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Empowering Older Adults for Healthy Living and Better Dental Health

Primary Purpose

Periodontal Diseases, Dental Caries

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Theory-derived intervention
Conventional health education
Sponsored by
National University of Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Periodontal Diseases focused on measuring oral health, health behaviours, periodontal disease, theory-derived intervention

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 55-70 years old
  • Living in the community (alone or with family members), instead of residing in a nursing home
  • Having at least 8 natural teeth
  • No plan to immigrate in 3 years

Exclusion Criteria:

• Life-threatening disease; impaired cognitive function (e.g. Alzheimer's syndrome); radiotherapy in the head and neck region

Sites / Locations

  • Faculty of Dentistry, National University of SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Theory-derived intervention

Conventional health education

Arm Description

Questionnaire will be used including the scales for three dominant theoretical models, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours of the selected participants will be selected for designing oral health intervention.The theory-derived intervention will address the constructs/domains of the selected model(s) in the context of the three target behaviours (diet, toothbrushing and dental flossing).

Participants will be randomly assigned to the control group, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes.

Outcomes

Primary Outcome Measures

Increment of coronal caries
Number of new surfaces with coronal caries
Increment of root caries
Number of new surfaces with root caries

Secondary Outcome Measures

Change in dietary behaviours (favourable/unfavourable)
Using a questionnaire, dietary behaviours will be categorised into: favourable (frequency of snack intake, sweet/desert intake and/or sugary drinks <2times/day) unfavourable (frequency of snack intake, sweet/desert intake and/or sugary drinks >=2times/day)
Change in toothbrushing behaviours (favourable/unfavourable)
Using a questionnaire, toothbrushing behaviours will be categorised as: favourable (frequency of brushing >=2times/day) unfavourable (frequency of brushing <2times/day)
Change in flossing behaviours (favourable/unfavourable)
Using questionnaire to evaluate frequency of flossing (with >=once/day considered as favourable and <once/day considered unfavourable)
Change in oral hygiene status (plaque score)
Presence or absence of dental plaque on tooth surfaces
Change in periodontal condition
Number of sites with deep periodontal pockets, shallow periodontal pockets, and gingival bleeding only

Full Information

First Posted
June 7, 2021
Last Updated
March 22, 2023
Sponsor
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT04946292
Brief Title
Empowering Older Adults for Healthy Living and Better Dental Health
Official Title
Developing and Evaluating a Theory-derived Intervention to Improve Oral Health of Community-dwelling Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Ageing of the world's population is accelerating. Despite the health challenges they face, older people should not be stereotyped as frail and dependent. Healthy ageing is possible if adequate care is provided and effective intervention is delivered for healthy living. Common oral diseases (dental caries and periodontal diseases) are determined to a great extent by health behaviours (diet and oral hygiene) and are controllable through effective interventions. Hence, this study aims to test the theoretical models for health promotion, develop theory-derived intervention, and evaluate its effectiveness in improving oral health of older adults. The study hypothesis is that theory-derived intervention is more effective than conventional health education in eliciting positive behaviours and controlling oral diseases in older adults.
Detailed Description
This study targets older adults and aims to (i) test the explanatory power of the dominant theoretical models/ frameworks, (ii) develop theory-derived intervention, and (iii) evaluate the effectiveness of the theory-derived intervention. The hypothesis is that theoretical-derived intervention is more effective than conventional health education in improving oral health behaviours and preventing oral diseases among older adults. The sample size needed for this study was calculated by using the software G*Power version 3.1.9.2 (Franz Faul, University of Kiel, Germany). The sample size calculation was based on the primary outcomes, namely increment of coronal caries and increment of root caries, and independent t-tests for comparing means of two independent groups. A caries incidence study among the elderly reported that the mean (SD) 5-year caries incidence were 2.65 (3.14) for coronal caries and 2.21 (2.83) for root caries 17. The 2-year incidence of coronal caries and root caries were therefore estimated to be 1.06 (1.26) and 0.88 (1.13), respectively, in the control group. The effect of an intervention is considered clinically significant if it reduces the caries incidence by 40%. Based on a significance level of 5% and a power of 80%, 140 subjects per group are needed for coronal caries and 165 subjects are needed for root caries outcome measures. To take both outcome measures into account, the higher number (i.e., n=165) will be adopted. Allowing for a 25% attrition rate, 220 elderly persons will need to be recruited into each group, giving a total sample size of 440. Each participant will be required to complete a detailed questionnaire at the initial visit through face-to-face interviews. Information on socio-demographic background (gender, age, education level, past occupation, and type of housing) and oral health behaviours (diet, toothbrushing and dental flossing) will be collected. The questionnaire will also include the scales for three dominant theoretical models, namely, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours will be selected for designing oral health intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). Relevant medical literatures will be referred to. The needs, interest, and health literary of the target group (i.e. older adults of varied social and educational backgrounds) will be taken into full consideration. The intervention will be tested in a small group of 15-20 older people to ensure its relevance, practicality, and acceptability. Participants will be randomly assigned to two groups, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes. The two groups will receive conventional health education and theory-derived intervention, respectively. At baseline and 6-, 12-, and 24-months post-intervention, each participant will a) undergo an oral examination (dental checkup) by a trained dentist, who will be calibrated against an experienced oral epidemiologist and blinded to the group allocation, and b) complete a questionnaire (detailed questionnaire at baseline and short questionnaire for follow-ups). Chi-square tests will be used for comparing proportions. Parametric or non-parametric methods will be adopted for comparing means. ANCOVA (analysis of covariance) and multiple regressions will be performed to evaluate the effects of various factors on the outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Dental Caries
Keywords
oral health, health behaviours, periodontal disease, theory-derived intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Theory-derived intervention
Arm Type
Experimental
Arm Description
Questionnaire will be used including the scales for three dominant theoretical models, Health Belief Model (HBM), Theory of planned behaviour (TPB) and Social Cognitive Theory (SCT). The theoretical model that best explains the health behaviours of the selected participants will be selected for designing oral health intervention.The theory-derived intervention will address the constructs/domains of the selected model(s) in the context of the three target behaviours (diet, toothbrushing and dental flossing).
Arm Title
Conventional health education
Arm Type
Active Comparator
Arm Description
Participants will be randomly assigned to the control group, stratified by gender and education level. Allocation concealment will be ensured by using sealed opaque envelopes.
Intervention Type
Behavioral
Intervention Name(s)
Theory-derived intervention
Intervention Description
The intervention will be delivered through multimedia materials and group activities, as appropriate. Participants will spend approximately 30-45 minutes for the intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, brushing, flossing) and clinical outcomes (oral hygiene, caries and periodontal conditions).
Intervention Type
Behavioral
Intervention Name(s)
Conventional health education
Intervention Description
The conventional health education will be delivered through an oral health talk and oral health booklet. Topics covered are: (i) common oral diseases and its consequences; (ii) common dental problems among older adults; (iii) importance of oral health measures (healthy diet, toothbrushing and dental flossing); and (iv) proper techniques for toothbrushing and dental flossing.
Primary Outcome Measure Information:
Title
Increment of coronal caries
Description
Number of new surfaces with coronal caries
Time Frame
From baseline to 2 years post-intervention
Title
Increment of root caries
Description
Number of new surfaces with root caries
Time Frame
From baseline to 2 years post-intervention
Secondary Outcome Measure Information:
Title
Change in dietary behaviours (favourable/unfavourable)
Description
Using a questionnaire, dietary behaviours will be categorised into: favourable (frequency of snack intake, sweet/desert intake and/or sugary drinks <2times/day) unfavourable (frequency of snack intake, sweet/desert intake and/or sugary drinks >=2times/day)
Time Frame
From baseline to 2 years post-intervention
Title
Change in toothbrushing behaviours (favourable/unfavourable)
Description
Using a questionnaire, toothbrushing behaviours will be categorised as: favourable (frequency of brushing >=2times/day) unfavourable (frequency of brushing <2times/day)
Time Frame
From baseline to 2 years post-intervention
Title
Change in flossing behaviours (favourable/unfavourable)
Description
Using questionnaire to evaluate frequency of flossing (with >=once/day considered as favourable and <once/day considered unfavourable)
Time Frame
From baseline to 2 years post-intervention
Title
Change in oral hygiene status (plaque score)
Description
Presence or absence of dental plaque on tooth surfaces
Time Frame
From baseline to 2 years post-intervention
Title
Change in periodontal condition
Description
Number of sites with deep periodontal pockets, shallow periodontal pockets, and gingival bleeding only
Time Frame
From baseline to 2 years post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 55-70 years old Living in the community (alone or with family members), instead of residing in a nursing home Having at least 8 natural teeth No plan to immigrate in 3 years Exclusion Criteria: • Life-threatening disease; impaired cognitive function (e.g. Alzheimer's syndrome); radiotherapy in the head and neck region
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gao Xiaoli, PhD
Phone
(65) 67724990
Email
dengx@nus.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao Xiaoli, PhD
Organizational Affiliation
Faculty of Dentistry, National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, National University of Singapore
City
Singapore
ZIP/Postal Code
119085
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoli Gao
Phone
67724990
Email
dengx@nus.edu.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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Empowering Older Adults for Healthy Living and Better Dental Health

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