Nutritional Intervention for Older Adults With Complete Dentures

Official title

Novel Dietary Guidelines for Elderly Denture-wearers to Ensure Adequate Nutritional Intake, Good Quality of Life and Enhanced Performance on Cognitive Tasks

Overview

The purpose of this clinical trial is to test a nutritional intervention. This study helps older adults who wear complete removable dentures improve their health. The main questions the study aims to answer are: * What are the participants life experiences living with complete dentures before the intervention? * Does the intervention improve the diet quality of the participants? * Does the intervention improve nutritional status of the participants? * Does the intervention improve chewing performance and muscle strength? * Does the intervention increase the thickness of the masticatory muscles? * Does the intervention improve stress and muscle health markers in saliva? * Does the intervention improve cognitive performance and oral health-related quality of life? * Does the intervention improve cerebral blood flow? The study will include a total of 40 participants, who will be assigned to two groups. One group of 20 participants will receive the nutritional intervention, while the other group of 20 participants will maintain their usual diet during the study period. This comparison will allow the investigators to assess the effectiveness of the intervention. Participants will: * Take part in a personal interview about their life experience with dentures. * Follow a dietary guide with recommendations on specific food textures for six months. * Receive personalized nutritional counseling and participate in healthy cooking workshops. * Use a custom-built mobile application to access the educational content of the nutritional guide, view instructional videos uploaded biweekly, and receive automated reminder notifications. * Attend clinical follow-up assessments, including chewing performance, muscle assessment, saliva markers, assessment of diet quality and nutritional status, cognitive tests, and oral health-related quality of life. * Complete these assessments at three main time points: baseline, 3 months, and 6 months.

Detailed description

This clinical trial evaluates the effectiveness of a multidimensional nutritional intervention on the functional, physiological, and cognitive health of older adults wearing complete removable dentures. The study employs a convergent parallel mixed-methods design to integrate quantitative with qualitative outcomes.

1. Methodological Evaluation Protocols

Participants will undergo comprehensive clinical and laboratory assessments: * Masticatory Function and Muscle Health: Chewing kinematics will be evaluated using 3D electromagnetic articulography (3D-EMA). Maximum bite force will be measured with a digital gnatodynamometer. Masticatory performance will be determined through a standardized peanut-sieving method. Additionally, masseter and temporalis muscle thickness will be assessed via ultrasonography. * Salivary Biomarkers: Saliva samples will be collected to quantify markers of physiological stress and muscle health: Cortisol, Insulin-like Growth Factor 1 (IGF-1), and Creatine Kinase (CK). Oxidative stress and antioxidant capacity will be analyzed using ROS, DPPH, and ORAC parameters. * Baseline Sociodemographic Characteristics: Sociodemographic characteristics will be collected at baseline using a structured questionnaire. The questionnaire will include information on age, sex, educational level, marital status, occupation or employment status, income level, and other relevant background variables. * Nutritional Status Assessment: Nutritional status will be monitored monthly through anthropometric measurements and body composition assessment. These include weight, height, body mass index (BMI), waist circumference, and body fat percentage determined by bioelectrical impedance analysis (BIA). * Cognitive Performance and Cerebral Blood Flow: Cognitive tasks will be evaluated using the Addenbrooke's Cognitive Examination-Revised (ACE-R) and a digital Stroop test to measure attention and executive function. Additionally, transcranial Doppler ultrasonography will be used to monitor cerebral blood flow. * Qualitative Dimension: Individual semi-structured interviews based on Grounded Theory will explore participants' life experiences regarding tooth loss, denture adaptation, and psychosocial barriers before and after the intervention. 2. Intervention Logistics and Groups

The 40 participants will be randomly allocated into two balanced groups (20 participants per arm):

* Intervention Group: Participants will receive a 6-month educational nutritional intervention. This will include in-person nutritional counseling before starting the intervention, and again during the 3rd and 6th months. In addition, telephone nutritional counseling will be provided during the 4th and 5th months. All counseling sessions will be delivered by a trained nutritionist. During the first nutritional counseling session, participants will receive a dietary guideline booklet for users of removable dentures. This guide was developed based on the results of the first stage of the project and promotes foods that support chewing function, as well as adherence to a Chilean-adapted Mediterranean diet. The guideline will also include healthy recipes. During the 2nd month of the study, participants will be invited to attend a practical workshop led by a nutritionist and a chef, where they will prepare recipes included in the dietary guide. All participants in the intervention group will receive a monthly food box containing non-perishable components of the diet. This intervention is complemented by a custom-developed mobile application tailored to meet the study's requirements. Through this app, participants can access the full nutritional guide in PDF format, view new educational and instructional videos uploaded biweekly, and receive automated push notifications as reminders to enhance usability and compliance. * Control Group: Participants will maintain their usual diet for 6 months and undergo the same follow-up assessments as the intervention group. To ensure ethical equity, at the end of the intervention, all participants in the control group will receive one food box, the dietary guideline for users of removable dentures, access to the mobile application, and will be invited to attend a practical workshop led by a nutritionist and a chef.

Interventions

• Behavioral Nutritional Intervention
  This 6-month nutritional intervention for older adults wearing complete removable dentures consists of 6 components: 1. In-person nutritional consultation: A trained nutritionist will provide dietary guidance, adapt recommendations to individual needs and support the initiation of dietary changes. 2. Telephone follow-up: Monthly counseling sessions to monitor progress, address question and reinforce adherence to the intervention. 3. Dietary guidelines booklet: Includes specific nutritional reco

Primary outcome measures

• Masticatory Performance [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Diet Quality Assessment [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Perceptions of Edentulism and Adaptation to Complete Removable Dentures [Time frame: Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias).]

Secondary outcome measures (12)

• Masticatory Kinematics: Number of Chewing Cycles [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Masticatory Kinematics: Chewing Cycle Area [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Masticatory Kinematics: Masticatory Frequency [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Masticatory Kinematics: Masticatory Speed [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Maximum Bite Force [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]
• Masticatory Muscles Thickness [Time frame: T0 (month 0) and T2 (month 6).]
• Salivary Biomarkers: Cortisol [Time frame: T0 (month 0) and T2 (month 6).]
• Salivary Biomarkers: Insulin-like Growth Factor 1 (IGF-1) [Time frame: T0 (month 0) and T2 (month 6).]
• Salivary Biomarkers: Creatine Kinase (CK) [Time frame: T0 (month 0) and T2 (month 6).]
• Salivary Biomarkers: General Oxidative Stress (ROS) [Time frame: T0 (month 0) and T2 (month 6).]
• Salivary Biomarkers: Total Antioxidant Capacity (TAC) [Time frame: T0 (month 0) and T2 (month 6).]
• Oral Health-Related Quality of Life [Time frame: T0 (month 0), T1 (month 3) and T2 (month 6).]

Eligibility criteria

Inclusion criteria

• Men and women aged 60 to 80 years.
• Systemically healthy individuals or those with controlled chronic systemic conditions under regular medical supervision.
• Functionally independent individuals, or those with a dedicated family member or caregiver available to provide support throughout the study period.
• Wearers of both maxillary and mandibular complete removable dentures.
• Adequate stability, retention, and functionality of both complete dentures allowing the participant to chew effectively during daily meals (accepting minor retention or stability limitations in the mandibular prosthesis, provided routine functional mastication is maintained).
• Acceptable centric occlusion and jaw relationship allowing functional mastication.
• Intact oral mucosa without active lesions or severe soreness in the denture-bearing areas.

Exclusion criteria

• Altered salivary flow (hyposalivation or xerostomia) identified via anamnesis and sialometry, with an unstimulated salivary flow rate < 0.1 mL/min or a stimulated salivary flow rate < 0.5 mL/min.
• Active oral mucosa diseases or lesions (e.g., cheilitis, denture stomatitis, ulcers, or aphthae) verified through intraoral examination.
• Diagnosis of a major neurocognitive disorder by a qualified professional, verified via medical records and/or caregiver interview.
• Color blindness (daltonism or color vision deficiency).
• Presence of signs or symptoms of temporomandibular disorders (TMD).
• Known history of allergy to peanuts or latex.
• Underweight or severe undernutrition, defined as a Body Mass Index (BMI) < 18.5 kg/m².

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Chile · 1 center

• Universidad de La Frontera — Temuco

Publications

• Echeverria G, Urquiaga I, Concha MJ, Dussaillant C, Villarroel L, Velasco N, Leighton F, Rigotti A. [Validation of self-applicable questionnaire for a Mediterranean dietary index in Chile]. Rev Med Chil. 2016 Dec;144(12):1531-1543. doi: 10.4067/S0034-98872016001200004. Spanish. PMID 28393987
• Raj R, Koli DK, Bhalla AS, Jain V, Manchanda S, Nanda A. Effect of rehabilitation by using the shortened dental arch concept on the thickness of the masseter muscle and occlusal force: A pilot study. J Prosthet Dent. 2023 Nov;130(5):698-704. doi: 10.1016/j.prosdent.2021.12.009. Epub 2022 Jan 15. PMID 35042607
• Suzuki H, Kanazawa M, Komagamine Y, Iwaki M, Jo A, Amagai N, Minakuchi S. The effect of new complete denture fabrication and simplified dietary advice on nutrient intake and masticatory function of edentulous elderly: A randomized-controlled trial. Clin Nutr. 2018 Oct;37(5):1441-1447. doi: 10.1016/j.clnu.2017.07.022. Epub 2017 Aug 5. PMID 28830699
• Thomson WM, van der Putten GJ, de Baat C, Ikebe K, Matsuda K, Enoki K, Hopcraft MS, Ling GY. Shortening the xerostomia inventory. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Sep;112(3):322-7. doi: 10.1016/j.tripleo.2011.03.024. Epub 2011 Jul 16. PMID 21684773
• Veale JF. Edinburgh Handedness Inventory - Short Form: a revised version based on confirmatory factor analysis. Laterality. 2014;19(2):164-77. doi: 10.1080/1357650X.2013.783045. Epub 2013 May 10. PMID 23659650
• Rivera D, Perrin PB, Stevens LF, Garza MT, Weil C, Saracho CP, Rodriguez W, Rodriguez-Agudelo Y, Rabago B, Weiler G, Garcia de la Cadena C, Longoni M, Martinez C, Ocampo-Barba N, Aliaga A, Galarza-Del-Angel J, Guerra A, Esenarro L, Arango-Lasprilla JC. Stroop Color-Word Interference Test: Normative data for the Latin American Spanish speaking adult population. NeuroRehabilitation. 2015;37(4):591-6 PMID 26639926
• Munoz-Neira C, Henriquez Ch F, Ihnen J J, Sanchez C M, Flores M P, Slachevsky Ch A. [Psychometric properties and diagnostic usefulness of the Addenbrooke's Cognitive Examination-Revised in a Chilean elderly sample]. Rev Med Chil. 2012 Aug;140(8):1006-13. doi: 10.4067/S0034-98872012000800006. Spanish. PMID 23282773
• Neyraud E, Palicki O, Schwartz C, Nicklaus S, Feron G. Variability of human saliva composition: possible relationships with fat perception and liking. Arch Oral Biol. 2012 May;57(5):556-66. doi: 10.1016/j.archoralbio.2011.09.016. Epub 2011 Oct 22. PMID 22024405

Identifiers

NCT: NCT07692828 · 1230616 · 1230616

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗