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
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
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
NCT ID
NCT01533792
First Posted
January 28, 2012
Last Updated
February 15, 2012
Sponsor
Universidade Federal do Maranhão
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
Learn more about this trial
Effect of Non-surgical Periodontal Treatment
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