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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Periodontal Disease, Chronic Periodontitis

Intervention / Treatment
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* Procedure: Scaling and root planing
* Procedure: Full mouth disinfection
* Drug: Chlorhexidine gel and gluconate
* Drug: Chlorhexidine gluconate solution
* Drug: Azithromycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full mouth disinfection - FMD<br>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<br>* 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<br>|
| Experimental: FMD + chlorhexidine (FMD-CX)<br>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<br>* 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<br>Drug: Chlorhexidine gel and gluconate<br>* 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)<br>Drug: Chlorhexidine gluconate solution<br>* Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.<br>|
| Experimental: FMD + azithromycin (FMD-AZ)<br>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<br>* 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<br>Drug: Azithromycin<br>* Azithromycin (500 mg) once daily for 3 consecutive days.<br>|
| Experimental: Scaling and root planing (SRP)<br>(n = 13): scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions; | Procedure: Scaling and root planing<br>* Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;<br>|
| Experimental: SRP + azithromycin (SRP-AZ)<br>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; | Procedure: Scaling and root planing<br>* Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;<br>Drug: Azithromycin<br>* Azithromycin (500 mg) once daily for 3 consecutive days.<br>|
| Experimental: SRP + chlorhexidine (SRP-CX)<br>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 | Procedure: Scaling and root planing<br>* Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;<br>Drug: Chlorhexidine gluconate solution<br>* Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal disease, therapy, anti-bacterial agents, Randomized Controlled Trials