NCT06444490

Brief Summary

The goal of this clinical trial was to compare two different oral hygiene instruction methods on oral hygiene behavior in older adults. We also wanted to evaluate the self-perception of oral health changes with each instruction method. The main questions we aim to answer were:

  • Which method has better results in changing oral hygiene habits?
  • Which method has better results in reducing bacterial plaque? Participants:
  • Completed a questionnaire about socioeconomic aspects and oral hygiene habits;
  • Were examined to assess their oral hygiene status;
  • Completed a questionnaire about self-perception of oral health;
  • Received oral hygiene instruction (depending on the group: Generalised Approach or Personalised Technique). Two months later, they were assessed again on oral hygiene habits, oral hygiene status, and self-perception of oral health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
Last Updated

June 5, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

May 29, 2024

Last Update Submit

June 4, 2024

Conditions

Keywords

oral hygieneoral healthhealth motivationtoothbrushingdental devicesself-perception

Outcome Measures

Primary Outcomes (6)

  • Brushing frequency

    Assessment of toothbrushing frequency (\<2x/day or ≥ 2x/day)

    2 months

  • Interdental devices usage

    Assessment of dental floss or interdental brushes usage (yes/no)

    2 months

  • Denture hygiene

    Assessment of daily denture cleaning (yes/no)

    2 months

  • Denture care

    Assess whether participants sleep with their dentures in (yes/no)

    2 months

  • Oral Hygiene Clinical Indicator

    Assessment of Oral Hygiene Index - Simplified (OHI-S) (Greene \& Vermillion, 1964). The six surfaces examined for the OHI-S are selected from four posterior and two anterior teeth. For posterior teeth, the buccal surfaces of the selected upper molars (usually 16 and 26) and the lingual surfaces of the selected lower molars (usually 36 or 46) are examined. For the incisors, the labial surfaces of the upper right central incisor (11) and the lower left central incisor (31) are evaluated. A score from 0 to 3 was then recorded for each surface, according to the classification for each index (debris or calculus). For each participant, the debris or calculus index was obtained by summing the scores and dividing by the number of surfaces scored. The Simplified Oral Hygiene Index is the sum of the Debris Index and the Calculus Index and can range from 0 to 6, with higher scores indicating poorer oral hygiene.

    2 months

  • Treatment needs (oral clinical observation)

    Assessment of participants' treatment needs (yes/no)

    2 months

Secondary Outcomes (3)

  • Self-perception of oral health

    2 months

  • Xerostomia

    2 months

  • Perceived treatment needs

    2 months

Study Arms (2)

General Approach (GA)

ACTIVE COMPARATOR

This approach consisted of a 15-minute session in which the dentist attempted to impart knowledge about oral hygiene in general, highlighting some of the most common situations in this age group, namely the difficulty in achieving correct brushing and flossing, demonstrating the correct technique on a typodont (model), and alerting them to the importance of oral health to general health. Periodontal disease, tooth decay and denture care were also covered in general terms. Participants were given a written explanatory guide to reinforce good oral hygiene habits and an explanation of these diseases or conditions. Appropriate oral hygiene tools were also provided to encourage the expected improvement in oral health. Finally, there was a question-and-answer session to clarify any doubts the participant might have.

Behavioral: General Approach Instruction

Personalised Technique (PT)

ACTIVE COMPARATOR

This approach began with a self-examination in an extra-oral mirror by the participant to allow the professional to understand participant's perception of oral health, and the use of a plaque-disclosing solution to allow the participant to be more sensitive to the areas where brushing and flossing were not effective. Conditions such as caries lesions, major gingival recessions, areas of greater inflammation, areas where plaque accumulation or even tartar was more visible and further denture care were highlighted. The typodont (model) was then used to demonstrate the correct brushing and flossing technique. The session ended with the participant receiving an explanatory guide, a personalized plan, and more appropriate tools to promote the expected improvement in oral health. A question-and-answer session was used to clarify any doubts. This method took about approximately 20 minutes.

Behavioral: Personalised Technique Instruction

Interventions

Oral health instruction focused more broadly on the different topics of oral diseases and oral hygiene care.

General Approach (GA)

Oral health instruction based on the specific needs of each participant.

Personalised Technique (PT)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being able to speak and understand Portuguese;
  • Being able to understand and sign an informed consent form;
  • Being literate and able to comply with the study protocol.

You may not qualify if:

  • Being edentulous;
  • Being institutionalized;
  • Having disabilities such as blindness, deafness, or dementia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz Dental Clinic

Almada, Caparica, 2825-083, Portugal

Location

Related Publications (1)

  • GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

    PMID: 14076341BACKGROUND

Study Officials

  • Inês C Santos, MSc

    Egas Moniz School of Health & Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 5, 2024

Study Start

January 30, 2023

Primary Completion

May 29, 2023

Study Completion

May 29, 2023

Last Updated

June 5, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

All IPD that underlie will result in a publication.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
IPD will become available immediately after publication.
Access Criteria
Data will be available upon reasonable request. The Principal Investigator will review requests.

Locations