NCT00893802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2002

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2009

Completed
Last Updated

May 6, 2009

Status Verified

May 1, 2009

Enrollment Period

1 year

First QC Date

May 4, 2009

Last Update Submit

May 4, 2009

Conditions

Periodontal Disease

Keywords

periodontal diseasepregnancyperiodontal treatment

Outcome Measures

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

    Within 30 days after delivery

Secondary Outcomes (1)

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

    Within 30 days after development

Study Arms (2)

Periodontal treatment

EXPERIMENTAL

Scaling and root planning

Other: Scaling and root planning

Control

NO INTERVENTION

Interventions

Scaling and root planningOTHER

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.

Periodontal treatment

Eligibility Criteria

Age16 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • confirmed singleton gestations
  • pregnancy of 9-24
  • systemically healthy women
  • age range: 16-39 years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jardim Redentor I Public Health Center

Bauru, São Paulo, 17100-000, Brazil

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Adriana P Sant'Ana, DDS PhD

    Associate Professor - School of Dentistry at Bauru-USP

    STUDY DIRECTOR

  • Marinele R Campos, DDS

    Graduation student on Periodontics (Master level). School of Dentistry at Bauru - USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2009

First Posted

May 6, 2009

Study Start

August 1, 2001

Primary Completion

August 1, 2002

Study Completion

September 1, 2002

Last Updated

May 6, 2009

Record last verified: 2009-05

Locations

BR(1)