Effect of Non-surgical Periodontal Treatment

NCT01533792 | Completed Phase 2

• 1 other identifier: UFMA-2011-DANI
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases; Adverse Effects

Keywords

Treatment; pregnant women; periodontitis; dental scaling; dental plaque

Outcome Measures

Primary Outcomes (2)

• 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

• 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).

Study Arms (2)

Supra/subgingival therapy

EXPERIMENTAL

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

Procedure: Supra/subgingival scaling using periodontal curette scraping; Procedure: Supra and subgingival scaling

Control group

ACTIVE COMPARATOR

Control group received only supragingival scaling with OHO too.

Procedure: Supra/subgingival scaling using periodontal curette scraping; Procedure: Supra and subgingival scaling

Interventions

Supra/subgingival scaling using periodontal curette scraping PROCEDURE

The experimental group received supra and subgingival therapy with periodontal curettes

Control group; Supra/subgingival therapy

Supra and subgingival scaling PROCEDURE

The experimental group received supra and subgingival scaling.

Control group; Supra/subgingival therapy

Eligibility Criteria

• Age: 15 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Maranhão: lead

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Dental Plaque

Interventions

Dental Scaling

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Prophylaxis; Periodontics; Dentistry; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MsC

Study Record Dates

• First Submitted: January 28, 2012
• First Posted: February 15, 2012
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 17, 2012

Record last verified: 2012-02