Clinical and Microbiological Effects of Lactobacillus Rhamnosus in Treatment of Gingivitis

NCT02809313 | Unknown Phase 2 DMC

• 1 other identifier: 1130570
• Study Type: interventional
• Target: 36
• 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 sachet as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically and microbiologically at baseline and 3-6 months after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, n=18) or control (SRP + placebo, n=18) group. The sachet will be used once per day during 3 months.

Conditions

Gingivitis

Keywords

gingivitis; probiotic; non- surgical treatment

Outcome Measures

Primary Outcomes (1)

• Differences between groups for bleeding on probing changes

  baseline, 3 month, 6 month

Secondary Outcomes (3)

• Differences between groups for gingival index

  baseline, 3 month, 6 month

• Differences between groups for detection of periodontal pathogens

  baseline, 3 month, 6 month

• Differences between groups for levels of periodontal pathogens changes

  baseline, 3 month, 6 month

Study Arms (2)

Treatment Gingivitis with Probiotic

EXPERIMENTAL

Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct probiotic containing one sachet Lactobacillus rhamnosus per day during 3 month

Dietary Supplement: Treatment Gingivitis with Probiotic

Treatment Gingivitis conventional

PLACEBO COMPARATOR

Gingivitis group of patient treated with conventional therapy (scaling, coronary polish and oral hygiene instruction) and adjunct placebo containing one sachet placebo (talc power) per day during 3 month

Other: Treatment Gingivitis conventional

Interventions

Treatment Gingivitis with Probiotic DIETARY_SUPPLEMENT

gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months

Treatment Gingivitis with Probiotic

Treatment Gingivitis conventional OTHER

gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months

Treatment Gingivitis conventional

Eligibility Criteria

• Age: 17 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Gingivitis
• Gingival index \> 1.5 (\> 10 % of the sites examined)
• Index increased bleeding on probing 10% of the sites surveyed
• Probing Depth \< 3 mm
• Systemically healthy (except for the presence of gingivitis)
• Patients who have not received periodontal treatment and before no intake of medicines such as antibiotics and / or anti-inflammatory in the last 3 months prior to the start of the study

You may not qualify if:

• Patients who develop systemic disease during the study.
• Patients who have to ingest antibiotics and / or antiinflammatories during the study.
• If you are a woman becomes pregnant during the study.

Sponsors & Collaborators

• Jorge Gamonal: lead

Study Sites (1)

Faculty of Dentistry of University of Chile

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jorge Gamonal Aravena, Proffesor

  Faculty of Dentistry of University of Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel E Bravo Bown, Proffesor

CONTACT

+5694540294; jbravo@odontologia.uchile.cl

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: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 22, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)