Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
NCT ID: NCT05334407
Last Updated: 2023-11-22
Study Results
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Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-04-18
2024-12-31
Brief Summary
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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.
Detailed Description
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Accumulating evidence points to the presence of an association between changes in dietary behavior consequent to tooth loss and insufficient nutrition intake. Such impaired nutrition may have long term effects on muscle strength and physical decline, and be detrimental to general health. Indeed, the recent GBD study of dietary risk factors identifies 15 important disease associated exposures. Their analysis shows that 5 of the health associated exposures: consumption of fruit, vegetables, whole grains, nuts, and fiber require a good level of mastication.
While the physiology of mastication is an essential component of alimentation and contributes to the broader process of nutrition, a more holistic approach is needed to properly establish the scientific basis of the contribution of oral health to nutrition and healthy ageing. Assuming a potential cause-effect relationship between the inadequate food choice consequent to tooth loss and compromised nutrition intake, several studies have tried to improve the nutrient intake among edentulous individuals with various types of dentures. However, this goal has not been readily achieved with either complete denture or implant-retained overdenture, given the function limitation on these prosthesis and the lack of dietary intervention.
A small-scale case series has shown that implant-supported fixed prosthesis resulted in more efficient mastication and improved nutrient intake compared with conventional and implant-based removable dentures in partial edentulism. However, no evidence is available regarding the effect of re-establishment of masticatory function with an implant-supported fixed prosthesis in edentulous patients.
Moreover, with the increasing evidence suggesting a positive impact of nutrition counselling on the dietary intake, brief dietary advice has been advocated to help patients make full use of the enhanced masticatory function to improve their diet. Ellis et al. further showed that the impact of dietary advice on patient's satisfaction with dentures and oral health-related quality of life depends on the nature of the prosthesis. No trial has been performed to assess the benefit of dietary advice only or the combined effect of re-establishment of masticatory function with an implant-supported fixed prosthesis and dietary advice in edentulous elderly subjects.
This is a 2 × 2 factorial clinical trial aimed to assess the effect of rehabilitation of masticatory function with fixed implant supported dentures and simultaneous diet re-education on the diet intake and nutrition in ageing subjects with terminal dentition (stage IV periodontitis) or full edentulism.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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GroupA（DE+/DI+）
The 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
Implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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 tailored to the dental status (dietary intervention, DI)
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.
GroupB（DE+/DI-）
The 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
Implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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.
Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
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.
GroupC（DE-/DI+）
The 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
Dietary intervention tailored to the dental status (dietary intervention, DI)
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.
Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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.
GroupD（DE-/DI-）
The 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.
Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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.
Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
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.
Interventions
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Implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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 tailored to the dental status (dietary intervention, DI)
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.
Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）
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.
Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
ALL
No
Sponsors
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Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
OTHER
Responsible Party
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Maurizio Tonetti
Director of Shanghai Perioimplant Innovation Center，Professor of Shanghai Jiao Tong University School of Medicine, chairman of expert Committee of National Clinical Research Center.
Principal Investigators
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Maurizio Tonetti, DMD,PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Perioimplant Innovation Center
Locations
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Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Kaiser 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.
Deng 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.
Ellis 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.
Qian 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.
Other Identifiers
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nutrition2021
Identifier Type: -
Identifier Source: org_study_id