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Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects

Primary Purpose

Edentulous Jaw, Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Implant-supported full-arch fixed dental prostheses(dental intervention,DE)
Dietary intervention tailored to the dental status (dietary intervention, DI)
Delayed implant-supported full-arch fixed dental prostheses(dental intervention,DE)
Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw focused on measuring nutrition, implant-supported fixed prosthesis, diet intake, healthy ageing, masticatory function

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Shanghai Perio-Implant Innovation CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

GroupA(DE+/DI+)

GroupB(DE+/DI-)

GroupC(DE-/DI+)

GroupD(DE-/DI-)

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutrient intake
The intake of fruit and vegetables, protein% of total energy according to a modified version of food-frequency questionnaire
Masticatory function
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 oral hygiene
Modified plaque index (mPI) measured by periodontal probing
Peri-implant soft and hard tissue health (probing depth)
Peri-implant probing depth (PD) measured by periodontal probing
Peri-implant soft and hard tissue health (local inflammation)
Peri-implant modified bleeding index (mBI) measured by periodontal probing
Peri-implant radiographic bone level stability
Standardized panoramic radiographic imaging will be conducted to assess the peri-implant bone level.
OHIP-14 questionnaire
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 (i)
blood plasma concentration of homocysteine (gas chromatography)
Metabolism and systemic inflammatory biomarkers (ii)
Plasma hs-CRP assessed by immunoturbidometry
Metabolism and systemic inflammatory biomarkers (iii)
Plasma TNF-α (ELISA)
Metabolism and systemic inflammatory biomarkers (iv)
Plasma IL-1β (ELISA)
Metabolism and systemic inflammatory biomarkers (v)
Plasma IL-6 (ELISA)
Oxidative stress biomarkers (i)
Plasma Co Q10 with liquid chromatography-mass spectrometry
Oxidative stress biomarkers (ii)
Plasma uric acid (the enzymatic method)
Oxidative stress biomarkers (iii)
Plasma superoxide dismutase (the chemical colorimetric method)
Nutritional biomarker(Plasma vitamin A)
concentration of plasma vitamin A assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma vitamin B2)
concentration of plasma vitamin B2 assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma vitamin B12)
concentration of plasma vitamin B12 assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma folate)
concentration of plasma folate assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma vitamin C)
concentration of plasma vitamin C assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma vitamin E)
concentration of plasma vitamin E assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma α-carotene)
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma β-carotene)
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma β-cryptoxanthin)
concentration of plasma β-cryptoxanthin assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma lycopene)
concentration of plasma lycopene assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma lutein/zeaxanthin)
concentration of plasma lutein/zeaxanthin assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma α-tocopherols)
concentration of plasma α-tocopherols assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(plasma γ-tocopherols)
concentration of plasma γ-tocopherols assessed by liquid chromatography-mass spectrometry
Nutritional biomarker(Plasma total cholesterol)
concentration of plasma total cholesterol (Enzymatic Measurements)
Nutritional biomarker(Plasma HDL cholesterol)
concentration of plasma HDL cholesterol (Enzymatic Measurements)
Nutritional biomarker(Plasma LDL cholesterol)
concentration of plasma LDL cholesterol (Enzymatic Measurements)
Nutritional biomarker(Plasma triglycerides)
concentration of plasma triglycerides (Enzymatic Measurements)
Nutritional biomarker(Plasma Lpa)
concentration of plasma Lpa (Enzymatic Measurements)
Metabolomics (Metabolites)
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
Metabolomics (Oxylipidomics)
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
Microbiome Analysis(saliva)
Taxonomic profiling with 16S rRNA gene sequencing in saliva samples
Microbiome Analysis(plaque)
Taxonomic profiling with 16S rRNA gene sequencing in subgingival plaque samples
Microbiome Analysis(stool)
Taxonomic profiling with 16S rRNA gene sequencing in stool samples
Nutritional status
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
Muscle strength
muscle strength assessed by Hand grip dynamometer
Cognitive function(i)
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
Cognitive function(ii)
dementia screening with the Alzheimer's disease eight-item tool. With Score 0: no cognitive impairment, Score 1-2: cognitive impairment; Score>=3: dementia
Depression symptoms
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.

Full Information

First Posted
April 5, 2022
Last Updated
October 25, 2022
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT05334407
Brief Title
Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw, Periodontitis
Keywords
nutrition, implant-supported fixed prosthesis, diet intake, healthy ageing, masticatory function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial design (4 month follow up) and longitudinal follow-up to 12 months
Masking
Care ProviderOutcomes Assessor
Masking Description
Timing of treatment will be concealed to the therapist and to the examiners. All laboratory assessments will be performed blindly.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GroupA(DE+/DI+)
Arm Type
Experimental
Arm Description
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
Arm Title
GroupB(DE+/DI-)
Arm Type
Active Comparator
Arm Description
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
Arm Title
GroupC(DE-/DI+)
Arm Type
Active Comparator
Arm Description
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
Arm Title
GroupD(DE-/DI-)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Implant-supported full-arch fixed dental prostheses(dental intervention,DE)
Other Intervention Name(s)
Immediate rehabilitation of masticatory function
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention tailored to the dental status (dietary intervention, DI)
Other Intervention Name(s)
Immediate dietary intervention
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Delayed implant-supported full-arch fixed dental prostheses(dental intervention,DE)
Other Intervention Name(s)
Delayed rehabilitation of masticatory function
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Delayed dietary intervention tailored to the dental status (dietary intervention, DI)
Other Intervention Name(s)
Delayed dietary intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes in intake of fruit and vegetables
Description
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
Time Frame
from baseline to 4-month
Secondary Outcome Measure Information:
Title
Nutrient intake
Description
The intake of fruit and vegetables, protein% of total energy according to a modified version of food-frequency questionnaire
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Masticatory function
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Peri-implant oral hygiene
Description
Modified plaque index (mPI) measured by periodontal probing
Time Frame
at 4, 8, 12 and 16 months for groups with implants
Title
Peri-implant soft and hard tissue health (probing depth)
Description
Peri-implant probing depth (PD) measured by periodontal probing
Time Frame
at 4, 8, 12 and 16 months for groups with implants
Title
Peri-implant soft and hard tissue health (local inflammation)
Description
Peri-implant modified bleeding index (mBI) measured by periodontal probing
Time Frame
at 4, 8, 12 and 16 months for groups with implants
Title
Peri-implant radiographic bone level stability
Description
Standardized panoramic radiographic imaging will be conducted to assess the peri-implant bone level.
Time Frame
4, and 12 months after dental implant placement (in the context of standard care)
Title
OHIP-14 questionnaire
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolism and systemic inflammatory biomarkers (i)
Description
blood plasma concentration of homocysteine (gas chromatography)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolism and systemic inflammatory biomarkers (ii)
Description
Plasma hs-CRP assessed by immunoturbidometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolism and systemic inflammatory biomarkers (iii)
Description
Plasma TNF-α (ELISA)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolism and systemic inflammatory biomarkers (iv)
Description
Plasma IL-1β (ELISA)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolism and systemic inflammatory biomarkers (v)
Description
Plasma IL-6 (ELISA)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Oxidative stress biomarkers (i)
Description
Plasma Co Q10 with liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Oxidative stress biomarkers (ii)
Description
Plasma uric acid (the enzymatic method)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Oxidative stress biomarkers (iii)
Description
Plasma superoxide dismutase (the chemical colorimetric method)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma vitamin A)
Description
concentration of plasma vitamin A assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma vitamin B2)
Description
concentration of plasma vitamin B2 assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma vitamin B12)
Description
concentration of plasma vitamin B12 assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma folate)
Description
concentration of plasma folate assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma vitamin C)
Description
concentration of plasma vitamin C assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma vitamin E)
Description
concentration of plasma vitamin E assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma α-carotene)
Description
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma β-carotene)
Description
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma β-cryptoxanthin)
Description
concentration of plasma β-cryptoxanthin assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma lycopene)
Description
concentration of plasma lycopene assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma lutein/zeaxanthin)
Description
concentration of plasma lutein/zeaxanthin assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma α-tocopherols)
Description
concentration of plasma α-tocopherols assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(plasma γ-tocopherols)
Description
concentration of plasma γ-tocopherols assessed by liquid chromatography-mass spectrometry
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma total cholesterol)
Description
concentration of plasma total cholesterol (Enzymatic Measurements)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma HDL cholesterol)
Description
concentration of plasma HDL cholesterol (Enzymatic Measurements)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma LDL cholesterol)
Description
concentration of plasma LDL cholesterol (Enzymatic Measurements)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma triglycerides)
Description
concentration of plasma triglycerides (Enzymatic Measurements)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional biomarker(Plasma Lpa)
Description
concentration of plasma Lpa (Enzymatic Measurements)
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolomics (Metabolites)
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Metabolomics (Oxylipidomics)
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Microbiome Analysis(saliva)
Description
Taxonomic profiling with 16S rRNA gene sequencing in saliva samples
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Microbiome Analysis(plaque)
Description
Taxonomic profiling with 16S rRNA gene sequencing in subgingival plaque samples
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Microbiome Analysis(stool)
Description
Taxonomic profiling with 16S rRNA gene sequencing in stool samples
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Nutritional status
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Muscle strength
Description
muscle strength assessed by Hand grip dynamometer
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Cognitive function(i)
Description
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
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Cognitive function(ii)
Description
dementia screening with the Alzheimer's disease eight-item tool. With Score 0: no cognitive impairment, Score 1-2: cognitive impairment; Score>=3: dementia
Time Frame
at baseline, 4, 8, 12 and 16 months
Title
Depression symptoms
Description
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.
Time Frame
at baseline, 4, 8, 12 and 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shujiao Qian, PhD
Phone
15121036374
Email
qianshujiao@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maurizio Tonetti, DMD,PhD
Phone
15000102368
Email
maurizio.tonetti@ergoperio.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Tonetti, DMD,PhD
Organizational Affiliation
Shanghai Perioimplant Innovation Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Perio-Implant Innovation Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201206
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jojo Qian, PhD
Email
qianshujiao@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29926952
Citation
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. Erratum In: J Periodontol. 2018 Dec;89(12):1475.
Results Reference
background
PubMed Identifier
19812868
Citation
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.
Results Reference
result
PubMed Identifier
35239983
Citation
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.
Results Reference
result
PubMed Identifier
20105193
Citation
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.
Results Reference
result
PubMed Identifier
35832045
Citation
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.
Results Reference
derived

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Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects

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