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

NCT06253988 | Completed Phase 3 DMC

• 1 other identifier: AUAREC202300010-2
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Diseases

Keywords

Periodontitis; Agg. actinomycetemcomitans; JP2 genotype; PCR; local delivery drug; probiotics

Outcome Measures

Primary Outcomes (3)

• quantitative assessment of A. actinomycetemcomians levels by picogram

  Microbiological evaluation by picogram

  at baseline (before treatment) used by conventional PCR

• Assessment of clinical periodontal parameter : Probing pocket Depth (PPD) by mm

  Clinical evaluation mm

  at base line , 1 , 3 , 6 months

• Assessment of clinical periodontal parameter : Clinical Attachment Level (CAL) by mm

  Clinical evaluation by "mm"

  at base line , 1 , 3 , 6 months

Secondary Outcomes (1)

• quantitative assessment of A. actinomycetemcomians levels by picogram

  baseline ,1 ,3 and 6 months

Study Arms (2)

Group probiotic

ACTIVE COMPARATOR

received conventional periodontal treatment combined with topically applied probiotic

Drug: Probiotic Formula

Group placebo

PLACEBO COMPARATOR

received conventional periodontal treatment only.

Drug: placebo formula

Interventions

Probiotic Formula DRUG

intra-pocket formula (local delivery drug)

Also known as: A mixture of Lactobacillus brevis and Lactobacillus plantarum

Group probiotic

placebo formula DRUG

intra-pocket formula (local delivery drug)

Also known as: placebo

Group placebo

Eligibility Criteria

• Age: 10 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients have periodontitis stage III grade C molar-incisor pattern .

You may not qualify if:

• Pregnant or nursing women,
• smokers,
• patients received periodontal therapy,
• systemic antimicrobials or anti-inflammatory drugs in the last six
• patients with unacceptable oral hygiene

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Alazhar university ,faculty of Dental Medicine

Asyut, 0000, Egypt

Location

Related Links

• Orchid
• National library of Medicine
• web of science

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ibrahim H Ibrahim, Ass.prof.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Mohamed A EL-Mokhtar, Prof

  Assiut University

  STUDY DIRECTOR

• Mohamed F Edrees, prof.

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

• Heba A Hammad, Ass.prof

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturere of oral medicine ,periodontology departement at sphinx university

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 12, 2024
• Study Start: January 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: September 30, 2023
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: 1 month
• Access Criteria: DOI: 10.21203/rs.3.rs-3837892/v1

Locations

EG (1)