Oral Health Status in Care-dependent Community Dwelling Elders

NCT04656327 | Unknown

• 1 other identifier: UZH_ABS_2020_2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this cross-sectional survey in Zurich is to assess the oral health status (OHS), Oral Health Related Quality of Life (OHRQoL), and the nutritional status (NS) of community-dwelling elders dependent for care. The secondary objective of this study evaluates whether the OHS, OHRQoL and NS are influenced by cognitive status, level of dependency, socio-economic status and level of education. The tertiary objective is to assess whether the quality of nutritional uptake (refrigerator content) by the community-dwelling elders dependent for care is influenced by OHS/function, level of dependency, cognitive impairment, socio-economic status or level of education and the proximity and/or access to food sources (supermarkets).

Conditions

Oral-health; Nutritional Status

Outcome Measures

Primary Outcomes (14)

• Plaque Index

  Sillness and Löe Plaque index: The index measures the state of oral hygiene based on the amount of soft and mineralised debris present on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the observed debris state on its four surfaces (Labial/Buccal, Mesial, Distal \& Palatal/Lingual): 0- No plaque 1. A film of plaque adhering to the free gingival margin (plaque detectable only by probing) 2. Moderate accumulation of plaque (plaque perceivable by naked eye and interdental space is free). 3. Abundance of plaque (Interdental space is filled with plaque) x- Tooth not present. The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the plaque index for the patient.

  Day 1

• Gingival index

  Löe and Silness Gingival Index : The index measures the degree of inflammation of the gingiva on the 6 indexed teeth (teeth no. 16, 12, 24, 36, 32 \& 44). The following grades will be allotted to the teeth based on the bleeding present after a careful probing of the gingival sulcus: 0- Normal gingiva (No inflammation, no discolouration, no bleeding, no loss of stippling) 1. Low inflammation (slight color change, no bleeding) 2. Moderate inflammation (redness, oedema, bleeding on probing, loss of stippling). 3. Severe inflammation (redness, oedema, tendency to spontaneously bleed, ulceration, loss of stippling) x- Tooth not present The four scores per tooth are summed and an average per tooth is calculated for that tooth. Then the mean of all the individual average scores of the examined teeth is calculated. This number gives us the gingival index for the patient.

  Day 1

• DMF(T)

  Decayed, Missing, Filled (Teeth) index: Each tooth present in the mouth will be graded as either decayed, missing or filled. Then all the numbers are added up to give us the DMF(T) status of the patient.

  Day 1

• CPITN index

  This index measures the state of the oral health in terms of periodontal disease and the treatment needs for the patient. All the teeth are examined and the most affected tooth per sextant is awarded a score. The following scores are possible for the teeth examined: 0- healthy (No bleeding on probing, no marginal irritation, no pockets): No treatment. 1. No pockets, Bleeding on Probing, no calculus, no overhangs. Treatment: Oral hygiene instructions (OHI) 2. Pockets \<3mm, sub gingival calculus present, and/or iatrogenic marginal irritations (overhanging restoration margins). Treatment: OHI, scaling and correction of overhangs. 3. Deepest pockets between 4 and 5 mm. Treatment: OHI, Scaling and root planing. 4. Probing depth \>6 mm. Treatment: Scaling \& root planing, and/or flap as required. * \- furcation is involved and/or a total loss of attachment \>7mm is present. Treatment: Full periodontal examinations of all sextants regardless of CPITN score.

  Day 1

• Dentition Status

  Assessment of status of dentition in the mouth. The examination will classify the edentulism present in the jaw as either completely edentate or partially dentate. And if Partially edentate, then the Kennedy's Classification will be applied to classify the partial edentulism present in the jaw. We will also examine if the edentulism present is rehabilitated with what type of prosthesis ( fixed dental prosthesis/removabnle dental prosthesis/Implant supported fixed dental prosthesis or implant supported removable dental prosthesis)

  Day 1

• Denture Calculus index (DCI)

  Denture calculus index measures the amount of soft and hard debris present on the removable dental prosthesis. The following grades are allotted based on the presence of the debris on the prosthesis: 0- No visible plaque 1. Plaque visible only by scrapping 2. Moderate visible plaque 3. Abundant plaque present

  Day 1

• Maximum bite force (MBF)

  Maximum bite force is measured using a bite force meter. The patient will be requested to bite on the bite force meter first on the right side. The patient will then be requested to do the same on the left side. Three observations will be recorded for each side. The mean of the maximum bite force from both sides will be calculated and used for the analysis.

  Day 1

• Chewing function (CE)

  Chewing function is measured using a bi-color chewing gum. The patient will chew on the chewing gums for 20 chewing cycles. The gum is flattened to a wafer thickness of 1 mm. Both sides of this wafer are scanned with a flat-bed photo scanner. The two images are brought together on a single frame using a photo software. This single image is then imported into a software (ViewGum). The software calculates the variance of hue (VoH) for each chewing gum. VoH is a numerical value and the lower the value better is the chewing efficiency. A visual subjective assessment (SA) of the chewing gums will also be performed. The following grades will be allotted: SA1- Chewing not mixed, only impressions of cusps are p\[resent or the chewing appears folded without being mixed. SA2- Large parts of the chewing gums are mixed. SA3- Bolus slightly mixed but bits of unmixed original color still present. SA4- Bolus well mixed, but color not uniform. SA5- Bolus perfectly mixed with uniform color.

  Day 1

• Oral health impact profile 14-items (OHIP-14)

  OHIP-14 measures the Quality of life related to oral health. It is a subjective assessment which captures 7 dimensions (Functional limitation, Physical pain, Psychological discomfort, Physical disability, Psychological disability, Social disability and Handicap) by the means of 14- items. The participant must respond with a Likert scale-type response (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score, the better the Oral health related Quality of life (OHRQoL).

  Day 1

• European Quality of Life - 5 Dimensions (EQ-5D)

  EQ-5D measures the general health status not specific to a disease. There are 5 dimensions (Mobility, self care, usual activities, pain/discomfort, and anxiety/depressions). There is one question per dimension and a possible Likert scale response type with three options (1- No problems, 2-Some problems, 3-Too much problems). A score between 1 and 3 is given to each of the dimensions.

  Day 1

• Xerostomia Inventory with 11-items (XI-11)

  XI-11 assesses the xerostomia state of the participant. There are 11 questions in the inventory and the patient has the possibility to respond with a Likert-scale type response type (4-Very often, 3-Often, 2-from time to time, 1- rarely, 0-Never). The lower the score the better the index and shows the absence/reduced xerostomia.

  Day 1

• Mini-Nutritional Assessment (MNA)

  The MNA instrument measures the nutritional state of the patient and its primary targets are under- and malnutrition states. The instrument has a two-stage structure and anamnesis with 6 items with a further 12 items including two anthropometric measurements (upper arm circumference and calf circumference). The maximum score is 30 points. The scale is: 17-23.5: risk for malnutrition \<17: poor nutritional state

  Day 1

• Refrigerator Content

  In this, we will make a record of all the items present in the participants refrigerator. All the items present will be assessed for validity of expiry and nutritional values will be calculated based on the information present on the box/label.

  Day 1

• Oral hygiene tools and maintenance

  In this outcome, information on the frequency of the oral hygiene performed, the tools employed, condition of the oral hygiene tools present will be collected.

  Day 1

Study Arms (1)

Non interventional group

Community-dwelling elders dependent for care

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this study. It is a cross-section study evaluating the oral health and nutritional statuses of community-dwelling elders dependent for care for their activities of daily living.

Non interventional group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly population living in the canton of Zurich, who are care-dependent and community- dwelling receiving out-patient care.

You may qualify if:

• Signed informed consent
• Living in their residence in the canton of Zurich but dependent for care for their Activities of Daily Living (ADLs)

You may not qualify if:

• Not willing or able to sign informed consent or not given by the caregiver/guardian.
• Age \< 65 years
• Non-responsive / not cooperative for examination

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Clinic of General, Special care, and Geriatric Dentistry, Center of Dental Medicine, University of Zurich

Zurich, 8032, Switzerland

RECRUITING

Study Officials

• Murali Srinivasan, BDS, MDS, MBA, MAS

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lea Angst, Med. dent.

CONTACT

+41 795790054; lea.angst@zzm.uzh.ch

Elena van der Heijden

CONTACT

+41 44 6343341; Elena.vanderHeijden@zzm.uzh.ch

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 7, 2020
• Study Start: September 26, 2020
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)