pilot studies have shown positive impacts of combining dental prostheses with dietary interventions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Shanghai, Shanghai
- Shanghai Perio-Implant Innovation Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Maurizio Tonetti, DMD,PhD — Shanghai Perioimplant Innovation Center
- Study coordinator: Shujiao Qian, PhD
- Email: qianshujiao@gmail.com
- Phone: 15121036374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.