Oral HygieneNCT06444490
Oral Hygiene Among Portuguese Older Adults
A study testing General Approach Instruction and Personalised Technique Instruction in people with Oral Hygiene and Oral Health, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Oral Health, Older
- What is being tested?
- General Approach Instruction and Personalised Technique Instruction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 30 Jan 2023to 29 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Being edentulous;
- Being institutionalized;
- Having disabilities such as blindness, deafness, or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Oral Hygiene Instruction Methods on Oral Hygiene Behaviour Among 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?
Read more
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.
Read the detailed description
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.
- Conditions
- Oral Hygiene, Oral Health, Older
- Being tested
- General Approach Instruction, Personalised Technique Instruction
- Keywords
- oral hygiene, oral health, health motivation, toothbrushing, dental devices, self-perception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Approach InstructionBehavioural
Oral health instruction focused more broadly on the different topics of oral diseases and oral hygiene care.
Personalised Technique InstructionBehavioural
Oral health instruction based on the specific needs of each participant.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Personalised Technique Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brushing frequency
Assessment of toothbrushing frequency (<2x/day or ≥ 2x/day)
Measured: 2 months
Interdental devices usage
Assessment of dental floss or interdental brushes usage (yes/no)
Measured: 2 months
Denture hygiene
Assessment of daily denture cleaning (yes/no)
Measured: 2 months
Denture care
Assess whether participants sleep with their dentures in (yes/no)
Measured: 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.
Measured: 2 months
Treatment needs (oral clinical observation)
Assessment of participants' treatment needs (yes/no)
Measured: 2 months
Secondary outcomes (3)
Self-perception of oral health
Assess the participants' perception of oral health (poor/good)
Measured: 2 months
Xerostomia
Assessment of dry mouth perception (yes/no)
Measured: 2 months
Perceived treatment needs
Assessment of participants' perception of need for treatment (yes/no)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start30 Jan 2023
- Primary completion29 May 2023
- Study completion29 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inês C Santos, MSc, Principal investigator, Egas Moniz School of Health & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444490
- Sponsor's protocol ID
- PHDICS
- Status last verified
- May 2024
- First submitted
- 29 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie will result in a publication.
Publications
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.
PubMed 14076341
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Hygiene Instruction Methods on Oral Hygiene Behaviour Among Older Adults
- ClinicalTrials.gov ID
- NCT06444490
- Acronym / sponsor ID
- PHDICS
- Conditions
- Oral Hygiene, Oral Health, Older
- Keywords
- oral hygiene, oral health, health motivation, toothbrushing, dental devices, self-perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Approach (GA) | Active comparator | Behavioral: General Approach InstructionThis 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. |
| Personalised Technique (PT) | Active comparator | Behavioral: Personalised Technique InstructionThis 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Being edentulous;
- Being institutionalized;
- Having disabilities such as blindness, deafness, or dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General Approach InstructionOral health instruction focused more broadly on the different topics of oral diseases and oral hygiene care. | Behavioural | General Approach (GA) |
| Personalised Technique InstructionOral health instruction based on the specific needs of each participant. | Behavioural | Personalised Technique (PT) |
Primary outcome
Brushing frequency
Time frame: 2 months
Assessment of toothbrushing frequency (<2x/day or ≥ 2x/day)
Interdental devices usage
Time frame: 2 months
Assessment of dental floss or interdental brushes usage (yes/no)
Denture hygiene
Time frame: 2 months
Assessment of daily denture cleaning (yes/no)
Denture care
Time frame: 2 months
Assess whether participants sleep with their dentures in (yes/no)
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.
Treatment needs (oral clinical observation)
Time frame: 2 months
Assessment of participants' treatment needs (yes/no)
3 secondary outcomes
Self-perception of oral health
Time frame: 2 months
Xerostomia
Time frame: 2 months
Perceived treatment needs
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 14076341GREENE 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie will result in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inês C Santos, MSc principal investigator
Egas Moniz School of Health & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Approach Instruction and Personalised Technique Instruction in people with Oral Hygiene and Oral Health, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brushing frequency (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06444490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.