Effect of Probiotics as Supplement to Non-surgical Periodontal Treatment

NCT ID: NCT05518747

Last Updated: 2022-11-02

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

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The present study is a double-blinded randomized clinical trial with a duration of 12 weeks.

Detailed Description

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The present study is a double-blinded randomized clinical trial with a duration of 12 weeks

. 60 patients with periodontitis stage 2-3, grade B-C, generalized will be allocated in the test (probiotic) and the control (placebo) group at baseline.

The intervention is non-surgical periodontal treatment, which will be applied at baseline and followed for 12 weeks.

Clinical measurements and sampling will be performed at baseline, week 6 and week 12.

Primary endpoint: Changes in microbial composition.

Secondary endpoints: Changes in clinical and immunological parameters

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blinded randomized clinical trial with a test and placebo group
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Computerized randomization only known to the principal investigator, who are not directly involved in data collection or data analysis

Study Groups

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Probiotic

In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.

Placebo

In this group participants will receive non-surgical periodontal treatment at baseline, which will for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.

Interventions

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Probiotic

In this group participants will receive probiotic supplements twice a day (morning and evening) for a period of 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

In this group participants will receive placebo twice a day (morning and evening) for at period of 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Periodontitis stage 2-3, Grade B-C, generalized

Exclusion Criteria

* • Use of systemic antibiotics within the latest three months.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Daniel Belstrøm, DDS, PhD

Associate professor, dr. odont., PhD, DDS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Copenhagen, Department of Odontology

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Daniel Belstrøm, DDS, PhD

Role: primary

+45 21300580

Merete Markvart, DDS, PhD

Role: backup

+45 35 33 77 65

Other Identifiers

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UCPH_01_007

Identifier Type: -

Identifier Source: org_study_id

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