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

NCT ID: NCT02839408

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Periodontal treatment, talc powder tab

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

Group Type PLACEBO_COMPARATOR

Talc powder

Intervention Type OTHER

Sachet containing talc powder and tablet containing talc powder

Periodontal treatment Scaling and root planning

Intervention Type PROCEDURE

Periodontal treatment, Probitic

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

Group Type EXPERIMENTAL

Lactobacillus rhamnosus SP1

Intervention Type DIETARY_SUPPLEMENT

Sachet containing Lactobacillus rhamnosus SP1

Periodontal treatment Scaling and root planning

Intervention Type PROCEDURE

Periodontal treatment, Antibiotic

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

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Tablet containing 500mg Azithromicyn

Periodontal treatment Scaling and root planning

Intervention Type PROCEDURE

Interventions

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Lactobacillus rhamnosus SP1

Sachet containing Lactobacillus rhamnosus SP1

Intervention Type DIETARY_SUPPLEMENT

Azithromycin

Tablet containing 500mg Azithromicyn

Intervention Type DRUG

Talc powder

Sachet containing talc powder and tablet containing talc powder

Intervention Type OTHER

Periodontal treatment Scaling and root planning

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Jorge Gamonal

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

Site Status

Countries

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Chile

References

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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.

Reference Type DERIVED
PMID: 33413320 (View on PubMed)

Other Identifiers

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FONDECYT 1130570.b

Identifier Type: -

Identifier Source: org_study_id

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