search
Back to results

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

Primary Purpose

Periodontal Disease, Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Scaling and root planing
Full mouth disinfection
Chlorhexidine gel and gluconate
Chlorhexidine gluconate solution
Azithromycin
Sponsored by
Centro Universitario de Lavras
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Disease focused on measuring periodontal disease, therapy, anti-bacterial agents, Randomized Controlled Trials

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Douglas Campideli Fonseca

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Full mouth disinfection - FMD

FMD + chlorhexidine (FMD-CX)

FMD + azithromycin (FMD-AZ)

Scaling and root planing (SRP)

SRP + azithromycin (SRP-AZ)

SRP + chlorhexidine (SRP-CX)

Arm Description

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

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.

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.

(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

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;

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

Outcomes

Primary Outcome Measures

Change in clinical attachment
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

Secondary Outcome Measures

Change in probing depth
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

Full Information

First Posted
April 21, 2014
Last Updated
April 27, 2014
Sponsor
Centro Universitario de Lavras
Collaborators
Federal University of Minas Gerais
search

1. Study Identification

Unique Protocol Identification Number
NCT02126267
Brief Title
Evaluation of Techniques for Scaling and Root Planing and One Stage Full Mouth Disinfection
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Lavras
Collaborators
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Disease, Chronic Periodontitis
Keywords
periodontal disease, therapy, anti-bacterial agents, Randomized Controlled Trials

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full mouth disinfection - FMD
Arm Type
Experimental
Arm Description
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
Arm Title
FMD + chlorhexidine (FMD-CX)
Arm Type
Experimental
Arm Description
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.
Arm Title
FMD + azithromycin (FMD-AZ)
Arm Type
Experimental
Arm Description
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.
Arm Title
Scaling and root planing (SRP)
Arm Type
Experimental
Arm Description
(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Arm Title
SRP + azithromycin (SRP-AZ)
Arm Type
Experimental
Arm Description
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;
Arm Title
SRP + chlorhexidine (SRP-CX)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
Intervention Type
Procedure
Intervention Name(s)
Full mouth disinfection
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gel and gluconate
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine gluconate solution
Intervention Description
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
Azithromycin (500 mg) once daily for 3 consecutive days.
Primary Outcome Measure Information:
Title
Change in clinical attachment
Description
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
Time Frame
Baseline and 180 days after treatment
Secondary Outcome Measure Information:
Title
Change in probing depth
Description
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
Time Frame
Baseline and 180 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas C Fonseca, Ms
Organizational Affiliation
Universitary Center of Lavras
Official's Role
Principal Investigator
Facility Information:
Facility Name
Douglas Campideli Fonseca
City
Lavras
State/Province
Minas Gerais
ZIP/Postal Code
37200000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
22571226
Citation
Emingil G, Han B, Ozdemir G, Tervahartiala T, Vural C, Atilla G, Baylas H, Sorsa T. Effect of azithromycin, as an adjunct to nonsurgical periodontal treatment, on microbiological parameters and gingival crevicular fluid biomarkers in generalized aggressive periodontitis. J Periodontal Res. 2012 Dec;47(6):729-39. doi: 10.1111/j.1600-0765.2012.01488.x. Epub 2012 May 9.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs