Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection

April 27, 2014 updated by: Douglas Campideli Fonseca, Centro Universitario de Lavras

Clinical and Microbiological Evaluation of Techniques for Scaling and Root Planing Per Quadrant and One Stage Full Mouth Disinfection Associated With Azithromycin or Chlorhexidine: Randomized Controlled Trial

Evaluate and compare the effectiveness in a clinical and microbial perspective one stage full-mouth disinfection technique in relation to scaling and root planing per quadrant associated with chlorhexidine or azithromycin.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Seventy -seven systemically healthy subjects with chronic periodontitis were randomly included in 6 different predefined groups. The following periodontal parameters were evaluated: probing depth , clinical attachment level , plaque index, gingival index and percentage of areas affected by periodontal disease. Microbiologically were evaluated the bacterial load and specific load of five bacterias: The quantification of the bacteria was performed by real-time Polymerase Chain Reaction . The clinical and microbial baseline evaluations were performed ( periodontal pre- therapy) , 90 and 180 days after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Minas Gerais
      • Lavras, Minas Gerais, Brazil, 37200000
        • Douglas Campideli Fonseca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of slight-moderate chronic periodontitis

Exclusion Criteria:

  • Those who were making regular use of antibiotics or anti-inflammatory drugs or had done up to three months before the beginning of the study;
  • those who were making regular use (twice a day) of oral rinses with chlorhexidine or essential oils or have made regular use within three months prior to study entry;
  • individuals with a history of sensitivity to chlorhexidine or azithromycin;
  • subjects undergoing periodontal therapy include dental scaling procedures in the 12 months preceding the start of the study;
  • subjects with impaired bifurcation or trifurcation class III;
  • who required antibiotic prophylaxis for conducting clinical periodontal examination
  • subjects with removable partial dentures and removable or fixed orthodontic appliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Full mouth disinfection - FMD
n = 10: Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Procedure: Full mouth disinfection
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Experimental: FMD + chlorhexidine (FMD-CX)
n = 15: Same as FMD with the inclusion of chlorhexidine in office (application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)). In addition, use was made of homemade CX 0.2% for 60 days after the scaling in a single phase.
Procedure: Full mouth disinfection
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Drug: Chlorhexidine gel and gluconate
application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)
Drug: Chlorhexidine gluconate solution
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
Experimental: FMD + azithromycin (FMD-AZ)
n = 15: Same as with the FMD include the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the scaling.
Procedure: Full mouth disinfection
Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
Drug: Azithromycin
Azithromycin (500 mg) once daily for 3 consecutive days.
Experimental: Scaling and root planing (SRP)
(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Procedure: Scaling and root planing
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Experimental: SRP + azithromycin (SRP-AZ)
n = 11: Same as scaling and root planing group (SRP) with inclusion of the use of azithromycin (500 mg) once daily for 3 consecutive days. Medication was started the same day as the end of the last scaling hemi-arch;
Drug: Azithromycin
Azithromycin (500 mg) once daily for 3 consecutive days.
Procedure: Scaling and root planing
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Experimental: SRP + chlorhexidine (SRP-CX)
n = 13 : Same as group scaling and root planing (SRP) with the inclusion of home use of CX 0.2% for 60 consecutive days after the end of the first session of scaling
Drug: Chlorhexidine gluconate solution
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
Procedure: Scaling and root planing
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in clinical attachment
Time Frame: Baseline and 180 days after treatment
In this parameter we will evaluate the distance from the cement-enamel junction to the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
Baseline and 180 days after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in probing depth
Time Frame: Baseline and 180 days after treatment
In this parameter we will evaluate the distance between the gingival margin and the bottom of the periodontal pocket or gingival sulcus. This measurement is made with a periodontal probe graduated in millimeters
Baseline and 180 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Universitario de Lavras

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Minas Gerais

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Douglas C Fonseca, Ms, Universitary Center of Lavras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07172212.3.0000.5149

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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