Clinical trial NCT02839408: Efficacy of Oral Probiotic and Antibiotic Administration in Patients With Chronic Periodontitis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Periodontitis
Keywords: periodontitis
azithromycin
probiotic
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 54
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Differences of at least 1mm between groups for clinical attachment level changes
timeFrame: baseline, 3, 6, 9 and 12 month
Secondary outcomes:
measure: Differences between groups for probing depth changes
timeFrame: baseline, 3, 6, 9 and 12 month
measure: Differences between groups for bleeding on probing changes
timeFrame: baseline, 3, 6, 9 and 12 month
measure: Differences between groups for plaque index changes
timeFrame: baseline, 3, 6, 9 and 12 month
measure: Differences between groups for levels of Interleukin (IL)-17, IL-8, beta-defensing 3 changes in gingival crevicular fluid
timeFrame: baseline, 3, 6, 9 and 12 month
measure: Differences between groups for levels of periodontal pathogens changes
timeFrame: baseline, 3, 6, 9 and 12 month
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Faculty of Dentistry of University of Chile
Study officials:
References:
citation: 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.