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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001047583

Enrollment

Registered

2015-10-07

Start date

2016-09-06

Completion date

2017-04-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 & 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 han

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with moderate - severe chronic periodontitis 2. Approximal Plaque Index <40% 3. Sulcus Bleeding Index <30%

Exclusion criteria

1. Patients with known allergies to test antimicrobial agents 2. Patients who have received periodontal therapy in the previous 3 months 3. Patients who have used systemic antibiotics within the previous 3 months 4. Patients who are pregnant or breastfeeding 5. Patients with systemic conditions that could influence the outcome of periodontal therapy 6. Patients that require antibiotic prophylaxis

Outcome results