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Nutrition DisordersNCT05777980

Effect of Prosthetic Rehabilitation on Nutritional Status of Geriatric Patients

An observational study of Nutrition Disorders and Edentulous Jaw, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study examines the effects of prosthetic treatment options applied to edentulous geriatric individuals who applied to Marmara University Faculty of Dentistry on chewing function, food consumption status, malnutrition status and oral health-related quality of life. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Nutrition Disorders, Edentulous Jaw
How many people
37 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 May 2021to 1 Jun 2023
Phase
Observational
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 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients over 50, who were admitted to Marmara University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, to have two implant-supported overdenture prostheses made, will be included in the study.

Who may be able to join

  • ≥ 50 years old,
  • Those who volunteer to participate in the study,
  • Those who have adequate bone height and thickness in the intraforaminal region
  • Those who have Upper and lower fully edentulous jaws

Who cannot join

  • Those who have systemic diseases that may cause systemic neuropathy, such as diabetes, hypertension, kidney disease,
  • Those who do not want to sign the consent form,
  • Clinical or radiographic pathological condition in the intraforaminal region
  • Patients with a history of malignancy, radiotherapy or chemotherapy will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Marmara University School of Dentistry

    Istanbul, 34854

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluating the Nutrition Status and Oral Health Impact Profile (OHIP) in Fully Edentulous Patients After Implant-supported Overdenture Rehabilitation: A Prospective Observational Follow-up Study

This study examines the effects of prosthetic treatment options applied to edentulous geriatric individuals who applied to Marmara University Faculty of Dentistry on chewing function, food consumption status, malnutrition status and oral health-related quality of life.

Keywords
Aged Nutrition Physiology, Dental implants, Overdenture
Medical subject headings
Nutrition Disorders, Jaw, Edentulous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in chewing ability

    In this study, a questionnaire consisting of open and closed-ended questions will be used to determine the chewing difficulties of individuals. With open-ended questions, foods that are difficult to chew and the methods used to consume these foods will be questioned. In the follow-up interviews, closed-ended questions such as the ability to chew the previously listed foods are "easy to chew", "I have a little difficulty", "I have a lot of difficulty / can't chew at all". If individuals say, "I have a little or a lot of difficulty" while chewing hard foods and "I have some or a lot of difficulty" when chewing soft foods, they will be evaluated as "difficulty in chewing". At baseline, 3 months after temporary complete denture treatment, 3 and 6 months after implant-supported overdenture treatment, the chewing ability will be determined.

    Measured: 9 months

  2. Change in Malnutrition Status

    The Mini Nutritional Assessment (MNA) will be used to assess changes in nutritional status. MNA is an easy-to-apply, low-cost and reliable method that is frequently used in the evaluation of malnutrition status. The MNA consists of 4 parts. These four parts; anthropometric assessment (BMI, weight, arm and calf circumferences); general status assessment (lifestyle, medication, mobility, cognition/depression); short nutritional assessment (number of full meals, food and liquids intake, self-sufficiency in eating) and subjective assessment (self-perception about health and nutrition status). MNA classifies elderly patients as good status (scores ≥ 24), risk of malnutrition (scores between 17-23.5), or malnourished (scores <17). MNA will be applied by the researchers in face-to-face meetings within baseline, 3 months after temporary complete denture treatment, 3 and 6 months after implant-supported overdenture treatment

    Measured: 9 months

  3. Change in food consumption

    To evaluate the food consumption of the geriatric individuals included in the study, at baseline, 3 months after temporary complete denture treatment, 3 and 6 months after implant-supported overdenture treatment will be taken with 24-hour recall method. The amount of nutrients included in the meals will be calculated by using the "Standard Recipes" book, and the measurement amounts will be calculated by using the "Food Photo Catalogue" book. The data obtained from the 24-hour recall method will be analyzed using the "Computer Assisted Nutrition Program, Nutrition Information Systems Package Program (BEBIS)" and the amount of energy, carbohydrates, protein, fat, fiber and micronutrients consumed by participants will be calculated. Intake of energy, macro nutrients, fiber and micronutrients will be compared with the baseline, 3 months after temporary complete denture treatment, 3 and 6 months after implant-supported overdenture treatment.

    Measured: 9 months

  4. Change in body composition

    Body composition consists of body fluid, body fat, muscle mass and bone components. The sum of bone and muscle mass gives lean body mass. For body composition analysis, an 8-electrode bioelectrical impedance (BIA) device Tanita MC 780 MA, which performs segmental analysis, will be used. Individuals will be asked to remove all metal items (rings, earrings, bracelets, watches, phones, etc.), any heavy clothing, shoes, and socks before stepping on the device. The device is set to -1.0 kg for the remaining clothes. With this measurement, which takes about 1 minute, the body weight (kg), total body fluid (kg), total body fat (kg), lean body mass (kg) and muscle mass (kg) values will be obtained.

    Measured: 9 months

Secondary outcomes (1)

  1. Change in Oral-Health Impact Profile

    A scale of 1 to 5 will be used to rate each of the 14 questions about how dental health affects quality of life (minimum score of 0, maximum score of 70). Higher ratings reflect a greater influence of the patient's dental health on their quality of life (higher scores, worse outcomes). At baseline, 3 months after temporary complete denture treatment, 3 and 6 months after implant-supported overdenture treatment, the questionnaire will be taken.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start28 May 2021
  3. Primary completion6 Jan 2023
  4. Study completion1 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05777980
Sponsor's protocol ID
MU_DHF_SBF_04
Status last verified
Jul 2023
First submitted
16 Feb 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Akoglu B, Ucankale M, Ozkan Y, Kulak-Ozkan Y. Five-year treatment outcomes with three brands of implants supporting mandibular overdentures. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):188-94.

    PubMed 21365055

  • Cousson PY, Bessadet M, Nicolas E, Veyrune JL, Lesourd B, Lassauzay C. Nutritional status, dietary intake and oral quality of life in elderly complete denture wearers. Gerodontology. 2012 Jun;29(2):e685-92. doi: 10.1111/j.1741-2358.2011.00545.x. Epub 2011 Oct 17.

    PubMed 22004061

  • Kossioni A, Bellou O. Eating habits in older people in Greece: the role of age, dental status and chewing difficulties. Arch Gerontol Geriatr. 2011 Mar-Apr;52(2):197-201. doi: 10.1016/j.archger.2010.03.017.

    PubMed 20399518

  • Lamy M, Mojon P, Kalykakis G, Legrand R, Butz-Jorgensen E. Oral status and nutrition in the institutionalized elderly. J Dent. 1999 Aug;27(6):443-8. doi: 10.1016/s0300-5712(99)00002-0.

    PubMed 10399411

  • Sheiham A, Steele JG, Marcenes W, Lowe C, Finch S, Bates CJ, Prentice A, Walls AW. The relationship among dental status, nutrient intake, and nutritional status in older people. J Dent Res. 2001 Feb;80(2):408-13. doi: 10.1177/00220345010800020201.

    PubMed 11332523

  • Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.

    PubMed 8193981

  • Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol. 1997 Aug;25(4):284-90. doi: 10.1111/j.1600-0528.1997.tb00941.x.

    PubMed 9332805

  • Ucankale M, Akoglu B, Ozkan Y, Ozkan YK. The effect of different attachment systems with implant-retained overdentures on maximum bite force and EMG. Gerodontology. 2012 Mar;29(1):24-9. doi: 10.1111/j.1741-2358.2010.00389.x. Epub 2010 Jun 30.

    PubMed 20604812

Questions about this trial

What is this clinical trial studying?

An observational study of Nutrition Disorders and Edentulous Jaw, run by Marmara University at 1 site in Turkey (Türkiye).

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 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 Turkey (Türkiye). 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in chewing ability (time frame: 9 months). The study lists 4 primary outcomes in all. 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 NCT05777980, which also lists 8 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 10 Jul 2023.

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