The Effect of Azithromycin in the Treatment of Chronic Periodontitis

NCT01921738 | Completed Phase 2 DMC

• 1 other identifier: mnts-o77
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the effects of Azithromycin (systemic and locally) on the clinical and microbiological parameters of periodontal in patients with chronic periodontitis.

Conditions

Chronic Periodontitis

Keywords

Chronic Periodontitis, Azithromycin, SRP

Outcome Measures

Primary Outcomes (6)

• Change from baseline in Periodontal Pocket Depth

  measurement was done with color coded periodontal probe (Nordent).

  at one, two, three and four months after the intervention.

• Change from baseline in Clinical Attachment Level

  measurement was done with color coded periodontal probe (Nordent).

  at one, two, three and four months after the intervention.

• Change from baseline in Modified Gingival Index

  visual scale, according to Lobene classification.

  at one, two, three and four months after the intervention.

• Change from baseline in Papillary Bleeding Index

  measurement was done with color coded periodontal probe (Nordent), according to (Muhlemann and Saxer) classification.

  at one, two, three and four months after the intervention.

• Change from baseline in Porphyromonas gingivalis count

  measurement was done with Real Time PCR (Primer Design kits).

  at three months after the intervention

• Change from baseline in Actinobacillus actinomycetemcomitans count

  measurement was done with Real Time PCR (Primer Design kits).

  at three months after the intervention

Study Arms (4)

1% Azithromycin gel

EXPERIMENTAL

Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes.

Drug: 1% Azithromycin gel

Azithromycin capsule

EXPERIMENTAL

Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)

Drug: Azithromycin

Placebo Gel

PLACEBO COMPARATOR

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.

Drug: placebo gel

placebo capsule

PLACEBO COMPARATOR

Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days.

Drug: placebo capsule

Interventions

1% Azithromycin gel DRUG

Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes.

Also known as: Avindo Gel (Azithromycin Gel 1%), serial number: 8904069410010

1% Azithromycin gel

Azithromycin DRUG

Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)

Also known as: Zithromax (Zimexir, Exir, Brojerd, Iran), serial number: 6260153032097

Azithromycin capsule

placebo gel DRUG

Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.

Also known as: carbopol 934P/974P

Placebo Gel

placebo capsule DRUG

Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days.

Also known as: sugar capsule

placebo capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate to severe chronic periodontitis
• At least twenty teeth
• Age over 18 years

You may not qualify if:

• With Systemic diseases that affect periodontal conditions such as: diabetes, blood disorders and diseases of immune system
• History of antibiotic therapy within the 4 months prior to study
• History of Allergy to the macrolide group of antibiotics
• Smoking
• The lack of patient cooperation
• History of periodontal treatment during the 4 months prior to the trial
• Pregnancy
• Lactating females
• Patients treated with drugs such as: Anti-acid, Warfarin and Cyclisporine 10) Alcohol use.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

School of Dentistry, Isfahan University of Medical Sciences

Isfahan, Isfahan, 81746-73461, Iran

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Azithromycin; Sugars

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Carbohydrates

Study Officials

• Mahsa Maksabi, D.D.S

  Department of Periodontology, Isfahan School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 13, 2013
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

IR (1)