Effect of Non-surgical Periodontal Treatment (EONSPT)

Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial

Objective: The objective of this research was to compare the effect of a single session supragingival scaling in a group of pregnant women with periodontal disease with a group that received supra and subgingival scaling.

Methods: The investigators included 34 pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place. Women were divided into two groups, the group 1 received supra and subgingival scaling associated with oral hygiene orientation (OHO) and the group 2 received only supragingival scaling with OHO too.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Adverse Effects
• Intervention / Treatment: Procedure: Supra/subgingival scaling using periodontal curette scraping; Procedure: Supra and subgingival scaling

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 43 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women between 15 and 43 who had at least 4 teeth with probing depth ≥ 4 mm or clinical attachment loss ≥ 3 mm, with bleeding on probing in the same place.

Exclusion Criteria:

• Patients with systemic disease or who used medications that interfere in the etiological factors of periodontal disease in the last six months, who wore braces and / or prosthetic devices, and women smokers who did not complete treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Supra/subgingival therapy; The experimental group received supra and subgingival scaling associated with oral hygiene orientation (OHO)	Procedure: Supra/subgingival scaling using periodontal curette scraping; The experimental group received supra and subgingival therapy with periodontal curettes; Procedure: Supra and subgingival scaling; The experimental group received supra and subgingival scaling.
ACTIVE_COMPARATOR: Control group; Control group received only supragingival scaling with OHO too.	Procedure: Supra/subgingival scaling using periodontal curette scraping; The experimental group received supra and subgingival therapy with periodontal curettes; Procedure: Supra and subgingival scaling; The experimental group received supra and subgingival scaling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of non-surgical periodontal treatment in pregnancy with periodontal disease	A single calibrated examiner performed clinical examination in pregnant women participating in the measurement of parameters: probing depth, clinical attachment level, hyperplasia, recession, bleeding, presence of plaque and tooth mobility on a standardized form. Quantitative parameters were evaluated at six sites per tooth: mesio/medium/ distobuccal and mesio/medium/distolingual through millimeter periodontal probe-type Williams. The bleeding and the presence of plaque in dichotomous variables were measured: present and absent. All patients received oral hygiene orientation (OHO).	30 days
Effect of non-surgical periodontal treatment in pregnancy with periodontitis	The patients were randomly divided by lottery into two groups. The group 1, termed SUPRA/SUB received OHO, supra and subgingival scraping and the group 2: SUPRA supragingival scraping and OHO. In both groups, the scaling procedure was performed using periodontal curettes type Mc Call 13-14 and 17-18 (DUFLEX) in one session. Within 30 days after the initial session scraping clinical parameters were reevaluated, and now, according to every need, the patients were submitted to the supra and subgingival therapy. Noting that full dental care was provided to participants.	Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy).

Collaborators and Investigators

• Sponsor: Universidade Federal do Maranhão

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: January 28, 2012
• First Submitted That Met QC Criteria: February 12, 2012
• First Posted (ESTIMATE): February 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 17, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Treatment; pregnant women; periodontitis; dental plaque; dental scaling
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: UFMA-2011-DANI