Piloting of a Midwife Initiated Oral Health-Dental Service (MIOH-DS) to improve the oral health of pregnant women

Recruitment status:
Not recruiting
Primary Sponsor:
Other Collaborative groups Centre for Applied Nursing Research- Sydney South West Area Health Service/ University of Western Sydney
Recruitment countries:
Australia
Health condition studied:
Oral health status
URL:
Link to the clinical trial website

About the trial

Interventions:
Intervention group 1: Midwifery intervention (Oral health education, assessment and referrals to dental services). This group will receive oral health promotional material at the time of recruitment. This group will also receive a midwifery intervention which will involve midwives providing the following at the 1st antenatal visit:

Oral Health education: Midwives will emphasise the importance of oral health during pregnancy and provide information about oral hygiene instructions and dietary counselling.
Brief oral assessment: As part of the antenatal check up, midwives (trained in oral assessment) will conduct brief oral assessments of pregnant women using an oral assessment tool and if required, conduct a visual examination of the oral cavity to confirm any concerns. Prior to the trial all midwives will be required to complete an online educational program and assessment exercise to ensure that they have adequate knowledge about oral health care and are competent to conduct oral assessments.

Referrals: In this group, all pregnant women assessed to have a dental problem will be referred to existing dental services (either private, public or health fund) for treatment.

The midwifery intervention (involving oral health education assessment and referral) will be of 5-8 minutes duration and will be conducted once at the first antenatal appointment

Intervention group 2: : Midwifery Intervention (as in Intervention group 1) and Dental Intervention (Oral health assessment and treatment by a Dentist at a free dental service). This group will receive oral health promotional material at the time of recruitment. This group will also receive a midwifery and dental intervention. The midwifery intervention will be similar to Intervention group 2. However, in this group all pregnant women, regardless of whether they are assessed to have a dental problem or not by the midwife, will be referred to a dentist for a detailed pre-oral assessment. This is to allow further validation of the oral assessment tool and to gather baseline data on oral health. Further, pregnant women who consent will be provided with vouchers that will entitle them to priority access to free dental assessment and treatment at dental clinics in Sydney South West Area Health Service. This service will be an extra service created in SSWAHS specifically for this study. The dental vouchers will be valid for 4 weeks from the date of booking visit to encourage pregnant women to see the dentist at the earliest time.

Dental intervention: At the first dental appointment all the women will undergo detailed pre-oral assessment that will include medical history, followed by oral mucosal tissue examination, periodontal examination, dental caries examination and denture evaluation. A provisional diagnosis and treatment plan will be made for those women having oral health problems. Once the consent for treatment is obtained, subsequent appointments will be made in the second trimester to complete all the urgent treatment for women having dental problems. Second semester (13-27 weeks) is considered a safe period to carry out necessary dental treatment. The completion of treatment will take 1 to 3 additional visits depending on the treatment plan. Women having complex treatment needs such as root canal treatment will be referred to the specialist for follow up care and will be excluded from the study. After each examination the participants will be provided oral health education including oral hygiene instructions, brushing and flossing instructions and dietary counselling.

The dental intervention will be provided by two dentists employed for the study. Prior to the trial the dentists will participate in a two hour education workshop. At the workshop, the standardized dental care protocol to follow during pregnancy will be discussed. In addition, training will be provided on the use of the oral health status measures and 10 mock oral assessments will also be conducted to assess their inter-rater reliability. As mentioned above the dental intervention will involve an initial pre-oral assessment followed by 1- 3 dental visits depending on the treatment plan. Each dental visit will be of maximum one hour duration.

All women in the study including those in the control group, intervention group 1 and group 2 (with or without oral health problems) will undergo a final post-oral examination by a dentist at 28-42 week gestation period. This exam will be similar to the initial oral examination and will include a detailed clinical assessment. A post test questionnaire will also be administered to all women at this time. Pregnant women in the control group identified to have a dental problem will be referred to dental services after pregnancy.
Key inclusion and exclusion criteria:
  • Inclusion criteria: -More than 16 years of age;
    -Do not have cardiac disease that would warrant the need of antibiotics for dental treatment;
    - Have not received dental treatment in the current pregnancy
    - Have a single pregnancy of more than 12 and less than 20 weeks of gestational age;
    - Do not have any known foetal anomalies or other risk factors that would place the pregnancy at risk of complications;
    - Are able to attend regularly for dental treatment if required.
  • Exclusion criteria: - Have cardiac disease that would warrant the need of
    antibiotics for dental treatment;
    - Have received dental treatment in the current pregnancy
    - More than 20 weeks of gestational age;
    - Multiple pregnancy;
    - Have known foetal anomalies or other risk factors that
    would place the pregnancy at risk of complications;
    - Unable to attend regularly for dental treatment if required.
  • Age minimum:  16 Years
  • Age maximum:  0 No limit
  • Gender:  Females
Primary outcomes:
Oral health status- assessed by using the following oral health measures: gingival index, clinical attachment loss, plaque index and dental caries
Specificity and sensitivity of midwifery oral assessment- assessed by validating the midwife oral assessment tool against the gold standard (initial pre oral assessment conducted by the dentists in Intervention group 2)
Uptake of dental services
Secondary outcomes:
Oral Health Knowledge- assessed using a pre-test and post-test questionnaire at the recruitment and post oral assessment period respectively.
Quality of oral health- assessed using a validated item in the pre and post-test questionnaire
Target sample size:
489
Study type:
Interventional
Study design:
Contacts:
  • Name:  Dr Dr Ajesh George
  • Address:  Centre for Applied Nursing Research Locked Bag 7103 Liverpool BC NSW 1871, Australia
  • Phone:  +61287389356
  • Email:  ajesh.george@sswahs.nsw.gov.au
  • Affiliation: 

Technical details

Scientific title:
In pregnant women how effective is a midwifery intervention (involving oral health education, assessment and referrals to dental clinics) compared with no midwifery intervention in improving women’s oral health status, uptake of dental services, oral health knowledge and quality of oral health.
Sources of monetary support:
Australian Dental Association (NSW Branch)
The NSW Centre for Oral Health Strategy
University of Western Sydney
Secondary sponsors:
School of Nursing and Midwifery- University of Western Sydney
Main ID:
ACTRN12610000794000
Secondary ID:
Nil
Register:
ANZCTR
Date of registration:
24/09/2010
Date of first enrollment:
15/10/2010
Last refreshed:
2 December 2013

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