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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Al-Azhar University
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- quantitative assessment of A. actinomycetemcomians levels by picogram
Study Overview
Brief Summary
the research highlight the effectiveness of probiotics as adjuncts to SRP in the treatment of periodontitis stage III grade C molar-incisor pattern
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 28 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •patients have periodontitis stage III grade C molar-incisor pattern .
Exclusion Criteria
- •Pregnant or nursing women,
- •patients received periodontal therapy,
- •systemic antimicrobials or anti-inflammatory drugs in the last six
- •patients with unacceptable oral hygiene
Arms & Interventions
Group probiotic
received conventional periodontal treatment combined with topically applied probiotic
Intervention: Probiotic Formula (Drug)
Group placebo
received conventional periodontal treatment only.
Intervention: placebo formula (Drug)
Outcomes
Primary Outcomes
quantitative assessment of A. actinomycetemcomians levels by picogram
Time Frame: at baseline (before treatment) used by conventional PCR
Microbiological evaluation by picogram
Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm
Time Frame: at base line , 1 , 3 , 6 months
Clinical evaluation mm
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
- quantitative assessment of A. actinomycetemcomians levels by picogram(baseline ,1 ,3 and 6 months)
Investigators
Shaymaa Hussein Rafat Kotb
Assistant lecturere of oral medicine ,periodontology departement at sphinx university
Sphinx university