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Completed

NCT Number: NCT00893802

Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes

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.

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Key information

Conditions

Periodontal Disease Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

16 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jardim Redentor I Public Health Center

Bauru, São Paulo, 17100-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Scaling and root planning

Other

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 outcomes

  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 outcomes

  1. Secondary outcome measures are: late abortion (14-24 gestational weeks); and abortion (< 14 gestational weeks)

    Time frame: Within 30 days after development

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Influence of Periodontal Treatment in Pregnant Women Attending Antenatal Care at a Public Health Center in Adverse Pregnant Outcomes: a Controlled Clinical Trial

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 6, 2009
Registry last updated
May 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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