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

Phase 3

Completed

• Conditions: Periodontal Diseases
• Interventions: Drug: Probiotic Formula; Drug: placebo formula

• Registration Number: NCT06253988
• Lead Sponsor: Al-Azhar University

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 Timeline

• Study Start: 2023-01-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-09-30
• Study First Submitted: 2024-01-09
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group probiotic	Probiotic Formula	received conventional periodontal treatment combined with topically applied probiotic
Group placebo	placebo formula	received conventional periodontal treatment only.

Primary Outcome Measures

Name	Time	Method
quantitative assessment of A. actinomycetemcomians levels by picogram	at baseline (before treatment) used by conventional PCR	Microbiological evaluation by picogram
Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm	at base line , 1 , 3 , 6 months	Clinical evaluation mm
Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm	at base line , 1 , 3 , 6 months	Clinical evaluation by "mm"

Secondary Outcome Measures

Name	Time	Method
quantitative assessment of A. actinomycetemcomians levels by picogram	baseline ,1 ,3 and 6 months	microbiological by picogram

Trial Locations

Locations (1)

Alazhar university ,faculty of Dental Medicine; 🇪🇬 Assiut, Egypt