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Trial registered on ANZCTR


Registration number
ACTRN12610000794000
Ethics application status
Approved
Date submitted
21/09/2010
Date registered
24/09/2010
Date last updated
27/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting of a Midwife Initiated Oral Health-Dental Service (MIOH-DS) to improve the oral health of pregnant women
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.
Secondary ID [1] 252729 0
Nil
Secondary ID [2] 283656 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health status 258225 0
Condition category
Condition code
Public Health 258404 258404 0 0
Health service research
Public Health 258405 258405 0 0
Health promotion/education
Reproductive Health and Childbirth 258406 258406 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257243 0
Early detection / Screening
Intervention code [2] 257244 0
Prevention
Intervention code [3] 257245 0
Behaviour
Comparator / control treatment
Control group: No Midwifery or Dental Intervention (current practice). This group will receive oral health promotional material at the time of recruitment. They will not receive any intervention from midwives or dentists until the completion of the trial. At the point of completion, these women will be referred to dental services, if required. In current practice, at the first antenatal appointment midwives undertake a complete health assessment of pregnant women. However, no oral assessment is done at this time.
Control group
Active

Outcomes
Primary outcome [1] 259243 0
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)
Timepoint [1] 259243 0
This outcome will be assessed when the dentists (employed for this study) conduct the pre oral assessment of pregnant women in Intervention group 2 (IG2). The pre oral assessment will be done in the second trimester (13-27 weeks gestation or 1- 7 weeks after randomisation) as this is the saftest period to undertake dental procedures. The dental vouchers provided to the pregnant women in IG2 will have 4 weeks validity to ensure that they see the dentists at the earliest. The exact timepoint for this outcome will be determined when the pre oral assessment is conducted.
Primary outcome [2] 259247 0
Uptake of dental services
Timepoint [2] 259247 0
This outcome will be assessed by collecting data from the following sources:
-post questionnaire: The post questionnaire will be administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation).

- the returned checklist of the voucher: The voucher will contain information about interventions covered and a detachable checklist of treatments conducted and date of service delivery, to be completed by the dentists and returned to the investigators. The checklist will help assess the uptake of dental services.

- the database of the dental clinics
- following up all referrals at the post oral assessment period and during subsequent antenatal visits.
Primary outcome [3] 259248 0
Oral health status- assessed by using the following oral health measures: gingival index, clinical attachment loss, plaque index and dental caries
Timepoint [3] 259248 0
The oral health status will be assessed by comparing data (collected by the dentists employed for this study) from the pre oral assessment (done during 13-27 weeks gestation or 1- 7 weeks after randomisation) and post oral assessment (done during 28-42 weeks gestation period or within 16-22 weeks after randomisation).
Secondary outcome [1] 265653 0
Oral Health Knowledge- assessed using a pre-test and post-test questionnaire at the recruitment and post oral assessment period respectively.
Timepoint [1] 265653 0
Oral health knowledge will be assessed by comparing data from a pre test questionaire (administered to all participants at the time of recruitment (12- 20 weeks gestation) and a post-test questionnaire (administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation).
Secondary outcome [2] 265654 0
Quality of oral health- assessed using a validated item in the pre and post-test questionnaire
Timepoint [2] 265654 0
Quality of oral health will be assessed by comparing data from a pre test questionaire (administered to all participants at the time of recruitment (12- 20 weeks gestation) and a post-test questionnaire (administered to all participants at 28-42 weeks gestation period (within 16-22 weeks after randomisation).

Eligibility
Key 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.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pregnant women will be recruited from an antenatal clinic at a large metropolitan hospital in Southwest Sydney. Information about the study will be provided to all pregnant women attending their first antenatal visit (booking visit). At all antenatal clinics the first booking visit is seen by midwives. While waiting to see the midwife, pregnant women will be invited to participate by an independent recruiter, blind to group allocation. This recruitment process aims to help reduce selection bias. Informed written consent will be obtained by the dental assistant from pregnant women who meet the study criteria. Pregnant women will be allocated to the groups using block randomisation with blocks of six. A computer generated random number sequence will be used to choose the blocks and set the allocation order of the participants. Block randomisation will ensure that the number of participants in each arm of the trial will be evenly balanced. Group allocation will be represented by coloured stickers concealed in serially numbered opaque envelopes. After assessing the eligibility of the participants, obtaining consent and collecting baseline data, the dental assistant will open the envelope and place the coloured sticker on the patient file which will be given to the midwife. All midwives at the pilot site will be aware what each coloured sticker represents. To maintain allocation concealment the dental assistant will be unaware which group each coloured sticker represents and the block size used for randomisation. This will help minimise selection bias. In addition, the study investigators will be blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pregnant women will be allocated to the groups using block randomisation. A computer generated random number sequence will be used to choose the blocks and set the allocation order of the participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2010
Actual
13/05/2011
Date of last participant enrolment
Anticipated
Actual
24/10/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
489
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257685 0
University
Name [1] 257685 0
University of Western Sydney
Country [1] 257685 0
Australia
Funding source category [2] 257686 0
Government body
Name [2] 257686 0
The NSW Centre for Oral Health Strategy
Country [2] 257686 0
Australia
Funding source category [3] 257687 0
Charities/Societies/Foundations
Name [3] 257687 0
Australian Dental Association (NSW Branch)
Country [3] 257687 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Applied Nursing Research- Sydney South West Area Health Service/ University of Western Sydney
Address
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 256901 0
University
Name [1] 256901 0
School of Nursing and Midwifery- University of Western Sydney
Address [1] 256901 0
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country [1] 256901 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259717 0
Sydney South West Area Health Service Human Research Ethics Committee (Western Zone)
Ethics committee address [1] 259717 0
Ethics committee country [1] 259717 0
Australia
Date submitted for ethics approval [1] 259717 0
03/05/2010
Approval date [1] 259717 0
11/08/2010
Ethics approval number [1] 259717 0
2010/049

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31669 0
Dr Ajesh George
Address 31669 0
Centre for Applied Nursing Research
Locked Bag 7103 Liverpool BC NSW 1871
Country 31669 0
Australia
Phone 31669 0
+61287389356
Fax 31669 0
Email 31669 0
ajesh.george@sswahs.nsw.gov.au
Contact person for public queries
Name 14916 0
Dr Ajesh George
Address 14916 0
Centre for Applied Nursing Research Locked Bag 7103 Liverpool BC NSW 1871
Country 14916 0
Australia
Phone 14916 0
+61287389356
Fax 14916 0
Email 14916 0
ajesh.george@sswahs.nsw.gov.au
Contact person for scientific queries
Name 5844 0
Dr Ajesh George
Address 5844 0
Centre for Applied Nursing Research Locked Bag 7103 Liverpool BC NSW 1871
Country 5844 0
Australia
Phone 5844 0
+61287389356
Fax 5844 0
Email 5844 0
ajesh.george@sswahs.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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