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

Chronic Periodontitis Clinical Trial

Official title:

Efficacy of Oral Probiotic and Antibiotic Administration in Clinical, Immunological and Microbiological Parameters of Patients With Chronic Periodontitis Treated With Non Surgical Periodontal Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02839408
• Other study ID #: FONDECYT 1130570.b
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 18, 2016
• Last updated: September 25, 2016
• Start date: June 2015
• Est. completion date: March 2017

Study information

• Verified date: July 2016
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 14 natural teeth, excluding third molars

• 10 posterior teeth

• 35 years old

• 5 teeth with periodontal sites with probing depths =5mm, clinical attachment loss =3mm Bleeding on probing =20% of sites Extensive bone loss determined radiographically

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus SP1
Sachet containing Lactobacillus rhamnosus SP1

Drug:
• Azithromycin
Tablet containing 500mg Azithromicyn

Other:
• Talc powder
Sachet containing talc powder and tablet containing talc powder

Procedure:
• Periodontal treatment Scaling and root planning

Locations

Country	Name	City	State
Chile	Faculty of Dentistry of University of Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of at least 1mm between groups for clinical attachment level changes		baseline, 3, 6, 9 and 12 month	Yes
Secondary	Differences between groups for probing depth changes		baseline, 3, 6, 9 and 12 month	Yes
Secondary	Differences between groups for bleeding on probing changes		baseline, 3, 6, 9 and 12 month	Yes
Secondary	Differences between groups for plaque index changes		baseline, 3, 6, 9 and 12 month	Yes
Secondary	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	Yes
Secondary	Differences between groups for levels of periodontal pathogens changes		baseline, 3, 6, 9 and 12 month	Yes