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Completed

NCT Number: NCT02126267

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Douglas Campideli Fonseca

Lavras, Minas Gerais, 37200000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

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

Full mouth disinfection

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

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

Drug

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

Azithromycin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centro Universitario de Lavras

Other

Collaborators

  • Federal University of Minas Gerais

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2014
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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