Self Reported Oral Health, Awareness and Attitude Towards... | NCT01675180

Studies
Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women

NCT01675180

Sponsor

University of Tromso

Status

Terminated

Last Update Posted

Mar 12, 2026Actual

Enrollment

97Actual

Phase

Not Applicable

Conditions

Pregnancy Related
Oral Health
Attitude
Oxidative Stress

Interventions

Information
Control

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Mar 2020Actual

Completion Date

Oct 2022Actual

First Submitted Date

Aug 27, 2012

First Submission Date that Met QC Criteria

Aug 27, 2012

First Posted Date

Aug 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Name	Class
University Hospital of North Norway	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Information	Other	Women randomized to the intervention will receive information and counseling on oral health care during pregnancy	Other: Information Other: Control
Control	No Intervention	Women in non-intervention arm receive usual routine ante-natal care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Information	Other	Women in the intervention group will receive information and counseling on oral health care during pregnancy	Information

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oral health	Streptococcus Mutans, lactobacilli	In 4 weeks interval after recrutiatment of study participants

Secondary Outcomes

Measure	Description	Time Frame
Attitude	Attitude towards oral health care	After approximately 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with viable pregnancy ≥ 17 weeks gestation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ganesh Acharya, Professor	University of Tromsø and University Hospital of North Norway	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN)		Tromsø	Troms	9037	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29500202	Derived	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.