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

Al-Azhar University

Status and phase: Completed; Phase 3

Conditions: Periodontal Diseases

Treatments: Drug: placebo formula; Drug: Probiotic Formula

Study type: Interventional

Funder types: Other

Identifiers

NCT06253988

AUAREC202300010-2

Details and patient eligibility

About

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

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 10 to 28 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups, including a placebo group

Group probiotic

Active Comparator group

Description:

received conventional periodontal treatment combined with topically applied probiotic

Treatment:

Drug: Probiotic Formula

Group placebo

Placebo Comparator group

Description:

received conventional periodontal treatment only.

Treatment:

Drug: placebo formula