Clinical trial NCT05777980: Effect of Prosthetic Rehabilitation on Nutritional Status of Geriatric Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutrition Disorders
Edentulous Jaw
Keywords: Aged Nutrition Physiology
Dental implants
Overdenture
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in chewing ability
timeFrame: 9 months
measure: Change in Malnutrition Status
timeFrame: 9 months
measure: Change in food consumption
timeFrame: 9 months
measure: Change in body composition
timeFrame: 9 months
Secondary outcomes:
measure: Change in Oral-Health Impact Profile
timeFrame: 9 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Dentistry
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Slade GD, Spencer AJ. Development and evaluation of the Oral Health Impact Profile. Community Dent Health. 1994 Mar;11(1):3-11.
citation: 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.
citation: 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.