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Trial registered on ANZCTR


Registration number
ACTRN12618001543279
Ethics application status
Approved
Date submitted
10/09/2018
Date registered
14/09/2018
Date last updated
14/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Periodontal treatment prevent the occurrence of Preeclampsia and Still Birth in Pregnant women?
Scientific title
Does periodontal treatment affect the incidence of Preeclampsia and Still Birth in pregnant women. A single blinded, parallel arm, Randomized Controlled Trial.
Secondary ID [1] 295496 0
None
Universal Trial Number (UTN)
U1111-1217-3629
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 308768 0
Still birth 308769 0
Condition category
Condition code
Reproductive Health and Childbirth 307702 307702 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 307703 307703 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be two groups of pregnant females,a total of 100 participants, who fulfill the inclusion criteria. The 'experimental' group (n = 50) will first be provided with oral health education. This would include detailed instructions on how and when to brush their teeth. The instructions would be given orally with tooth brushing demonstration provided on a dental teeth model. Thereafter, the participants of the 'experimental' group will be receiving the periodontal treatment including oral hygiene instructions and a non surgical scaling and polishing of the teeth,with the help of ultrasonic scaler tips and ultrasonic brushes respectively. As an incentive, the participants of the 'experimental group' will also be provided with a free tooth brush and a toothpaste. Once the treatment is provided, a dental checkup will be performed after 12 weeks of the treatment to evaluate the periodontal health status of the patients. The dental checkup would include an assessment of the periodontal status of the patient using the British Periodontal Examination (BPE) index. This is a validated and reliable instrument for the purpose of measuring the periodontal status of individuals.The Prophylactic treatment will be provided one time initially but if the patient requires further treatment at the followup,it must be provided. Other than periodontal treatment, the participants of both groups would be provided with necessary oral health care e.g restorations, endodontic treatment, if required, and this being assessed through complete oral examination, DMFT charting that will carried out at the initial assessment of the patient. The treatment will be provided by the house officers,in the supervision of trained dentists in the periodontology department of Fauji Foundation Hospital, Rawalpindi.
a dental checkup will be performed after 12 weeks of the treatment to evaluate the periodontal health status of the patients. The dental checkup would include an assessment of the periodontal status of the patient using the British Periodontal Examination (BPE) index. This is a validated and reliable instrument for the purpose of measuring the periodontal status of individuals.The Prophylactic treatment will be provided one time initially but if the patient requires further treatment at the followup,it must be provided. Other than periodontal treatment, the participants of both groups would be provided with necessary oral health care e.g restorations, endodontic treatment, if required, and this being assessed through complete oral examination, DMFT charting that will carried out at the initial assessment of the patient. The treatment will be provided by the house officers,in the supervision of trained dentists in the periodontology department of Fauji Foundation Hospital, Rawalpindi.
At the 12 weeks checkup, the blood pressure of the patient would be measured using a mercurial sphygmomanometer and urine analysis will be done to check for proteinurea. This analysis will be done to assess the preeclampsia status of the patients.
Intervention code [1] 301821 0
Treatment: Other
Comparator / control treatment
Oral health education will be provided to the 'control' group (n = 50) as well. This would include detailed instructions on how and when to brush their teeth. The instructions would be provided orally with tooth brushing demonstrated on a dental teeth model. As an incentive, the participants of the control group will also be provided with a free tooth brush and a toothpaste. A dental checkup will be performed after 12 weeks to evaluate the periodontal health status of the patients. The dental checkup would include an assessment of the periodontal status of the patient using the British Periodontal Examination (BPE) index. This is a validated and reliable instrument for the purpose of measuring the periodontal status of individuals.The Prophylactic treatment will be provided one time initially but if the patient requires further treatment at the followup,it must be provided. Other than periodontal treatment, the participants of both groups would be provided with necessary oral health care e.g restorations, endodontic treatment, if required, and this being assessed through complete oral examination, DMFT charting that will carried out at the initial assessment of the patient. The treatment will be provided by the house officers,in the supervision of trained dentists in the periodontology department of Fauji Foundation Hospital, Rawalpindi.
At the 12 weeks checkup, the blood pressure of the patient would be measured using a mercurial sphygmomanometer and urine analysis will be done to check for proteinurea. This analysis will be done to assess the preeclampsia status of the patients.
Control group
Active

Outcomes
Primary outcome [1] 306715 0
Preeclampsia: Preeclampsia is a pregnancy specific, multisystem syndrome characterised by reduced organ perfusion secondary to vasospasm and activation of the coagulation cascade. A patient is characterized as having preeclampsia if her blood pressure is greater than 140/90 mm Hg and/or she has 1 + proteinurea on a catherized urine specimen.
A Urine Renal Examination (RE) examination and blood pressure measurement using a Mercurial sphygmomanometer will be done to assess the preeclampsia status of the patients at follow up appointment (12 weeks after the first appointment).
Timepoint [1] 306715 0
Usually after 20 week of pregnancy

The patient will be assessed for preeclampsia according to the following timeline:
1. First appointment: This is the appointment where the patient will be recruited. This would be her first visit to the gynecology department (provided that the first visit is within the first 18 weeks of her pregnancy).
2. Second appointment (follow-up): This would be the first follow up appointment. This assessment would be done 12 weeks after the first appointment of the patient.
3. Third appointment (Delivery): This would be second follow up appointment. This would be done at the delivery appointment. The assessment of the patient would be done 6 hour after the delivery.
Primary outcome [2] 306716 0
Still Birth: Still birth is defined as a baby born with no signs of life at or after 28 weeks of gestation. Fetal monitoring is conducted to assess for still birth. No fetal movement is an indicator for still birth.
Still birth will be assessed at the first follow up (12 weeks after the first appointment) and the second follow up (at the time of delivery).
Timepoint [2] 306716 0
At or after 28 weeks of pregnancy

The patient will be assessed for stillbirth according to the following timeline:
1. First appointment: This is the appointment where the patient will be recruited. This would be her first visit to the gynecology department (provided that the first visit is within the first 18 weeks of her pregnancy).
2. Second appointment (follow-up): This would be the first follow up appointment. This assessment would be done 12 weeks after the first appointment of the patient.
3. Third appointment (Delivery): This would be second follow up appointment. This would be done at the delivery appointment. The assessment of the patient would be done 6 hour after the delivery.
Secondary outcome [1] 351823 0
Nil
Timepoint [1] 351823 0
Nil

Eligibility
Key inclusion criteria
Maternal Age(18-45 years)
Gestational Age (3rd trimester of pregnancy)
Normal BLood pressure Range (120/80 mmHg)
No Periodontal therapy within 6 months before pregnancy
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Gingivitis,Periodontitis
History of smoking
Body Mass Index (BMI),is out of range (BMI is 30 or Higher)
History of Hypertensive disorders
History of previous premature births or any of the adverse pregnancy outcomes
Metabolic Disorders(Diabetes,Renal disorders etc)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be concealed. Pregnant women who fulfill the selection criteria for the trial will be allotted unique code numbers to either the intervention group (Group A) or the control group (Group B) by using the following method:
The code numbers will be allocated their respective groups by random computer generated sequencing. These unique code numbers will be written on papers and sealed in envelopes. All envelopes will be placed in a basket. A random person (a ward nurse) will be requested to select an envelope for each participant and the group will be allocated their respective Group (A or B) according to the allocation sequence decided according to the computer generated allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Initially the two groups will be decided by random computer generated sequencing.
Then the code numbers of the two groups will be written on small pieces of paper, which will be folded and put into separate envelopes. These envelopes will be kept in a basket. A random person (a ward nurse) will be requested to select an envelope for each patient that fits into the selection criteria for the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Two individuals will be assessing the outcomes in both groups.
The persons assessing the outcomes will not be aware of the allocation of the participants.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main outcome variables are preeclampsia and still birth. The patients will be labelled as 'present' and absent', as according to the incidence of the outcome.
Therefore, both outcome variables will be categorical.
Chi-squared test will be applied to assess if there is any difference in the occurrence of preeclampsia and still birth between the intervention and control groups.
Relative risk with 95% confidence intervals will be calculated to assess the risk of occurrence of preeclampsia and still birth in women who receive prophylactic periodontal treatment during their first trimester, in comparison to those women who do not receive any treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/09/2018
Actual
Date of last participant enrolment
Anticipated
4/12/2018
Actual
Date of last data collection
Anticipated
4/06/2019
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 10661 0
Pakistan
State/province [1] 10661 0
Federal Capital Territory

Funding & Sponsors
Funding source category [1] 300082 0
University
Name [1] 300082 0
Riphah International University
Country [1] 300082 0
Pakistan
Primary sponsor type
University
Name
Riphah International University
Address
Islamic International Dental College,Riphah International University,7th avenue,G-7/4 Islamabad
Country
Pakistan
Secondary sponsor category [1] 299481 0
None
Name [1] 299481 0
Address [1] 299481 0
Country [1] 299481 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300929 0
Institutional Review Committee, Islamic International Dental College
Ethics committee address [1] 300929 0
Institutional Review Committee, Department of Community Dentistry, Islamic International Dental College, Riphah International University, 7th Avenue, G-7/4, Islamabad
Ethics committee country [1] 300929 0
Pakistan
Date submitted for ethics approval [1] 300929 0
30/06/2018
Approval date [1] 300929 0
18/07/2018
Ethics approval number [1] 300929 0
IIDC/IRC/2018/07/002

Summary
Brief summary
Periodontal disease is an inflammatory condition of the supporting tissues of the teeth that may affect the gum tissues involving periodontal ligament, cementum and might involving the bone. Several studies have suggested an association between the periodontal disease and pregnancy complications which can lead to the adverse pregnancy outcomes, such as Still birth, Preeclampsia, preterm delivery and low fetal birth weight, jeopardizing the lives of both the mother and the fetus. To determine if periodontal therapy works to reduce these adverse pregnancy outcomes, high quality randomized controlled trials are required. In this study we will try to assess the impact of prophylactic periodontal treatment in preventing the occurrence of preeclampsia and still birth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85314 0
A/Prof Muhammad Humza Bin Saeed
Address 85314 0
Department of Community Dentistry, Islamic International Dental College, Riphah International University, Service Road,7th Avenue, G-7/4, Islamabad
Country 85314 0
Pakistan
Phone 85314 0
0092512891835
Fax 85314 0
Email 85314 0
[email protected]
Contact person for public queries
Name 85315 0
Muhammad Humza Bin Saeed
Address 85315 0
Department of Community Dentistry, Islamic International Dental College, Riphah International University, Service Road,7th Avenue, G-7/4, Islamabad
Country 85315 0
Pakistan
Phone 85315 0
0092512891835
Fax 85315 0
Email 85315 0
[email protected]
Contact person for scientific queries
Name 85316 0
Muhammad Humza Bin Saeed
Address 85316 0
Department of Community Dentistry, Islamic International Dental College, Riphah International University,Service Road, 7th Avenue, G-7/4, Islamabad
Country 85316 0
Pakistan
Phone 85316 0
0092512891835
Fax 85316 0
Email 85316 0
[email protected]

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