Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
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
1 other identifier
interventional
120
1 country
1
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 intake with interventions based solely on dental prostheses. Pilot studies have shown positive impacts of interventions combining implant-supported fixed dental prosthesis with brief dietary interventions. The relative contribution and the potential synergy of the components of such interventions need to be determined as it has major public health implications for the community-dwelling ageing population that continues to disproportionately suffer from tooth loss and its consequences. This study tests the effect of rehabilitation of masticatory function with fixed implant supported dentures and diet re-education on the dietary intake and nutrition in older subjects with terminal dentition (stage IV periodontitis) or full edentulism. A 2 × 2 factorial randomized controlled trial of eligible adult (≥60 years) with loss of masticatory function consequent to full arch edentulism or terminal dentition (n = 120) will be conducted to test whether the rehabilitation of masticatory function with fixed implant supported dentures, diet re-education and/or their combination improves the diet and nutrition of ageing subjects. The study has been designed to detect changes in fruit and vegetable intake at 4 months using the 24-hour dietary recall method. Changes in protein as percentage of total energy, nutritional biomarkers, metabolomics, oral and gut microbiome, quality of life and masticatory function will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2022
CompletedStudy Start
First participant enrolled
April 18, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedNovember 22, 2023
November 1, 2023
2 years
April 5, 2022
November 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in intake of fruit and vegetables
Three 24-hour dietary recall will be conducted through interview, twice on weekdays and once on weekend. The data on food consumption will be converted into the corresponding nutrient contents based on the China Food Composition Tables Standard Edition
from baseline to 4-month
Secondary Outcomes (43)
Nutrient intake
at baseline, 4, 8, 12 and 16 months
Masticatory function
at baseline, 4, 8, 12 and 16 months
Peri-implant oral hygiene
at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (probing depth)
at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (local inflammation)
at 4, 8, 12 and 16 months for groups with implants
- +38 more secondary outcomes
Study Arms (4)
GroupA（DE+/DI+）
EXPERIMENTALThe treatment includes the combination of implant-supported full-arch fixed prostheses (dental intervention, DE) and dietary intervention tailored to the dental status (dietary intervention, DI) without waiting period
GroupB（DE+/DI-）
ACTIVE COMPARATORThe treatment includes implant-supported full-arch fixed prostheses (dental intervention, DE) without waiting period and dietary intervention tailored to the dental status (dietary intervention, DI) 4-month later
GroupC（DE-/DI+）
ACTIVE COMPARATORThe treatment includes dietary intervention tailored to the dental status (dietary intervention, DI) without waiting period and implant-supported full-arch fixed prostheses (dental intervention, DE) 4-month later
GroupD（DE-/DI-）
PLACEBO COMPARATORThe treatment included implant-supported full-arch fixed prostheses (dental intervention, DE) and dietary intervention tailored to the dental status (dietary intervention, DI) with 4-month waiting period. Only general dietary information is provided at baseline.
Interventions
Delayed (4 months) implant-supported full-arch fixed dental prostheses in at least one jaw and appropriate treatment in the opposing jaw regarding periodontal diseases, caries, replacement of missing teeth and soft tissue disorders to get at least 10 pairs of occluding teeth. The intervention is designed to provide rehabilitation of masticatory function.
Implant-supported full-arch fixed dental prostheses in at least one jaw and appropriate treatment in the opposing jaw regarding periodontal diseases, caries, replacement of missing teeth and soft tissue disorders to get at least 10 pairs of occluding teeth. The intervention is designed to provide rehabilitation of masticatory function.
Dietary intervention based on the health Belief Model (HBM) with the behavioral goal of increasing an individual's likelihood of food intake regarding fresh vegetables, fresh fruits, and high quality protein for the potential intervention strategies. Participants will receive 20 minutes' coordinated dietary advice in the form of the slideshow presentation . A pamphlet prepared with reference to the Supplementary Guidelines for Elderly Populations, the 4th edition of the Dietary Guidelines for Chinese will be given to the participant separately. If a participant does not prepare his or her own meals, the person who does the cooking receives the dietary advice as well.
Dietary intervention based on the health Belief Model (HBM) with the behavioral goal of increasing an individual's likelihood of food intake regarding fresh vegetables, fresh fruits, and high quality protein for the potential intervention strategies. Participants will receive 20 minutes' coordinated dietary advice in the form of the slideshow presentation . A pamphlet prepared with reference to the Supplementary Guidelines for Elderly Populations, the 4th edition of the Dietary Guidelines for Chinese will be given to the participant separately. If a participant does not prepare his or her own meals, the person who does the cooking receives the dietary advice as well.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, 201206, China
Related Publications (5)
Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PMID: 29926952BACKGROUNDKaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.
PMID: 19812868RESULTDeng K, Uy SNMR, Fok C, Fok MR, Pelekos G, Tonetti MS. Assessment of masticatory function in the differential diagnosis of Stage IV periodontitis: A pilot diagnostic accuracy study. J Periodontol. 2022 Jun;93(6):803-813. doi: 10.1002/JPER.21-0660. Epub 2022 Mar 24.
PMID: 35239983RESULTEllis JS, Elfeky AF, Moynihan PJ, Seal C, Hyland RM, Thomason M. The impact of dietary advice on edentulous adults' denture satisfaction and oral health-related quality of life 6 months after intervention. Clin Oral Implants Res. 2010 Apr 1;21(4):386-91. doi: 10.1111/j.1600-0501.2009.01859.x. Epub 2010 Jan 22.
PMID: 20105193RESULTQian SJ, Liu B, Shi J, Zhang X, Deng K, Shen J, Tao Y, Qiao S, Lai HC, Yuan C, Tonetti MS. Effects of Dental Implants and Nutrition on Elderly Edentulous Subjects: Protocol for a Factorial Randomized Clinical Trial. Front Nutr. 2022 Jun 27;9:930023. doi: 10.3389/fnut.2022.930023. eCollection 2022.
PMID: 35832045DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maurizio Tonetti, DMD,PhD
Shanghai Perioimplant Innovation Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Masking Details
- Timing of treatment will be concealed to the therapist and to the examiners. All laboratory assessments will be performed blindly.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Shanghai Perioimplant Innovation Center，Professor of Shanghai Jiao Tong University School of Medicine, chairman of expert Committee of National Clinical Research Center.
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 19, 2022
Study Start
April 18, 2022
Primary Completion
April 30, 2024
Study Completion
December 31, 2024
Last Updated
November 22, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share