Pregnancy RelatedNCT01675180
Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women
A study testing Information in people with Pregnancy Related and Oral Health, run by University of Tromso at 1 site in Norway.
Trial summary
Purpose/Objective of the study: The main objective of the study is to investigate oral health awareness and attitudes towards oral health among Norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy. The hypothesis of the study are: 1. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Oral Health, Attitude
- What is being tested?
- Information
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2013to Oct 2022
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with viable pregnancy ≥ 17 weeks gestation
Who cannot join
- Those not willing to participate in the study.
- Women who are unable to communicate well in Norwegian.
- Women who have been diagnosed to have a fetus with a chromosomal or structural fetal anomaly and do not plan to continue their pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN)
Tromsø, Troms, 9037
About this study
Official title: Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway
Purpose/Objective of the study:
The main objective of the study is to investigate oral health awareness and attitudes towards oral health among Norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy.
Read more
The hypothesis of the study are:
- The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
- Pregnant women with high level of oral health awareness and positive attitude towards oral health are more likely to visit their dentists regularly and have better oral hygiene compared to those with less awareness.
- Proper information and guidance on oral hygiene care provided during pregnancy can help to improve oral bacteriological milieu and reduce the dental caries risk among pregnant women.
- Conditions
- Pregnancy Related, Oral Health, Attitude, Oxidative Stress
- Being tested
- Information, Control
- Keywords
- pregnancy, Streptococcus mutans, Lactobacillus, Oxidative stress
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
Women in the intervention group will receive information and counseling on oral health care during pregnancy
ControlOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Information | Other | Women randomized to the intervention will receive information and counseling on oral health care during pregnancy Receives: Other: Information; Other: Control |
| Control | No intervention | Women in non-intervention arm receive usual routine ante-natal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health
Streptococcus Mutans, lactobacilli
Measured: In 4 weeks interval after recrutiatment of study participants
Secondary outcomes (1)
Attitude
Attitude towards oral health care
Measured: After approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startFeb 2013
- Primary completionMar 2020
- Study completionOct 2022
Why it stopped: The RCT part of the study was stopped due to futility in March 2020 as we were able to recruite and randomize only 97 participants since the study started. The observational part of the study stopped on 09.10.2022 as the ethics approval expired.
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 Pregnancy RelatedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway
- Responsible party
- Sponsor
- Investigators
- Ganesh Acharya, Professor, Principal investigator, University of Tromsø and University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675180
- Sponsor's protocol ID
- 19353(2012/633/REK nord)
- Status last verified
- Sep 2019
- First submitted
- 27 Aug 2012
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Wagle M, D'Antonio F, Reierth E, Basnet P, Trovik TA, Orsini G, Manzoli L, Acharya G. Dental caries and preterm birth: a systematic review and meta-analysis. BMJ Open. 2018 Mar 2;8(3):e018556. doi: 10.1136/bmjopen-2017-018556.
PubMed 29500202
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway
- ClinicalTrials.gov ID
- NCT01675180
- Acronym / sponsor ID
- 19353(2012/633/REK nord)
- Conditions
- Pregnancy Related, Oral Health, Attitude, Oxidative Stress
- Keywords
- pregnancy, Streptococcus mutans, Lactobacillus, Oxidative stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The RCT part of the study was stopped due to futility in March 2020 as we were able to recruite and randomize only 97 participants since the study started. The observational part of the study stopped on 09.10.2022 as the ethics approval expired.
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- University Hospital of North Norway
- Study start
- Feb 2013
- Primary completion
- Mar 2020 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 29 Aug 2012 (estimated)
- 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.
Purpose/Objective of the study:
The main objective of the study is to investigate oral health awareness and attitudes towards oral health among Norwegian pregnant women and assess the impact of information about oral hygiene on the risk of dental caries during pregnancy.
The hypothesis of the study are:
- The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
- Pregnant women with high level of oral health awareness and positive attitude towards oral health are more likely to visit their dentists regularly and have better oral hygiene compared to those with less awareness.
- Proper information and guidance on oral hygiene care provided during pregnancy can help to improve oral bacteriological milieu and reduce the dental caries risk among pregnant women.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information | Other | Other: Information, Other: ControlWomen randomized to the intervention will receive information and counseling on oral health care during pregnancy |
| Control | No intervention | –Women in non-intervention arm receive usual routine ante-natal care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with viable pregnancy ≥ 17 weeks gestation
Key exclusion criteria (3 listed)
- Those not willing to participate in the study.
- Women who are unable to communicate well in Norwegian.
- Women who have been diagnosed to have a fetus with a chromosomal or structural fetal anomaly and do not plan to continue their pregnancy
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 |
|---|---|---|
| InformationWomen in the intervention group will receive information and counseling on oral health care during pregnancy | Other | Information |
| ControlNo intervention | Other | Information |
Primary outcome
Oral health
Time frame: In 4 weeks interval after recrutiatment of study participants
Streptococcus Mutans, lactobacilli
1 secondary outcome
Attitude
Time frame: After approximately 6 months
Results and safety
The study was stopped early (reason given: The RCT part of the study was stopped due to futility in March 2020 as we were able to recruite and randomize only 97 participants since the study started. The observational part of the study stopped on 09.10.2022 as the ethics approval expired.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 29500202Wagle M, D'Antonio F, Reierth E, Basnet P, Trovik TA, Orsini G, Manzoli L, Acharya G. Dental caries and preterm birth: a systematic review and meta-analysis. BMJ Open. 2018 Mar 2;8(3):e018556. doi: 10.1136/bmjopen-2017-018556.
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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.
Ganesh Acharya, Professor principal investigator
University of Tromsø and University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with Pregnancy Related and Oral Health, run by University of Tromso at 1 site in Norway.
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 1 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: stopped early, as of the sponsor's last update on 12 Mar 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 Norway. 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 was stopped early (reason given: The RCT part of the study was stopped due to futility in March 2020 as we were able to recruite and randomize only 97 participants since the study started. The observational part of the study stopped on 09.10.2022 as the ethics approval expired.). Results are not available in the source record.
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 (time frame: In 4 weeks interval after recrutiatment of study participants). 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 NCT01675180, 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 12 Mar 2026.