ActivePhase 2ACTRN12615001047583

Adjunctive Systemic Azithromycin versus Amoxycillin and Metronidazole in Non-Surgical Mechanical Therapy of Periodontitis

Efficacy of adjunctive azithromycin versus amoxycillin and medtronidazole, and placebo in the treatment of chronic periodontitis in adults

Sponsor

Meredith Owen

Enrollment

83 participants

Start Date

Sep 6, 2016

Study Type

Interventional

Conditions

Chronic Periodontitis

Summary

The aim of this study is to compare the clinical and microbial changes occurring in chronic periodontitis patients receiving non-surgical treatment alone or with systemically administered azithromycin or with amoxicyllin and metronidazole. The hypothesis is that non-surgical periodontal treatment in combination with systemically administered azithromycin will have superior effects on treatment outcomes (clinical and microbial parameters) than non-surgical periodontal therapy alone or in combination with systemically adminstered amoxicillin and metronidazole.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

Patients with moderate - severe chronic periodontitis
Approximal Plaque Index <40%
Sulcus Bleeding Index <30%

Exclusion Criteria6

Patients with known allergies to test antimicrobial agents
Patients who have received periodontal therapy in the previous 3 months
Patients who have used systemic antibiotics within the previous 3 months
Patients who are pregnant or breastfeeding
Patients with systemic conditions that could influence the outcome of periodontal therapy
Patients that require antibiotic prophylaxis

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Interventions

Interventions: Scaling & root planing with Azithromycin - 500mg, once a day, 4 days Scaling & root planing with Amoxycillin (500mg) & Metronidazole (400mg) both 3 times a day for 8 days Scaling & r

Interventions: Scaling & root planing with Azithromycin - 500mg, once a day, 4 days Scaling & root planing with Amoxycillin (500mg) & Metronidazole (400mg) both 3 times a day for 8 days Scaling & root planing with Placebo A patient questionnaire will be given to check for compliance and record any adverse effects Scaling and root planing - removal of hard and soft deposits on the tooth and root surfaces that contribute to infection under local anaesthesia - divided into 2 sessions (right hand side followed by left hand side of mouth) from 24 hours - 1 week apart Drug administration - oral tablet - begins the morning of the first session of scaling and root planing