Effect of Probiotics on Periodontitis Stage III Grade C Molar-incisor Pattern (RCT)

February 9, 2024 updated by: Shaymaa Hussein Rafat Kotb, Al-Azhar University

Evaluating the Effect of a Mixture of Lactobacillus Brevis and Lactobacillus Plantarum on the Management of Periodontitis Stage III Grade C Molar-incisor Pattern in Egyptian Patients ( Randomize Control Trial)

the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background data : Periodontitis is a common disease that represents a public health problem. Aggregatibacter actinomycetemcomitans (A. a ) especially the JP2 genotype plays a major role in the pathogenesis of periodontitis. The aim of this study is to evaluate the effect of topically applied probiotics on the management of periodontitis stage III grade C molar-incisor pattern.

Methods: Sixty-five patients having periodontitis stage III grade C molar-incisor pattern. Screening for A. actinomycetemcomians (A.a) and the JP2 genotype was done using conventional polymerase chain reaction (PCR). Patients positive for (A. a) were randomly divided into two groups. Group I: received conventional periodontal treatment combined with topically applied probiotic, while Group II: received conventional periodontal treatment only. Both groups were evaluated microbiologically and clinically. Quantitative assessment of A. a levels was done by real time PCR (qPCR) at baseline as well as one week, 4 weeks, and 12 weeks after treatment. Clinical parameters were assessed before treatment as well as 3,6 and 9 months after treatment.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 0000
        • Alazhar university ,faculty of Dental Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients have periodontitis stage III grade C molar-incisor pattern .

Exclusion Criteria:

  • Pregnant or nursing women,
  • smokers,
  • patients received periodontal therapy,
  • systemic antimicrobials or anti-inflammatory drugs in the last six
  • patients with unacceptable oral hygiene

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group probiotic
received conventional periodontal treatment combined with topically applied probiotic
Drug: Probiotic Formula
intra-pocket formula (local delivery drug)
Other Names:
  • A mixture of Lactobacillus brevis and Lactobacillus plantarum
Placebo Comparator: Group placebo
received conventional periodontal treatment only.
Drug: placebo formula
intra-pocket formula (local delivery drug)
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative assessment of A. actinomycetemcomians levels by picogram
Time Frame: at baseline (before treatment) used by conventional PCR
Microbiological evaluation by picogram
at baseline (before treatment) used by conventional PCR
Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm
Time Frame: at base line , 1 , 3 , 6 months
Clinical evaluation mm
at base line , 1 , 3 , 6 months
Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm
Time Frame: at base line , 1 , 3 , 6 months
Clinical evaluation by "mm"
at base line , 1 , 3 , 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quantitative assessment of A. actinomycetemcomians levels by picogram
Time Frame: baseline ,1 ,3 and 6 months
microbiological by picogram
baseline ,1 ,3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Ibrahim H Ibrahim, Ass.prof., Alazhar University
  • Study Director: Mohamed A EL-Mokhtar, Prof, Assiut University
  • Principal Investigator: Mohamed F Edrees, prof., Alazhar University
  • Study Director: Heba A Hammad, Ass.prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUAREC202300010-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Effect of probiotics on periodontitis stage III grade C molar-incisor pattern

IPD Sharing Time Frame

1 month

IPD Sharing Access Criteria

DOI: 10.21203/rs.3.rs-3837892/v1

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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