Nutritional Intervention for Older Adults With Complete Dentures

NCT07692828 | Not Yet Recruiting

• 1 other identifier: 1230616
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edentulism Complete; Mastication Disorder; Denture, Complete

Keywords

Nutritional Intervention; Older Adults; Salivary Biomarkers; Cognitive Performance; OHRQoL; Masticatory Performance

Outcome Measures

Primary Outcomes (3)

• Masticatory Performance

  Measurement of food fractionation capacity. Participants will chew a standardized food (peanuts) for 20 cycles; the particles will be dried and processed through a sieving system (sieves from 4.0 mm to 870 μm) to determine the percentage of fractionation.

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Diet Quality Assessment

  Diet quality will be assessed using the Chilean Healthy Eating Index (Índice de Dieta Mediterránea for Chile, IDM-Chile), which allows the evaluation of adherence to healthy dietary patterns in the study population.

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Perceptions of Edentulism and Adaptation to Complete Removable Dentures

  A qualitative assessment using a Grounded Theory framework conducted through semi-structured individual interviews to explore older adults' perceptions regarding their experiences with tooth loss, rehabilitation with complete removable dental prostheses, and their natural functional and social adaptation strategies in daily life. Interviews (30-60 minutes) will be audio-recorded, transcribed verbatim, and analyzed concurrently using ATLAS.ti software through progressive coding (open, axial, and selective) to develop a substantive explanatory model.

  Between month 0 and month 1 (collected during the initial phase of the study to capture prior experiences and avoid intervention bias).

Secondary Outcomes (20)

• Masticatory Kinematics: Number of Chewing Cycles

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Masticatory Kinematics: Chewing Cycle Area

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Masticatory Kinematics: Masticatory Frequency

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Masticatory Kinematics: Masticatory Speed

  T0 (month 0), T1 (month 3) and T2 (month 6).

• Maximum Bite Force

  T0 (month 0), T1 (month 3) and T2 (month 6).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants assigned to the Intervention Group will receive a 6-month educational and nutritional intervention designed for older adults who wear complete removable dentures. The intervention includes in-person nutritional consultation, telephone follow-up nutritional counseling, a dietary guideline booklet adapted for denture wearers, a practical healthy cooking workshop, and monthly food box delivery to support adherence. Additionally, the intervention will be supported by a custom-developed mobile application. Through this digital tool, participants can access the digital version of the dietary guide, view educational and instructional videos uploaded biweekly throughout the 6-month period.

Behavioral: Nutritional Intervention

Control Group

NO INTERVENTION

Participants assigned to the Control Group will maintain their usual diet during the 6-month study period and will undergo the same follow-up assessments as the Intervention Group. To ensure ethical equity, upon study completion, participants in the Control Group will receive full access to the mobile application, a food box, and the dietary guide booklet, and they will be invited to attend a practical healthy cooking workshop led by a nutritionist and a chef.

Interventions

Nutritional Intervention BEHAVIORAL

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 recommendations, weekly menu proposals, healthy recipes and guidance for incorporating foods with different textures and hardness levels, with the aim of stimulating masticatory function according to individual tolerance. 4. Cooking workshop: Will teach participants how to prepare the recipes included in the dietary guidelines booklet. 5. Food box delivery: Monthly supply of non-perishable ingredients. 6. Mobile app: Digital tool providing the digital guide, educational videos and push notifications.

Intervention Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de La Frontera: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Universidad de La Frontera

Temuco, Cautín, 4780000, Chile

Location

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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):591-624. doi: 10.3233/NRE-151281.

  PMID: 26639926 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Fuentes R, Arias A, Lezcano MF, Saravia D, Kuramochi G, Dias FJ. Systematic Standardized and Individualized Assessment of Masticatory Cycles Using Electromagnetic 3D Articulography and Computer Scripts. Biomed Res Int. 2017;2017:7134389. doi: 10.1155/2017/7134389. Epub 2017 Sep 18.

  PMID: 29075647 BACKGROUND

Study Officials

• Ramón Fuentes, PhD

  Universidad de La Frontera

  PRINCIPAL INVESTIGATOR

• Camila Venegas, MSc

  Universidad de La Frontera

  STUDY DIRECTOR

• Gladys Morales, PhD

  Universidad de La Frontera

  STUDY DIRECTOR

• Carlos Zaror, PhD

  Universidad de La Frontera

  STUDY DIRECTOR

Central Study Contacts

Ramón Fuentes, PhD

CONTACT

+56953339044; ramon.fuentes@ufrontera.cl

Camila Venegas, MSc

CONTACT

+56935889866; camilabelen.venegas@ufrontera.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 9, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): May 12, 2028
• Study Completion (Estimated): May 12, 2028
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)