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

Chronic Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126267
• Other study ID #: 07172212.3.0000.5149
• Status: Completed
• Phase: N/A
• First received: April 21, 2014
• Last updated: April 27, 2014
• Start date: January 2013
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Centro Universitario de Lavras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Disease
• Periodontal Diseases
• Periodontitis

Intervention

Procedure:
• Scaling and root planing
Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
• 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)
• Chlorhexidine gluconate solution
Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
• Azithromycin
Azithromycin (500 mg) once daily for 3 consecutive days.

Locations

Country	Name	City	State
Brazil	Douglas Campideli Fonseca	Lavras	Minas Gerais

Sponsors (2)

Lead Sponsor	Collaborator
Centro Universitario de Lavras	Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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 aggressiv — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 180 days after treatment	No
Secondary	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	Baseline and 180 days after treatment	No