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Completed

NCT Number: NCT06444490

Oral Hygiene Among Portuguese Older Adults

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egas Moniz Dental Clinic

Almada, Caparica, 2825-083, Portugal

About this study

This study aimed to evaluate the effectiveness of two different oral hygiene instruction methods on oral hygiene behavior in older adults. Secondly, we intended to assess the self-perception of oral health changes with each instruction method.

This study was a clinical trial that included a convenience sample of 60 participants attending a university dental hospital (Egas Moniz Dental Clinic, Almada, Portugal).

Data were collected in two phases: The first phase (baseline) consisted of three parts: a questionnaire focusing on the participant's socioeconomic data and oral hygiene behaviors, clinical records obtained through an intraoral examination, using the Oral Hygiene Index-Simplified (OHI-S), and oral hygiene instruction.

For the oral hygiene instruction, the sample was divided into two groups of 30 participants (n=30) each group, exposed to different methods of professional education. The first one, identified as "General Approach" (GA), focuses more broadly on the different topics of oral diseases and oral hygiene care. The second group, identified as "Personalised Technique" (PT), was based on the specific needs of each participant.

After two months, to establish a follow-up session, the self-reported questionnaire on oral hygiene behavior and self-perceived oral health was administered again and the same clinical records on OHI-S were collected.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

General Approach Instruction

Behavioral

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

Personalised Technique Instruction

Behavioral

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

Primary outcomes

  1. Brushing frequency

    Time frame: 2 months

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

  2. Interdental devices usage

    Time frame: 2 months

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

  3. Denture hygiene

    Time frame: 2 months

    Assessment of daily denture cleaning (yes/no)

  4. Denture care

    Time frame: 2 months

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

  5. Oral Hygiene Clinical Indicator

    Time frame: 2 months

    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.

  6. Treatment needs (oral clinical observation)

    Time frame: 2 months

    Assessment of participants' treatment needs (yes/no)

Secondary outcomes

  1. Self-perception of oral health

    Time frame: 2 months

    Assess the participants' perception of oral health (poor/good)

  2. Xerostomia

    Time frame: 2 months

    Assessment of dry mouth perception (yes/no)

  3. Perceived treatment needs

    Time frame: 2 months

    Assessment of participants' perception of need for treatment (yes/no)

Sponsors and collaborators

Lead sponsor

Egas Moniz - Cooperativa de Ensino Superior, CRL

Other

Registry information

Official study title

Comparison of Oral Hygiene Instruction Methods on Oral Hygiene Behaviour Among Older Adults

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2024
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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