Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00893802
Recruitment Status : Completed
First Posted : May 6, 2009
Last Update Posted : May 6, 2009
Information provided by:
University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Periodontal Disease Other: Scaling and root planning Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : August 2001
Actual Primary Completion Date : August 2002
Actual Study Completion Date : September 2002

Arm Intervention/treatment
Experimental: Periodontal treatment
Scaling and root planning
Other: Scaling and root planning
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.

No Intervention: Control

Primary Outcome Measures :
  1. 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 Measures :
  1. Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks) [ Time Frame: Within 30 days after development ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00893802

Jardim Redentor I Public Health Center
Bauru, SP, Brazil, 17100-000
Sponsors and Collaborators
University of Sao Paulo
Study Director: Adriana P Sant'Ana, DDS PhD Associate Professor - School of Dentistry at Bauru-USP
Principal Investigator: Marinele R Campos, DDS Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP

Responsible Party: Adriana Campos Passanezi Sant'Ana, Discipline of Periodontics, School of Dentistry at Bauru-USP Identifier: NCT00893802     History of Changes
Other Study ID Numbers: CEP102/2002/FOB
CEP 102/2002
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: May 6, 2009
Last Verified: May 2009

Keywords provided by University of Sao Paulo:
periodontal disease
periodontal treatment

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases