Effect of Non-surgical Periodontal Treatment (EONSPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Danielli Maria Zucateli Feitosa, Universidade Federal do Maranhão
ClinicalTrials.gov Identifier:
NCT01533792
First received: January 28, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Periodontal Diseases
Adverse Effects
Procedure: Supra/subgingival scaling using periodontal curette scraping
Procedure: Supra and subgingival scaling
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial

Further study details as provided by Universidade Federal do Maranhão:

Primary Outcome Measures:
  • Effect of non-surgical periodontal treatment in pregnancy with periodontal disease [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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).


  • Effect of non-surgical periodontal treatment in pregnancy with periodontitis [ Time Frame: Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy). ] [ Designated as safety issue: No ]

    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.



Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   15 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Danielli Maria Zucateli Feitosa, MsC, Universidade Federal do Maranhão
ClinicalTrials.gov Identifier: NCT01533792     History of Changes
Other Study ID Numbers: UFMA-2011-DANI
Study First Received: January 28, 2012
Last Updated: February 15, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal do Maranhão:
Treatment
pregnant women
periodontitis
dental scaling
dental plaque

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 23, 2014