Edentulous JawNCT05334407
Effect of Implant Treatment and/or Dietary Advice on the Nutrition of Edentulous Ageing Subjects
A study testing Implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Dietary intervention tailored to the dental status (dietary intervention, DI) and Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE） in people with Edentulous Jaw and Periodontitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Edentulous Jaw, Periodontitis
- What is being tested?
- Implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Dietary intervention tailored to the dental status (dietary intervention, DI) and Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Perio-Implant Innovation Center
Shanghai, Shanghai Municipality, 201206
Jojo Qian, PhD, qianshujiao@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Edentulous Jaw, Periodontitis
- Being tested
- 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)
- Keywords
- nutrition, implant-supported fixed prosthesis, diet intake, healthy ageing, masticatory function
- Medical subject headings
- Jaw, Edentulous, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant-supported full-arch fixed dental prostheses（dental intervention,DE）Procedure or surgery
Also called Immediate 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 tailored to the dental status (dietary intervention, DI)Behavioural
Also called Immediate dietary intervention
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）Procedure or surgery
Also called Delayed rehabilitation of masticatory function
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)Behavioural
Also called Delayed dietary intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| GroupA（DE+/DI+） | Experimental | 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 Receives: Procedure: Implant-supported full-arch fixed dental prostheses（dental intervention,DE）; Behavioral: Dietary intervention tailored to the dental status (dietary intervention, DI) |
| GroupB（DE+/DI-） | Active comparator | 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 Receives: Procedure: Implant-supported full-arch fixed dental prostheses（dental intervention,DE）; Behavioral: Delayed dietary intervention tailored to the dental status (dietary intervention, DI) |
| GroupC（DE-/DI+） | Active comparator | 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 Receives: Behavioral: Dietary intervention tailored to the dental status (dietary intervention, DI); Procedure: Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE） |
| GroupD（DE-/DI-） | Placebo comparator | 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. Receives: Procedure: Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）; Behavioral: Delayed dietary intervention tailored to the dental status (dietary intervention, DI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline to 4-month
Secondary outcomes (43)
Nutrient intake
The intake of fruit and vegetables, protein% of total energy according to a modified version of food-frequency questionnaire
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
Peri-implant oral hygiene
Modified plaque index (mPI) measured by periodontal probing
Measured: at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (probing depth)
Peri-implant probing depth (PD) measured by periodontal probing
Measured: at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (local inflammation)
Peri-implant modified bleeding index (mBI) measured by periodontal probing
Measured: at 4, 8, 12 and 16 months for groups with implants
Peri-implant radiographic bone level stability
Standardized panoramic radiographic imaging will be conducted to assess the peri-implant bone level.
Measured: 4, and 12 months after dental implant placement (in the context of standard care)
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
Measured: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (i)
blood plasma concentration of homocysteine (gas chromatography)
Measured: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (ii)
Plasma hs-CRP assessed by immunoturbidometry
Measured: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (iii)
Plasma TNF-α (ELISA)
Measured: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (iv)
Plasma IL-1β (ELISA)
Measured: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (v)
Plasma IL-6 (ELISA)
Measured: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (i)
Plasma Co Q10 with liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (ii)
Plasma uric acid (the enzymatic method)
Measured: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (iii)
Plasma superoxide dismutase (the chemical colorimetric method)
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin A）
concentration of plasma vitamin A assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin B2）
concentration of plasma vitamin B2 assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin B12）
concentration of plasma vitamin B12 assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma folate）
concentration of plasma folate assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin C）
concentration of plasma vitamin C assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin E）
concentration of plasma vitamin E assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma α-carotene）
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma β-carotene）
concentration of plasma α-carotene assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma β-cryptoxanthin）
concentration of plasma β-cryptoxanthin assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma lycopene）
concentration of plasma lycopene assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma lutein/zeaxanthin）
concentration of plasma lutein/zeaxanthin assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma α-tocopherols）
concentration of plasma α-tocopherols assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma γ-tocopherols）
concentration of plasma γ-tocopherols assessed by liquid chromatography-mass spectrometry
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma total cholesterol）
concentration of plasma total cholesterol (Enzymatic Measurements)
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma HDL cholesterol）
concentration of plasma HDL cholesterol (Enzymatic Measurements)
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma LDL cholesterol）
concentration of plasma LDL cholesterol (Enzymatic Measurements)
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma triglycerides）
concentration of plasma triglycerides (Enzymatic Measurements)
Measured: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma Lpa）
concentration of plasma Lpa (Enzymatic Measurements)
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(saliva)
Taxonomic profiling with 16S rRNA gene sequencing in saliva samples
Measured: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(plaque)
Taxonomic profiling with 16S rRNA gene sequencing in subgingival plaque samples
Measured: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(stool)
Taxonomic profiling with 16S rRNA gene sequencing in stool samples
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
Muscle strength
muscle strength assessed by Hand grip dynamometer
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
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
Measured: at baseline, 4, 8, 12 and 16 months
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.
Measured: at baseline, 4, 8, 12 and 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start18 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design (4 month follow up) and longitudinal follow-up to 12 months
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maurizio Tonetti, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Maurizio Tonetti, DMD,PhD, Principal investigator, Shanghai Perioimplant Innovation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334407
- Sponsor's protocol ID
- nutrition2021
- Status last verified
- Nov 2023
- First submitted
- 5 Apr 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29926952Kaiser 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.
PubMed 19812868Deng 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.
PubMed 35239983Ellis 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.
PubMed 20105193Qian 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.
PubMed 35832045
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05334407
- Acronym / sponsor ID
- nutrition2021
- Conditions
- Edentulous Jaw, Periodontitis
- Keywords
- nutrition, implant-supported fixed prosthesis, diet intake, healthy ageing, masticatory function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design (4 month follow up) and longitudinal follow-up to 12 months
| Arm | Type | Receives |
|---|---|---|
| GroupA（DE+/DI+） | Experimental | Procedure: Implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Behavioral: 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-） | Active comparator | Procedure: Implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Behavioral: 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 |
| GroupC（DE-/DI+） | Active comparator | Behavioral: Dietary intervention tailored to the dental status (dietary intervention, DI), Procedure: 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 |
| GroupD（DE-/DI-） | Placebo comparator | Procedure: Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Behavioral: 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implant-supported full-arch fixed dental prostheses（dental intervention,DE）Also: Immediate rehabilitation of masticatory functionImplant-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. | Procedure or surgery | GroupA（DE+/DI+）, GroupB（DE+/DI-） |
| Dietary intervention tailored to the dental status (dietary intervention, DI)Also: Immediate dietary interventionDietary 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. | Behavioural | GroupA（DE+/DI+）, GroupC（DE-/DI+） |
| Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE）Also: Delayed rehabilitation of masticatory functionDelayed (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. | Procedure or surgery | GroupC（DE-/DI+）, GroupD（DE-/DI-） |
| Delayed dietary intervention tailored to the dental status (dietary intervention, DI)Also: Delayed dietary interventionDietary 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. | Behavioural | GroupB（DE+/DI-）, GroupD（DE-/DI-） |
Primary outcome
changes in intake of fruit and vegetables
Time frame: 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
43 secondary outcomes
Nutrient intake
Time frame: at baseline, 4, 8, 12 and 16 months
Masticatory function
Time frame: at baseline, 4, 8, 12 and 16 months
Peri-implant oral hygiene
Time frame: at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (probing depth)
Time frame: at 4, 8, 12 and 16 months for groups with implants
Peri-implant soft and hard tissue health (local inflammation)
Time frame: at 4, 8, 12 and 16 months for groups with implants
Peri-implant radiographic bone level stability
Time frame: 4, and 12 months after dental implant placement (in the context of standard care)
OHIP-14 questionnaire
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (i)
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (ii)
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (iii)
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (iv)
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolism and systemic inflammatory biomarkers (v)
Time frame: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (i)
Time frame: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (ii)
Time frame: at baseline, 4, 8, 12 and 16 months
Oxidative stress biomarkers (iii)
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin A）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin B2）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin B12）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma folate）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin C）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma vitamin E）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma α-carotene）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma β-carotene）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma β-cryptoxanthin）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma lycopene）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma lutein/zeaxanthin）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma α-tocopherols）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（plasma γ-tocopherols）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma total cholesterol）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma HDL cholesterol）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma LDL cholesterol）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma triglycerides）
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional biomarker（Plasma Lpa）
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolomics (Metabolites)
Time frame: at baseline, 4, 8, 12 and 16 months
Metabolomics (Oxylipidomics)
Time frame: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(saliva)
Time frame: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(plaque)
Time frame: at baseline, 4, 8, 12 and 16 months
Microbiome Analysis(stool)
Time frame: at baseline, 4, 8, 12 and 16 months
Nutritional status
Time frame: at baseline, 4, 8, 12 and 16 months
Muscle strength
Time frame: at baseline, 4, 8, 12 and 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 29926952Tonetti 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.
- Results publication: PubMed 19812868Kaiser 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 publication: PubMed 35239983Deng 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 publication: PubMed 20105193Ellis 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.
- Derived from this study: PubMed 35832045Qian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurizio Tonetti, DMD,PhD principal investigator
Shanghai Perioimplant Innovation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant-supported full-arch fixed dental prostheses（dental intervention,DE）, Dietary intervention tailored to the dental status (dietary intervention, DI) and Delayed implant-supported full-arch fixed dental prostheses（dental intervention,DE） in people with Edentulous Jaw and Periodontitis, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shujiao Qian, PhD (15121036374, qianshujiao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in intake of fruit and vegetables (time frame: from baseline to 4-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334407, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.