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

NCT03629288 | Completed DMC

• 1 other identifier: 038
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 non-surgical periodontal therapy (NSPT) plus azithromycin, and the control group received NSPT plus placebo. Probing Pocket Depth (PPD) Clinical Attachment Level (CAL),O'Leary index (OI) 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).

Conditions

Periodontitis

Keywords

Azithromycin; Periodontal debridement; Antibiotics; Periodontitis

Outcome Measures

Primary Outcomes (1)

• Difference between groups (placebo v/s azithromycin) in the mean (±SD) and changes or delta (∆) in number of sites with PPD 1-3 mm, 4-6 mm and ≥ 7 mm in stage III grade B periodontitis patients, before and 1, 3 and 6 months after NSPT.

  Before, 1, 3 and 6 month after performing NSPT with placebo or azithromycin, PPD was measured in all the patients in the study and corresponds to the distance in millimeters from the gingival margin (MG) to the inserted probe´s tip of the most apical portion of the periodontal pocket. It was obtained by measuring with a North Carolina periodontal probe (Hu-Friedy® Manufacturing Inc., Chicago, IL, USA), from the bottom of the pocket to the MG, in a position parallel to the vertical axis of the tooth, with a pressure no greater than 0.25 Newton (N). PD was performed in a circular direction over the entire surface of each tooth, registering the 6 deepest sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual). Subsequently, those sites with PPD 1-3 mm, 4-6 mm and ≥ 7 mm were counted and the significance of differences between groups at each time point was assessed using the unpaired t-test (p\>0.05) or Mann-Whitney U test.

  Baseline,1, 3 and 6 month

Secondary Outcomes (5)

• Risk for disease progression, according to Lang & Tonetti (2003).

  Baseline and 6 month

• Clinical Attachment Level (CAL) gain in the sixth month after NSPT with placebo or azithromycin.

  Baseline and 6 month

• Difference between groups for the O'Leary index (OI),in stage III grade B periodontitis patients before and 1, 3 and 6 month after performing NSPT with placebo or azithromycin.

  Baseline,1, 3 and 6 month

• Difference between groups for the bleeding on probing (BoP) Index, in stage III grade B periodontitis patients before and 1, 3 and 6 month after performing NSPT with placebo or azithromycin.

  Baseline,1, 3 and 6 month

• Presence of periodontopathogens before, 3 and 6 month after performing NSPT with placebo or azithromycin.

  Baseline, 3 and 6 month

Study Arms (2)

Periodontal treatment, lactose tab

PLACEBO COMPARATOR

Periodontal treatment (scaling and root planning) and one tablet containing lactose once a day for three days immediately after the scaling and root planning.

Other: Lactose tab

Periodontal treatment, Antibiotic

EXPERIMENTAL

Periodontal treatment (scaling and root planning) and one tablet containing 500 milligrams (mg) of Azithromycin once a day for three days immediately after the scaling and root planning.

Drug: Azithromycin

Interventions

Lactose tab OTHER

Tablet containing lactose Procedure: Periodontal treatment Scaling and root planning

Periodontal treatment, lactose tab

Azithromycin DRUG

Tablet containing 500mg Azithromicyn. Procedure: Periodontal treatment Scaling and root planning

Also known as: Azithromycin 500mg Tab

Periodontal treatment, Antibiotic

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (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) Periodontitis untreated, stage III generalized, grade B, according to the AAP/EFP classification of 2018 29. For Stage III, the following criteria are considered: Severity: Interdental CAL at the site of greatest loss ≥ 5 mm, radiographic bone loss extending to the middle or apical third of the root, and tooth loss due to periodontitis ≤ 4 teeth). Complexity: PPD ≥ 6mm, vertical bone loss ≥ 3mm, furcation involvement Class II or III and Moderate ridge defect. Generalized: \>30% of teeth involved. Grade B: Indirect evidence of progression ( % bone loss/age: 0.25 to 1.0)

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Study Sites (1)

Universidad Nacional Andres Bello

Viña del Mar, Región de Valparaíso, 2520000, Chile

Location

Related Publications (6)

• Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.

  PMID: 29926952 BACKGROUND

• Meissner K, Bingel U, Colloca L, Wager TD, Watson A, Flaten MA. The placebo effect: advances from different methodological approaches. J Neurosci. 2011 Nov 9;31(45):16117-24. doi: 10.1523/JNEUROSCI.4099-11.2011.

  PMID: 22072664 BACKGROUND

• Suchy FJ, Brannon PM, Carpenter TO, Fernandez JR, Gilsanz V, Gould JB, Hall K, Hui SL, Lupton J, Mennella J, Miller NJ, Osganian SK, Sellmeyer DE, Wolf MA. National Institutes of Health Consensus Development Conference: lactose intolerance and health. Ann Intern Med. 2010 Jun 15;152(12):792-6. doi: 10.7326/0003-4819-152-12-201006150-00248. Epub 2010 Apr 19. No abstract available.

  PMID: 20404261 BACKGROUND

• Jellema P, Schellevis FG, van der Windt DA, Kneepkens CM, van der Horst HE. Lactose malabsorption and intolerance: a systematic review on the diagnostic value of gastrointestinal symptoms and self-reported milk intolerance. QJM. 2010 Aug;103(8):555-72. doi: 10.1093/qjmed/hcq082. Epub 2010 Jun 3.

  PMID: 20522486 BACKGROUND

• Sampaio E, Rocha M, Figueiredo LC, Faveri M, Duarte PM, Gomes Lira EA, Feres M. Clinical and microbiological effects of azithromycin in the treatment of generalized chronic periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2011 Sep;38(9):838-46. doi: 10.1111/j.1600-051X.2011.01766.x. Epub 2011 Jul 19.

  PMID: 21770996 RESULT

• Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.

  PMID: 15643744 RESULT

MeSH Terms

Conditions

Periodontitis

Interventions

Lactose; Azithromycin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Mariely A Navarrete, MSc

  Universidad Nacional Andres Bello

  STUDY DIRECTOR

• Mariely A Navarrete, MSc

  Universidad Nacional Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Director of Graduate Periodontics Faculty of Dentistry Andres Bello University, Viña del Mar campus

Model Details: A double-blind, randomized controlled trial, where patients with a Severe Periodontitis with potencial for additional tooth loss and moderate rate of progression (Stage III grade B). The intervention group received non-surgical periodontal therapy (NSPT) plus azithromycin, and the control group received NSPT plus placebo. The clinical variables were measured before the treatment, and in the first, third and sixth month of the end of the NSPT, while the microbiological variables were measured before the treatment and in the third and sixth month after treatment.

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: August 14, 2018
• Study Start: March 1, 2016
• Primary Completion: September 2, 2016
• Study Completion: October 30, 2016
• Last Updated: September 9, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)