Efficacy of Azithromycin as an Adjunct to Non-Surgical Periodontal Treatment

• Status: Completed
• Trial end date: 2016-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effect of the systemic administration of azithromycin as a therapy associated with non-surgical periodontal treatment, in the clinical and microbiological variables of patients with Severe Periodontitis with moderate rate of progression (Stage III grade B). A double-blind, randomized, controlled trial was conducted with 18 voluntary patients with a history of moderate to severe chronic periodontitis, who met the inclusion and exclusion criteria and signed an informed consent.

The intervention group received Scaling and Root Planning (SRP) plus azithromycin, and the control group received SRP plus placebo. Probing Pocket Depth (PPD) Clinical Attachment Level (CAL), Plaque Index (PI) and Bleeding on Probing (BoP) were evaluated as clinical variables while Porphyromonas gingivalis (Pg), Tannerella forsythia (Tf), Treponema denticola (Td), Fusobacterium nucleatum (Fn) were the microbiological variables detected by conventional Polymerase chain reaction (PCR).

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad Nacional Andres Bello
• Treatments: Azithromycin

Criteria

Inclusion criteria:

(I) Patients ≥ 18 years; (II) classified by the American Society of Anesthesiologists (ASA) as ASA I or ASA II that are compatible with local anaesthesia procedures; (III) At least 10 natural teeth present, excluding semi-erupted third molars; (IV) Presence of at least 6 sites with a probing depth (PD) ≥ 5mm and clinical attachment loss (CAL) ≥ 4mm.

Exclusion criteria: Patients with (I) Haemostasis disorders; (II) Medication associated with gingival disorders such as: Anticonvulsants (Phenytoin), Calcium channel blockers (Nifedipine), Immunosuppressive drugs (Cyclosporins); (III) Systemic diseases that affect the immunoinflammatory response; (IV) Treatment with antacids on a regular basis due to chronic gastritis and/or self-medication with antacids; (V) Treatment with drugs such as: warfarin, digoxin and acetylsalicylic acid; (VI) History of allergy to local anesthetics; (VII) Orthodontic appliances; (VIII) Antibiotic treatment in the previous 3 months; (IX) History periodontal treatment; (X) Pregnancy; (XI) Valvular prostheses or failures in heart valves, with risk of endocarditis; (XII) Psychic and Intellectual Disability, in accordance with Chilean law number 20,584, title II, paragraph 8, article 28; (XIII) Consumption of more than 10 cigarettes per day; (XIV) Allergy to AZM; (XV) Lactose intolerance.