Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes
Primary Purpose
Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scaling and root planning
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Disease focused on measuring periodontal disease, pregnancy, periodontal treatment
Eligibility Criteria
Inclusion Criteria:
- confirmed singleton gestations
- pregnancy of 9-24
- systemically healthy women
- age range: 16-39 years old
Exclusion Criteria:
- non confirmed pregnancy
- age inferior to 16 years or superior to 39 years
- multiple gestations
- smoking
- alcohol or drugs abuse
- history of congenital heart disease
- current use of corticosteroids or antibiotics
- presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)
Sites / Locations
- Jardim Redentor I Public Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Periodontal treatment
Control
Arm Description
Scaling and root planning
Outcomes
Primary Outcome Measures
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight
Secondary Outcome Measures
Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00893802
Brief Title
Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes
Official Title
Influence of Periodontal Treatment in Pregnant Women Attending Antenatal Care at a Public Health Center in Adverse Pregnant Outcomes: a Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes.
Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. Treatment will be performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will receive PROPH and OHI during pregnancy and will be referred for treatment after delivery. Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (< 37 weeks), low birth weight (< 2.500 Kg), late abortion (14-24 weeks) or abortion (< 14 weeks). The results obtained will be statistically evaluated according to OR, unpaired t test and paired t test.
It is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.
Detailed Description
All patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. Those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (NIG), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (IG).
Patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. Treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. Obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease
Keywords
periodontal disease, pregnancy, periodontal treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Periodontal treatment
Arm Type
Experimental
Arm Description
Scaling and root planning
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Scaling and root planning
Intervention Description
Intervention will consist of supra and subgingival scaling and root planning performed by a single trained periodontist using Gracey curettes (Hu-Friedy, Chicago, USA) without local or general anesthesia during the second trimester of gestation, followed by professional prophylaxis and oral hygiene instruction. Treatment will be performed only once during study.
Primary Outcome Measure Information:
Title
Primary outcome measures recorded are: preterm birth (PTB), defined as delivery < 37 weeks; low birth weight (LBW), defined as < 2.500Kg birth weight; preterm birth and low birth weight
Time Frame
Within 30 days after delivery
Secondary Outcome Measure Information:
Title
Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks)
Time Frame
Within 30 days after development
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
confirmed singleton gestations
pregnancy of 9-24
systemically healthy women
age range: 16-39 years old
Exclusion Criteria:
non confirmed pregnancy
age inferior to 16 years or superior to 39 years
multiple gestations
smoking
alcohol or drugs abuse
history of congenital heart disease
current use of corticosteroids or antibiotics
presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana P Sant'Ana, DDS PhD
Organizational Affiliation
Associate Professor - School of Dentistry at Bauru-USP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marinele R Campos, DDS
Organizational Affiliation
Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jardim Redentor I Public Health Center
City
Bauru
State/Province
SP
ZIP/Postal Code
17100-000
Country
Brazil
12. IPD Sharing Statement
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Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes
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