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Oral Health Related Quality of Life (OHRQoL)NCT07648121

Assessment of Oral Health-Related Quality of Life in Preschool-Aged Children in Alto Alentejo

An observational study of Oral Health Related Quality of Life (OHRQoL) and Early Childhood Caries (ECC), run by University of Lisbon at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The observational study aims to improve understanding of Oral Health-Related Quality of Life (OHRQoL) among preschool children in the District of Portalegre, Portugal, by examining the roles of sociodemographic, behavioral, and parental psychosocial factors, as well as the child's oral health status. Read more about this study

Who is it for?
Ages 3 to 5 yearsHealthy volunteers can take part
How many people
454 participants
Where
1 sitePortugal
Study dates
11 Apr 2025to 20 Mar 2026
Phase
Observational
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 3 to 5 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Preschool-aged children attending schools in the district of Portalegre

Who may be able to join

  • All children who attended the selected classrooms were included in the study and who:
  • Were between 3 and 5 years of age at the time of the observation;
  • Had informed consent provided by their parents or legal guardians;
  • Assented to participate in the study

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Faculty of Dental Medicine, University of Lisbon

    Lisbon

Other trials in Portugal

About this study

Official title: Oral Health-Related Quality of Life in a Preschool Population of Alto Alentejo

The observational study aims to improve understanding of Oral Health-Related Quality of Life (OHRQoL) among preschool children in the District of Portalegre, Portugal, by examining the roles of sociodemographic, behavioral, and parental psychosocial factors, as well as the child's oral health status.

The study seeks to answer the following main research question: How do sociodemographic, behavioural, parental psychosocial factors, and the child's oral health status influence the Oral Health-Related Quality of Life (OHRQoL) of preschool children in the District of Portalegre?

Read the detailed description

This observational, analytical, and cross-sectional study aims to deepen understanding of the factors associated with Oral Health-Related Quality of Life (OHRQoL) among preschool children in the Portalegre District.

For participant selection, a probabilistic, multi-stage sampling process, stratified by type of preschool (public or private) and by municipality, was used. The final sample comprises 33 preschools, including 22 public and 11 private.

Data collection comprises two complementary components: a questionnaire completed by parents or caregivers and an intraoral examination for each participating child. The questionnaire comprises seven sections with multiple-choice and open-ended items. It collects information on the child's general health, access to oral healthcare, child and caregiver behaviors, OHRQoL, parental beliefs and attitudes regarding oral health, and sociodemographic characteristics. Distribution is carried out by educators and assistants from the institutions, ensuring delivery to parents or caregivers.

The intraoral examination collected data on oral hygiene, gingival health, the presence of dental caries, malocclusion, and traumatic dental lesions. All records were documented on a standardised form developed for the study. Examinations were carried out in a schoolroom with good natural and artificial lighting, using existing furniture. All infection control and cross-contamination prevention measures were implemented, including the use of disposable gloves and masks, as well as sterilized instruments.

The instruments used included a LED headlight, a flat intraoral mirror, a millimetre ruler, and a CPI (Community Periodontal Index) periodontal probe, in accordance with World Health Organization specifications, with a 0.5 mm ball tip.

The examination followed a standardized sequence: assessment of oral hygiene status, recording of gingival health, toothbrushing with a disposable toothbrush, drying the teeth with gauze, and subsequent evaluation of dental caries, malocclusion, and traumatic dental injuries.

Keywords
oral health related qualiry of life in preschool children
Medical subject headings
Gingivitis, Malocclusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral Health-Related Quality of Life

    The OHRQoL of preschool children will be assessed using the Early Childhood Oral Health Impact Scale (ECOHIS), included in the parent questionnaire. ECOHIS has 13 items: 9 evaluating the impact of oral problems on the child (Child ECOHIS) and 4 evaluating the impact on the family (Family ECOHIS). The child subscale includes four domains (symptoms, function, psychology, and social interaction), while the family subscale includes parental distress and family function. Items use a Likert scale from 0 ("Never") to 4 ("Very often"), with a "Don't know" option treated as missing. Participants with ≥2 "Don't know" responses in the child subscale or ≥1 in the family subscale will be excluded. The total ECOHIS score ranges from 0-52, with child and family scores ranging from 0-32 and 0-16. Higher scores indicate a more negative impact.

    Assessed at the moment when parents complete the questionnaire.

    Measured: Baseline

Secondary outcomes (5)

  1. Level of Oral Hygiene

    Oral hygiene was assessed using the soft debris component of the Simplified Oral Hygiene Index (OHI-S), following the criteria proposed by Rodrigues. For the primary dentition, the buccal surfaces of teeth 54, 61, and 82 and the lingual surface of tooth 75 were examined with a periodontal probe aligned parallel to the long axis of the tooth. If any of the indicated teeth were missing, the closest distal tooth was examined; if this tooth was also absent, the closest mesial tooth was assessed. Each tooth was assigned an integer score from 0 to 3, and the participant's final score was the mean of the values obtained.

    Assessed during the intraoral examination.

    Measured: Baseline

  2. Gingival health

    Gingival health was quantified using the ORI (Oral Rating Index), an oral classification index, following the criteria proposed by Kawamura. The ORI was based on the examination of four areas: the buccal surfaces of the maxillary anterior teeth, the buccal surfaces of the mandibular anterior teeth, the palatal surfaces of the right maxillary molars, and the lingual surfaces of the right mandibular molars. To determine each individual's ORI level, observable gingival characteristics and the accumulation of calculus and dental plaque were assessed, after which the individual was classified on an ordinal scale. The index was recorded without manual instruments, under natural light, and the decision was made within approximately 10 seconds. In cases of uncertainty, the examiner assigned the lowest score as the representative value for the individual.

    Assessed during the intraoral examination.

    Measured: Baseline

  3. Presence of caries

    For the diagnosis of dental caries, the procedures and criteria of ICDAS II were followed. The protocol described by this system recommended tooth brushing and drying prior to caries detection; therefore, the teeth were brushed with a disposable toothbrush and then dried with gauze. The system used two digits to record each tooth or surface: the first digit referred to restorations and sealants, and the second to the dental caries diagnosis. In this study, recording was performed per tooth, corresponding to the worst condition observed among its surfaces.

    In the ICDAS II system, codes 1 and 2 record early non-cavitated caries. However, because data collection occurred in kindergarten settings without the possibility of drying teeth with compressed air, code 1 for smooth-surface lesions could not be used. As anticipated in ICDAS II guidelines for epidemiological studies, codes 1 and 2 were therefore combined and recorded as "A" in this study.

    Assessed during the intraoral examination.

    Measured: Baseline

  4. Presence of malocclusion

    The criteria for assessing malocclusion followed Bjork, Zhou, and Grippaudo. Malocclusion was classified into three groups: (1) occlusal anomalies (anterior crossbite, edge to edge bite, increased overjet, anterior open bite, deep bite, posterior crossbite, scissor bite); (2) space anomalies (crowding); and (3) dentition anomalies (supernumerary teeth, agenesis, malformations). Anterior crossbite, edge to edge bite, increased overjet, anterior open bite, and deep bite were determined using horizontal and vertical overlap measurements. Horizontal overlap was recorded as the greatest distance between maxillary and mandibular incisors parallel to the occlusal plane; vertical overlap was the greatest distance between their incisal edges.

    Assessed during the intraoral examination.

    Measured: Baseline

  5. Presence of dental trauma

    The criteria used to diagnose traumatic dental injuries were based on WHO recommendations. Teeth affected by dental trauma were coded as follows: 0 - No signs of injury; 1 - Treated injury; 2 - Enamel fracture only; 3 - Enamel and dentine fracture; 4 - Pulp involvement; 5 - Tooth loss due to trauma; 6 - Other damage; 9 - Tooth excluded Assessed during the intraoral examination.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2026
  2. Study start11 Apr 2025
  3. Primary completion20 Mar 2026
  4. Study completion20 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
454 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07648121
Sponsor's protocol ID
CE-FMDUL202519
Status last verified
Apr 2026
First submitted
31 May 2026
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Grippaudo C, Paolantonio EG, Pantanali F, Antonini G, Deli R. Early orthodontic treatment: a new index to assess the risk of malocclusion in primary dentition. Eur J Paediatr Dent. 2014 Dec;15(4):401-6.

    PubMed 25517589

  • Zhou Z, Liu F, Shen S, Shang L, Shang L, Wang X. Prevalence of and factors affecting malocclusion in primary dentition among children in Xi'an, China. BMC Oral Health. 2016 Sep 2;16(1):91. doi: 10.1186/s12903-016-0285-x.

    PubMed 27590299

  • BJOERK A, KREBS A, SOLOW B. A METHOD FOR EPIDEMIOLOGICAL REGISTRATION OF MALOCCLUSION. Acta Odontol Scand. 1964 Feb;22:27-41. doi: 10.3109/00016356408993963. No abstract available.

    PubMed 14158468

  • Dikmen B. Icdas II criteria (international caries detection and assessment system). J Istanb Univ Fac Dent. 2015 Oct 21;49(3):63-72. doi: 10.17096/jiufd.38691. eCollection 2015.

    PubMed 28955548

  • Kawamura M, Aoyama H, Sasahara H, Tsuchida K, Nagao M, Iwamoto Y. [Behavioral dental science. Part VIII. The dentist's rating and adolescents' perceptions of oral health]. Nihon Shishubyo Gakkai Kaishi. 1988 Dec;30(4):1097-107. doi: 10.2329/perio.30.1097. Japanese.

    PubMed 3270660

  • Rodrigues CR, Ando T, Guimaraes LO. [Simplified oral hygiene index for ages 4 to 6 and 7 to 10 (deciduous and mixed dentition)]. Rev Odontol Univ Sao Paulo. 1990 Jan-Mar;4(1):20-4. Portuguese.

    PubMed 2135326

  • 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

Questions about this trial

What is this clinical trial studying?

An observational study of Oral Health Related Quality of Life (OHRQoL) and Early Childhood Caries (ECC), run by University of Lisbon 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 4 inclusion and 1 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 16 Jun 2026. 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?

Oral Health-Related Quality of Life (time frame: Baseline). 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 NCT07648121, which also lists 7 linked publications.

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 16 Jun 2026.

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