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

NCT01675180 | Terminated

• 1 other identifier: 19353(2012/633/REK nord)
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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:

1. 1.The state of oral health during pregnancy depends on pregnant woman's preventive oral hygiene behaviour and practice.
2. 2.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.
3. 3.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

Oral Health; Attitude; Oxidative Stress; Pregnancy Related

Keywords

pregnancy; Streptococcus mutans; Lactobacillus; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• Oral health

  Streptococcus Mutans, lactobacilli

  In 4 weeks interval after recrutiatment of study participants

Secondary Outcomes (1)

• Attitude

  After approximately 6 months

Study Arms (2)

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

Information OTHER

Women in the intervention group will receive information and counseling on oral health care during pregnancy

Information

Control OTHER

No intervention

Information

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with viable pregnancy ≥ 17 weeks gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator

Study Sites (1)

Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN)

Tromsø, Troms, 9037, Norway

Location

Related Publications (1)

• 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.

  PMID: 29500202 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Ganesh Acharya, Professor

  University of Tromsø and University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2012
• First Posted: August 29, 2012
• Study Start: February 1, 2013
• Primary Completion: March 1, 2020
• Study Completion: October 1, 2022
• Last Updated: March 12, 2026

Record last verified: 2019-09

Locations

NO (1)