Clinical trial NCT06253988: Effect of Probiotics on Periodontitis Stage III Grade C Molar-incisor Pattern
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontal Diseases
Keywords: Periodontitis
Agg. actinomycetemcomitans
JP2 genotype
PCR
local delivery drug
probiotics
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 65
Sex: ALL
Minimum age (years): 10
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: quantitative assessment of A. actinomycetemcomians levels by picogram
timeFrame: at baseline (before treatment) used by conventional PCR
measure: Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm
timeFrame: at base line , 1 , 3 , 6 months
measure: Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm
timeFrame: at base line , 1 , 3 , 6 months
Secondary outcomes:
measure: quantitative assessment of A. actinomycetemcomians levels by picogram
timeFrame: baseline ,1 ,3 and 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar university ,faculty of Dental Medicine
Study officials:
affiliation: Al-Azhar University
name: Ibrahim H Ibrahim, Ass.prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Mohamed A EL-Mokhtar, Prof
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Mohamed F Edrees, prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: Heba A Hammad, Ass.prof
role: STUDY_DIRECTOR
References: