Effect of Non-surgical Periodontal Treatment

Periodontal Diseases Clinical Trial

— EONSPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01533792
• Other study ID #: UFMA-2011-DANI
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2012
• Last updated: February 15, 2012
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: February 2012
• Source: Universidade Federal do Maranhão
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 43 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effects
• Gingival Diseases
• Periodontal Diseases

Intervention

Procedure:
• Supra/subgingival scaling using periodontal curette scraping
The experimental group received supra and subgingival therapy with periodontal curettes
• Supra and subgingival scaling
The experimental group received supra and subgingival scaling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Maranhão

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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).	No