NCT02597192

Brief Summary

Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis. Materials and methods: In this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8 weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

6 months

First QC Date

October 30, 2015

Last Update Submit

November 3, 2015

Conditions

Gingivitis

Keywords

gingivitisgingival inflammationprobioticsBacillus

Outcome Measures

Primary Outcomes (1)

  • gingival index scores

    8weeks

Secondary Outcomes (1)

  • plaque index scores

    8weeks

Study Arms (2)

Active test group

ACTIVE COMPARATOR

probiotic oral hygiene products with Bacillus (PIP, Chrisal)

Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)

Placebo group

PLACEBO COMPARATOR

oral hygiene products without Bacillus

Other: oral hygiene products without Bacillus

Interventions

probiotic oral hygiene products with Bacillus (PIP, Chrisal)OTHER

products with Bacillus probiotics

Active test group
oral hygiene products without BacillusOTHER

products without Bacillus

Placebo group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with plaque-induced gingivitis
  • a pocket probing depth not more than 5 mm
  • at least 20 natural teeth
  • no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months

You may not qualify if:

  • patients with hematologic disorders, or other systemic illness
  • pregnant and lactating females
  • patients undergoing orthodontic treatment
  • those with smoking habits were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Interventions

PIP protein, human

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Onur Ozcelik, Professor

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 5, 2015

Study Start

June 1, 2014

Primary Completion

December 1, 2014

Study Completion

October 1, 2015

Last Updated

November 5, 2015

Record last verified: 2015-11

Locations

TU(1)