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

NCT ID: NCT02126267

Last Updated: 2014-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-03-31

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.

Conditions

Periodontal Disease; Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Full mouth disinfection

Intervention Type: PROCEDURE

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

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.

Group Type: EXPERIMENTAL

Full mouth disinfection

Intervention Type: PROCEDURE

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

Chlorhexidine gel and gluconate

Intervention Type: DRUG

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)

Chlorhexidine gluconate solution

Intervention Type: DRUG

Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.

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.

Group Type: EXPERIMENTAL

Full mouth disinfection

Intervention Type: PROCEDURE

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

Azithromycin

Intervention Type: DRUG

Azithromycin (500 mg) once daily for 3 consecutive days.

Scaling and root planing (SRP)

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

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: PROCEDURE

Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

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;

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: PROCEDURE

Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

Azithromycin

Intervention Type: DRUG

Azithromycin (500 mg) once daily for 3 consecutive days.

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

Group Type: EXPERIMENTAL

Scaling and root planing

Intervention Type: PROCEDURE

Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

Chlorhexidine gluconate solution

Intervention Type: DRUG

Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.

Interventions

Scaling and root planing

Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;

Intervention Type: 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

Intervention Type: PROCEDURE

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)

Intervention Type: DRUG

Chlorhexidine gluconate solution

Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.

Intervention Type: DRUG

Azithromycin

Azithromycin (500 mg) once daily for 3 consecutive days.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: collaborator

Centro Universitario de Lavras

OTHER

Sponsor Role: lead

Responsible Party

Douglas Campideli Fonseca

Master of Science

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas C Fonseca, Ms

Role: PRINCIPAL_INVESTIGATOR

Universitary Center of Lavras

Locations

Douglas Campideli Fonseca

Lavras, Minas Gerais, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 22571226 (View on PubMed)

Other Identifiers

07172212.3.0000.5149

Identifier Type: -

Identifier Source: org_study_id