Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis

NCT02839408 | Unknown Phase 2 DMC

• 1 other identifier: FONDECYT 1130570.b
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized placebo- controlled clinical trial is to evaluate the effects of Lactobacillus rhamnosus SP1- containing probiotic tablets and azithromycin tablets as an adjunct to scaling and root planning (SRP). Material and methods: Fifty-four chronic periodontitis patients will be recruited and monitored clinically, immunologically and microbiologically at baseline, 3, 6, 9 and 12 months after therapy. All patients will receive scaling and root planning and randomly will be assigned over an probiotic experimental (SRP + probiotic, n=18), antibiotic experimental (SRP + Azithromycin, n=18) or control (SRP + placebo, n=18) group. Probiotic will be used once per day during 3 months. Antibiotic will be used once per day during 5 days.

Conditions

Chronic Periodontitis

Keywords

periodontitis; azithromycin; probiotic

Outcome Measures

Primary Outcomes (1)

• Differences of at least 1mm between groups for clinical attachment level changes

  baseline, 3, 6, 9 and 12 month

Secondary Outcomes (5)

• Differences between groups for probing depth changes

  baseline, 3, 6, 9 and 12 month

• Differences between groups for bleeding on probing changes

  baseline, 3, 6, 9 and 12 month

• Differences between groups for plaque index changes

  baseline, 3, 6, 9 and 12 month

• Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid

  baseline, 3, 6, 9 and 12 month

• Differences between groups for levels of periodontal pathogens changes

  baseline, 3, 6, 9 and 12 month

Study Arms (3)

Periodontal treatment, talc powder tab

PLACEBO COMPARATOR

Periodontal treatment (scaling and root planning) and one tablet containing talc powder per day during 3 months

Other: Talc powder; Procedure: Periodontal treatment Scaling and root planning

Periodontal treatment, Probitic

EXPERIMENTAL

Periodontal treatment (scaling and root planning) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months.

Dietary Supplement: Lactobacillus rhamnosus SP1; Procedure: Periodontal treatment Scaling and root planning

Periodontal treatment, Antibiotic

EXPERIMENTAL

Periodontal treatment (scaling and root planning) and one tablet containing 500mg Azithromycin

Drug: Azithromycin; Procedure: Periodontal treatment Scaling and root planning

Interventions

Lactobacillus rhamnosus SP1 DIETARY_SUPPLEMENT

Sachet containing Lactobacillus rhamnosus SP1

Periodontal treatment, Probitic

Azithromycin DRUG

Tablet containing 500mg Azithromicyn

Periodontal treatment, Antibiotic

Talc powder OTHER

Sachet containing talc powder and tablet containing talc powder

Periodontal treatment, talc powder tab

Periodontal treatment Scaling and root planning PROCEDURE

Periodontal treatment, Antibiotic; Periodontal treatment, Probitic; Periodontal treatment, talc powder tab

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• natural teeth, excluding third molars
• posterior teeth
• years old
• teeth with periodontal sites with probing depths ≥5mm, clinical attachment loss ≥3mm Bleeding on probing ≥20% of sites Extensive bone loss determined radiographically

You may not qualify if:

• Periodontal treatment before the time of examination
• Systemic illness
• Pregnancy Anticoagulant, antibiotics and non- steroid anti- inflammatory therapy in the 6-month period before the study

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Morales A, Contador R, Bravo J, Carvajal P, Silva N, Strauss FJ, Gamonal J. Clinical effects of probiotic or azithromycin as an adjunct to scaling and root planning in the treatment of stage III periodontitis: a pilot randomized controlled clinical trial. BMC Oral Health. 2021 Jan 7;21(1):12. doi: 10.1186/s12903-020-01276-3.

  PMID: 33413320 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Azithromycin; Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

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; Sulfoxides; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 21, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 27, 2016

Record last verified: 2016-07

Locations

CL (1)