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Effect of Non-surgical Periodontal Treatment (EONSPT)

Primary Purpose

Periodontal Diseases, Adverse Effects

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Supra/subgingival scaling using periodontal curette scraping
Supra and subgingival scaling
Sponsored by
Universidade Federal do Maranhão
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Treatment, pregnant women, periodontitis, dental scaling, dental plaque

Eligibility Criteria

15 Years - 43 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Supra/subgingival therapy

    Control group

    Arm Description

    The experimental group received supra and subgingival scaling associated with oral hygiene orientation (OHO)

    Control group received only supragingival scaling with OHO too.

    Outcomes

    Primary Outcome Measures

    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).
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 28, 2012
    Last Updated
    February 15, 2012
    Sponsor
    Universidade Federal do Maranhão
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01533792
    Brief Title
    Effect of Non-surgical Periodontal Treatment
    Acronym
    EONSPT
    Official Title
    Effect of Non-surgical Periodontal Treatment on Pregnant Women With Periodontitis: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2010 (undefined)
    Primary Completion Date
    December 2010 (Actual)
    Study Completion Date
    December 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Maranhão

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Adverse Effects
    Keywords
    Treatment, pregnant women, periodontitis, dental scaling, dental plaque

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supra/subgingival therapy
    Arm Type
    Experimental
    Arm Description
    The experimental group received supra and subgingival scaling associated with oral hygiene orientation (OHO)
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    Control group received only supragingival scaling with OHO too.
    Intervention Type
    Procedure
    Intervention Name(s)
    Supra/subgingival scaling using periodontal curette scraping
    Intervention Description
    The experimental group received supra and subgingival therapy with periodontal curettes
    Intervention Type
    Procedure
    Intervention Name(s)
    Supra and subgingival scaling
    Intervention Description
    The experimental group received supra and subgingival scaling.
    Primary Outcome Measure Information:
    Title
    Effect of non-surgical periodontal treatment in pregnancy with periodontal disease
    Description
    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).
    Time Frame
    30 days
    Title
    Effect of non-surgical periodontal treatment in pregnancy with periodontitis
    Description
    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.
    Time Frame
    Assess periodontal disease at times: initial (when pregnancy arrived) and final (30 days after periodontal therapy).

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    43 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

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    Effect of Non-surgical Periodontal Treatment

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