Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes

NCT ID: NCT00893802

Last Updated: 2009-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2002-09-30

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.

Conditions

Periodontal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Periodontal treatment

Scaling and root planning

Group Type: EXPERIMENTAL

Scaling and root planning

Intervention Type: 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.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Discipline of Periodontics, School of Dentistry at Bauru-USP

Principal Investigators

Adriana P Sant'Ana, DDS PhD

Role: STUDY_DIRECTOR

Associate Professor - School of Dentistry at Bauru-USP

Marinele R Campos, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Jardim Redentor I Public Health Center

Bauru, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CEP 102/2002

Identifier Type: -

Identifier Source: secondary_id

CEP102/2002/FOB

Identifier Type: -

Identifier Source: org_study_id