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

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2023-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group probiotic

received conventional periodontal treatment combined with topically applied probiotic

Group Type ACTIVE_COMPARATOR

Probiotic Formula

Intervention Type DRUG

intra-pocket formula (local delivery drug)

Group placebo

received conventional periodontal treatment only.

Group Type PLACEBO_COMPARATOR

placebo formula

Intervention Type DRUG

intra-pocket formula (local delivery drug)

Interventions

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Probiotic Formula

intra-pocket formula (local delivery drug)

Intervention Type DRUG

placebo formula

intra-pocket formula (local delivery drug)

Intervention Type DRUG

Other Intervention Names

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A mixture of Lactobacillus brevis and Lactobacillus plantarum placebo

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes