Probiotics Effects to Initial Periodontal Treatment

NCT05408364 | Completed

• 1 other identifier: MAR-2011-03-30-24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.

Conditions

Chronic Periodontitis

Keywords

bifidobacterium; chronic periodontitis; dental scaling; probiotic; root planing

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.

  28 days

Secondary Outcomes (5)

• Gingival Index

  28 days

• Plaque Index

  28 days

• Bleeding on probing

  28 days

• Clinical attachment level

  28 days

• microbiological parameters

  28 days

Study Arms (2)

Natural yoghurt

PLACEBO COMPARATOR

SRP+nature yogurt (Danone® yogurt, Luleburgaz, Türkiye)

Dietary Supplement: probiotic or natural yoghurt; Procedure: SRP

Probiotic yoghurt

EXPERIMENTAL

SRP+probiotic containing yogurt (Danone Activia® Plain, Luleburgaz, Türkiye)

Dietary Supplement: probiotic or natural yoghurt; Procedure: SRP

Interventions

probiotic or natural yoghurt DIETARY_SUPPLEMENT

Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt

Natural yoghurt; Probiotic yoghurt

SRP PROCEDURE

Scalling and root planing

Natural yoghurt; Probiotic yoghurt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic periodontitis patients with radiographically detected horizontal bone loss
• the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD\<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
• previously untreated periodontitis, systemically healthy

You may not qualify if:

• Systemic diseases
• Antibiotics and anti-inflammatory drugs within 3 months before the study
• Untreated caries lesions or local retention factors
• Allergic reactions to lactose or fermented milk products
• Previous probiotic supplements in diet
• Smoking
• Pregnancy

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bahar Kuru, Prof. Dr.

  Marmara University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

• Hafize Öztürk Özener, Dr.

  Marmara University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Individuals and doctor were blinded to the study groups allocation. Before statistical analysis, the blind study coordinator broke the code to allocate the indivuals to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 7, 2022
• Study Start: April 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 7, 2022

Record last verified: 2011-03

Locations

TU (1)