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

Periodontal Diseases Clinical Trial

— RCT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06253988
• Other study ID #: AUAREC202300010-2
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 30, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Probiotic Formula
intra-pocket formula (local delivery drug)
• placebo formula
intra-pocket formula (local delivery drug)

Locations

Country	Name	City	State
Egypt	Alazhar university ,faculty of Dental Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

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

External Links

•   National library of Medicine
•   Orchid
•   web of science