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NCT Number: NCT06253988

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

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

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Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

10 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alazhar university ,faculty of Dental Medicine

Asyut, 0000, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic Formula

Drug

intra-pocket formula (local delivery drug)

Other names: A mixture of Lactobacillus brevis and Lactobacillus plantarum

placebo formula

Drug

intra-pocket formula (local delivery drug)

Other names: placebo

Primary outcomes

  1. quantitative assessment of A. actinomycetemcomians levels by picogram

    Time frame: at baseline (before treatment) used by conventional PCR

    Microbiological evaluation by picogram

  2. Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm

    Time frame: at base line , 1 , 3 , 6 months

    Clinical evaluation mm

  3. Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm

    Time frame: at base line , 1 , 3 , 6 months

    Clinical evaluation by "mm"

Secondary outcomes

  1. quantitative assessment of A. actinomycetemcomians levels by picogram

    Time frame: baseline ,1 ,3 and 6 months

    microbiological by picogram

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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)

Acronym: RCT

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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