NCT02403960

Brief Summary

Aim: to evaluate the additional effects of the 12 weeks usage of a Streptococcus containing probiotic tablet after scaling and rootplaning compared to a placebo tablet. Materials and methods: 48 periodontitis patients were included in this double-blind, placebo-controlled trial. After scaling and rootplaning, they were given patients used either a placebo (SRP) or probiotic tablet (SRP + P), 2 times a day for 12 weeks. Clinical and microbiological parameters were studied recorded up to 24 weeks after scaling and rootplaning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 31, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

5 months

First QC Date

March 16, 2015

Last Update Submit

October 30, 2015

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • probing pocket depth

    24 weeks

Secondary Outcomes (6)

  • Recession

    24 weeks

  • clinical attachment level

    24 weeks

  • Bleeding on probing

    24 weeks

  • Gingival Index

    24 weeks

  • Plaque Index

    24 weeks

  • +1 more secondary outcomes

Study Arms (2)

probiotic

ACTIVE COMPARATOR

The participants of the probiotic group were asked to let a probiotic tablet dissolve on their tongue 2 times a day for 3 months.

Dietary Supplement: probiotic

placebo

PLACEBO COMPARATOR

The participants of the control group were asked to let a placebo tablet dissolve on their tongue 2 times a day for 3 months.

Dietary Supplement: placebo

Interventions

probioticDIETARY_SUPPLEMENT

the patients used probiotic tablets in addition to scaling and root planning

probiotic
placeboDIETARY_SUPPLEMENT

the patients used placebo tablets in addition to scaling and root planning

placebo

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy, non-institutionalized male or female patients,
  • at least 35 years of age,
  • a minimum of 3 natural teeth in every quadrant and
  • previously untreated moderate to severe periodontitis

You may not qualify if:

  • received antibiotics for any purpose within 6 months prior to entering the study or suffering from a disease condition that would typically require antibiotic prophylaxis before dental treatment,
  • a history of diabetes, rheumatic fever, liver or kidney disease, neurological deficiencies, or use of medication which may affect periodontal tissue (for example: phenytoin, cyclosporin, chronic use of non-steroidal anti-inflammatory drugs),
  • pregnancy,
  • acute oral lesions or necrotizing ulcerative periodontitis and
  • dental personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

Related Publications (1)

  • Laleman I, Yilmaz E, Ozcelik O, Haytac C, Pauwels M, Herrero ER, Slomka V, Quirynen M, Alkaya B, Teughels W. The effect of a streptococci containing probiotic in periodontal therapy: a randomized controlled trial. J Clin Periodontol. 2015 Nov;42(11):1032-41. doi: 10.1111/jcpe.12464. Epub 2015 Nov 29.

    PMID: 26427036DERIVED

MeSH Terms

Conditions

Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Onur Ozcelik

    CU

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 31, 2015

Study Start

June 1, 2010

Primary Completion

November 1, 2010

Study Completion

May 1, 2011

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

TU(1)