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Completed

NCT Number: NCT01533792

Effect of Non-surgical Periodontal Treatment

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.

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Key information

Age range

15 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Supra/subgingival scaling using periodontal curette scraping

Procedure

The experimental group received supra and subgingival therapy with periodontal curettes

Supra and subgingival scaling

Procedure

The experimental group received supra and subgingival scaling.

Primary outcomes

  1. Effect of non-surgical periodontal treatment in pregnancy with periodontal disease

    Time frame: 30 days

    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).

  2. 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).

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Maranhão

Other

Registry information

Official study title

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

Acronym: EONSPT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2012
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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