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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06444490
Other study ID # PHDICS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date May 29, 2023

Study information

Verified date May 2024
Source Egas Moniz - Cooperativa de Ensino Superior, CRL
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 29, 2023
Est. primary completion date May 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
General Approach Instruction
Oral health instruction focused more broadly on the different topics of oral diseases and oral hygiene care.
Personalised Technique Instruction
Oral health instruction based on the specific needs of each participant.

Locations

Country Name City State
Portugal Egas Moniz Dental Clinic Almada Caparica

Sponsors (1)

Lead Sponsor Collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL

Country where clinical trial is conducted

Portugal, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brushing frequency Assessment of toothbrushing frequency (<2x/day or = 2x/day) 2 months
Primary Interdental devices usage Assessment of dental floss or interdental brushes usage (yes/no) 2 months
Primary Denture hygiene Assessment of daily denture cleaning (yes/no) 2 months
Primary Denture care Assess whether participants sleep with their dentures in (yes/no) 2 months
Primary 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
Primary Treatment needs (oral clinical observation) Assessment of participants' treatment needs (yes/no) 2 months
Secondary Self-perception of oral health Assess the participants' perception of oral health (poor/good) 2 months
Secondary Xerostomia Assessment of dry mouth perception (yes/no) 2 months
Secondary Perceived treatment needs Assessment of participants' perception of need for treatment (yes/no) 2 months
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