Condition category
Oral Health
Date applied
01/06/2016
Date assigned
09/06/2016
Last edited
09/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dental caries (tooth decay leading to holes in the teeth) and periodontal (gum) diseases are two of the most common diseases of the mouth (oral disease). Studies on how they occur help in preparing programs to prevent them. This study looks at the oral health of people living in the West Pomeranian region in Poland investigating, for example, why they may come to a dental surgery for treatment, how often they go to the dentist, how they brush their teeth, if they have a fear of going to the dentist and what their opinion is of dental services in general.

Who can participate?
Adults (aged at least 18) living in the West Pomeranian region in Poland.

What does the study involve?
All participants are asked to fill in a questionnaire. The questionnaire comes in two parts. The first part contains questions on personal data, such as the participants gender, age, where they live, level of education and how much each person earns in their household. The second part contains questions on how they use dental services, how often they go to the dentist, reasons for going or delaying going to see a dentist, if they fear going to the dentist, and their oral hygiene habits (how often do they clean their teeth, for example, how often do they replace their toothbrush and what dental products do they use). The questionnaire also has questions regarding the participants opinions on the services given. Each participant also has a dental check-up, and have short interview about how they themselves see their general health.

What are the possible benefits and risks of participating?
Benefits include the patients gaining knowledge on their oral health and possible solutions to various dental problems. There are no risks involved.

Where is the study run from?
Healthcare Centre Denticus 2, Szczecin (Poland)

When is the study starting and how long is it expected to run for?
March 2011 to March 2014

Who is funding the study?
Healthcare Centre Denticus 2, Szczecin (Poland)

Who is the main contact?
Dr Jolanta Świderska

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jolanta Świderska

ORCID ID

Contact details

Bolesława Śmiałego 28
Szczecin
70-348
Poland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Conditionings of oral health status in adult patients, analysis of chosen factors influensing dental attendance and health attitutes in the range of oral health maintanance

Acronym

Study hypothesis

Oral health status is influenced by socioeconomic factors

Ethics approval

Ethics Committee of the Regional Medical Council in Szczecin, 30/03/2011, ref: 04/KB/IV/2011

Study design

Observational and clinical study of oral health and related health behaviours

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

GP practices

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Dental caries, periodontal diseases

Intervention

This study was conducted in private dental facilities in the city of Szczecin, Poland, on 301 randomly chosen patients undergoing dental treatment.

The patients were asked to fill a self-administered questionnaire and were examined by dental professionals. The questionnaire consisted of two major parts. First part contained questions related to patients’ personal data including gender, age, place of residence, education and income per person in a household. The second part consisted of questions related to the utilization of dental services, dental attendance, reasons of attending and delaying visits, fear of the dentist and hygiene habits (i.e. frequency of brushing teeth and replacing toothbrush, use of dental products). It also consisted of questions regarding patients’ opinion on the range of services covered by the public insurance and opinion on the provided services. Overall there were 24 questions, providing an insight on patients’ socio-economic status and dental habits.

Clinical examination was performed in the dental environment, in artificial light, with use of mirror and dental probe in accordance with World Health Organization (WHO) recommendation. The examination was preceded with a short interview, to determine patients’ evaluation of their health (cardiovascular diseases, metabolic disorder, blood diseases, infectious diseases, smoking habits). Results were added to the results acquired from the dental data sheet of own design.

Intervention type

Phase

Drug names

Primary outcome measures

1. Experience of dental caries, measured by number of decayed, missing and filled teeth during clinical examination
2. Periodontal health measured by the occurence of calculus, bleeding, pockets and excluded sextants during clinical examination

Secondary outcome measures

Dental related behaviour - assessed by dental attendance, brushing habits, dental fear and opinion on dental services measured with questionnaire before the clinical examination.

Overall trial start date

30/03/2011

Overall trial end date

30/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: at least 18
2. Women and Men
3. Income: all ranges
4. Place of living: all ranges
5. Education: primary, secondary, vocational, higher

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

301

Participant exclusion criteria

Participants under 18 years of age

Recruitment start date

10/04/2011

Recruitment end date

10/04/2012

Locations

Countries of recruitment

Poland

Trial participating centre

Healthcare Centre Denticus 2
Szczecin
70-348
Poland

Sponsor information

Organisation

Healthcare Centre Denticus 2

Sponsor details

Bolesława Śmiałego 28
Szczecin
70-348
Poland

Sponsor type

Other

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Healthcare Centre Denticus 2

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date.

Intention to publish date

08/06/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes