Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
- Conditions
- Edentulous JawPeriodontitis
- Interventions
- Procedure: Implant-supported full-arch fixed dental prostheses（dental intervention,DE）Behavioral: Dietary intervention tailored to the dental status (dietary intervention, DI)Procedure: Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）Behavioral: Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
- Registration Number
- NCT05334407
- Lead Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- 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.
- 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 of masticatory function. These subjects tend to show change in their diet behavior choosing softer diets with higher carbohydrates and fat and less fresh fruit and vegetables.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description GroupA（DE+/DI+） Implant-supported full-arch fixed dental prostheses（dental intervention,DE） 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 GroupC（DE-/DI+） Dietary intervention tailored to the dental status (dietary intervention, 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 GroupC（DE-/DI+） Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE） 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 GroupB（DE+/DI-） Delayed dietary intervention tailored to the dental status (dietary intervention, 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 GroupD（DE-/DI-） Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE） 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. GroupA（DE+/DI+） Dietary intervention tailored to the dental status (dietary intervention, 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 GroupB（DE+/DI-） Implant-supported full-arch fixed dental prostheses（dental intervention,DE） 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 GroupD（DE-/DI-） Delayed dietary intervention tailored to the dental status (dietary intervention, 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.
- Primary Outcome Measures
Name Time Method changes in intake of fruit and vegetables from baseline to 4-month 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
- Secondary Outcome Measures
Name Time Method Peri-implant oral hygiene at 4, 8, 12 and 16 months for groups with implants Modified plaque index (mPI) measured by periodontal probing
Peri-implant soft and hard tissue health (local inflammation) at 4, 8, 12 and 16 months for groups with implants Peri-implant modified bleeding index (mBI) measured by periodontal probing
Nutritional biomarker（Plasma LDL cholesterol） at baseline, 4, 8, 12 and 16 months concentration of plasma LDL cholesterol (Enzymatic Measurements)
Microbiome Analysis(stool) at baseline, 4, 8, 12 and 16 months Taxonomic profiling with 16S rRNA gene sequencing in stool samples
Nutritional status at baseline, 4, 8, 12 and 16 months assessment by Mini-nutrient status form with a score of 12-14 corresponding to normal nutritional status；8-11 at risk of malnutrition；0-7 malnourished
OHIP-14 questionnaire at baseline, 4, 8, 12 and 16 months the impact of oral health on the quality of life of participants assessed with the oral health impact profile (OHIP)-14. A 5-point scale was used to calculate the score for each of 14 items. The total score of OHIP-14 is in the range of 0 to 56 with higher values indicating more frequent impacts
Metabolism and systemic inflammatory biomarkers (iii) at baseline, 4, 8, 12 and 16 months Plasma TNF-α (ELISA)
Metabolism and systemic inflammatory biomarkers (v) at baseline, 4, 8, 12 and 16 months Plasma IL-6 (ELISA)
Nutritional biomarker（Plasma Lpa） at baseline, 4, 8, 12 and 16 months concentration of plasma Lpa (Enzymatic Measurements)
Metabolomics (Oxylipidomics) at baseline, 4, 8, 12 and 16 months Profiling of annotated plasma lipid metabolites (Differential lipid metabolites with P-value\< 0.05 and fold change≥2 or FC≤0.5) based on untargeted metabolomics using liquid chromatography coupled with mass spectrometry analyses
Nutrient intake at baseline, 4, 8, 12 and 16 months The intake of fruit and vegetables, protein% of total energy according to a modified version of food-frequency questionnaire
Nutritional biomarker（Plasma vitamin B2） at baseline, 4, 8, 12 and 16 months concentration of plasma vitamin B2 assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（Plasma vitamin C） at baseline, 4, 8, 12 and 16 months concentration of plasma vitamin C assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（Plasma vitamin E） at baseline, 4, 8, 12 and 16 months concentration of plasma vitamin E assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（Plasma HDL cholesterol） at baseline, 4, 8, 12 and 16 months concentration of plasma HDL cholesterol (Enzymatic Measurements)
Muscle strength at baseline, 4, 8, 12 and 16 months muscle strength assessed by Hand grip dynamometer
Peri-implant radiographic bone level stability 4, and 12 months after dental implant placement (in the context of standard care) Standardized panoramic radiographic imaging will be conducted to assess the peri-implant bone level.
Metabolism and systemic inflammatory biomarkers (i) at baseline, 4, 8, 12 and 16 months blood plasma concentration of homocysteine (gas chromatography)
Oxidative stress biomarkers (i) at baseline, 4, 8, 12 and 16 months Plasma Co Q10 with liquid chromatography-mass spectrometry
Oxidative stress biomarkers (ii) at baseline, 4, 8, 12 and 16 months Plasma uric acid (the enzymatic method)
Oxidative stress biomarkers (iii) at baseline, 4, 8, 12 and 16 months Plasma superoxide dismutase (the chemical colorimetric method)
Nutritional biomarker（Plasma folate） at baseline, 4, 8, 12 and 16 months concentration of plasma folate assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma lutein/zeaxanthin） at baseline, 4, 8, 12 and 16 months concentration of plasma lutein/zeaxanthin assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma α-tocopherols） at baseline, 4, 8, 12 and 16 months concentration of plasma α-tocopherols assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（Plasma total cholesterol） at baseline, 4, 8, 12 and 16 months concentration of plasma total cholesterol (Enzymatic Measurements)
Nutritional biomarker（Plasma triglycerides） at baseline, 4, 8, 12 and 16 months concentration of plasma triglycerides (Enzymatic Measurements)
Microbiome Analysis(saliva) at baseline, 4, 8, 12 and 16 months Taxonomic profiling with 16S rRNA gene sequencing in saliva samples
Microbiome Analysis(plaque) at baseline, 4, 8, 12 and 16 months Taxonomic profiling with 16S rRNA gene sequencing in subgingival plaque samples
Cognitive function(ii) at baseline, 4, 8, 12 and 16 months dementia screening with the Alzheimer's disease eight-item tool. With Score 0: no cognitive impairment, Score 1-2: cognitive impairment; Score\>=3: dementia
Cognitive function(i) at baseline, 4, 8, 12 and 16 months cognitive function assessed with the Mini-Mental State Examination with a total score of 30. Score 27-30: normal cognition；Score 21-26: mild cognitive impairment；Score 10-20: moderate cognitive impairment；Score \<10: severe cognitive impairment
Nutritional biomarker（Plasma vitamin B12） at baseline, 4, 8, 12 and 16 months concentration of plasma vitamin B12 assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma lycopene） at baseline, 4, 8, 12 and 16 months concentration of plasma lycopene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma γ-tocopherols） at baseline, 4, 8, 12 and 16 months concentration of plasma γ-tocopherols assessed by liquid chromatography-mass spectrometry
Metabolomics (Metabolites) at baseline, 4, 8, 12 and 16 months Profiling of annotated plasma metabolites (Differential plasma metabolites with P-value\< 0.05 and fold change≥2 or FC≤0.5) based on untargeted metabolomics using liquid chromatography coupled with mass spectrometry analyses
Depression symptoms at baseline, 4, 8, 12 and 16 months assessment with the shortened Center for Epidemiologic Studies Depression Scale. The total score is the sum of 10 items. A score equal to or above 10 is considered depressed.
Masticatory function at baseline, 4, 8, 12 and 16 months Ability to mix a two-color chewing gum with 20 masticatory cycles. The obtained bolus will be pressed to a standardized height and a color image will be acquired. Quantitative data will be obtained by digital analysis of the image using variance of hue as the outcome
Peri-implant soft and hard tissue health (probing depth) at 4, 8, 12 and 16 months for groups with implants Peri-implant probing depth (PD) measured by periodontal probing
Metabolism and systemic inflammatory biomarkers (ii) at baseline, 4, 8, 12 and 16 months Plasma hs-CRP assessed by immunoturbidometry
Metabolism and systemic inflammatory biomarkers (iv) at baseline, 4, 8, 12 and 16 months Plasma IL-1β (ELISA)
Nutritional biomarker（Plasma vitamin A） at baseline, 4, 8, 12 and 16 months concentration of plasma vitamin A assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma α-carotene） at baseline, 4, 8, 12 and 16 months concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma β-carotene） at baseline, 4, 8, 12 and 16 months concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker（plasma β-cryptoxanthin） at baseline, 4, 8, 12 and 16 months concentration of plasma β-cryptoxanthin assessed by liquid chromatography-mass spectrometry
Trial Locations
- Locations (1)
Shanghai Perio-Implant Innovation Center
🇨🇳Shanghai, Shanghai, China