Adjunctive Probiotics in Chronic Periodontitis

NCT ID: NCT03499184

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-10-01

Brief Summary

This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.

Detailed Description

In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.

Conditions

Chronic Periodontitis; Probiotics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Local Probiotics

P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks

Group Type: EXPERIMENTAL

P Flor locally delivered

Intervention Type: DIETARY_SUPPLEMENT

Locally delivered Lactobacillus reuteri 1.2 CFU per gram

Systemic Probiotics

P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks

Group Type: EXPERIMENTAL

P Flor systemically administered

Intervention Type: DIETARY_SUPPLEMENT

Systemically administered Lactobacillus reuteri 1.2 CFU per gram

Systemic Antibiotics

Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days

Group Type: ACTIVE_COMPARATOR

Amoxil 500 mg Oral Capsule

Intervention Type: DRUG

Systemically administered Amoxil 500 mg thrice daily

Flagyl 400 mg Tablet

Intervention Type: DRUG

Systemically administered Metronidazole 400 mg twice daily

Interventions

P Flor locally delivered

Locally delivered Lactobacillus reuteri 1.2 CFU per gram

Intervention Type: DIETARY_SUPPLEMENT

P Flor systemically administered

Systemically administered Lactobacillus reuteri 1.2 CFU per gram

Intervention Type: DIETARY_SUPPLEMENT

Amoxil 500 mg Oral Capsule

Systemically administered Amoxil 500 mg thrice daily

Intervention Type: DRUG

Flagyl 400 mg Tablet

Systemically administered Metronidazole 400 mg twice daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
• Patients with age ≥30 years.

Exclusion Criteria

• Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
• Pregnant and lactating females.
• Patients with habits of smoking, chewing tobacco and alcohol consumption.
• Patients on local or systemic antibiotic treatment.
• Patients with any systemic diseases.
• Patients with the history of any periodontal therapy within last 6 months.
• Patients undergoing orthodontic treatment.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziauddin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sana Ikram, MPhil Trainee

Doctor, Lecturer, MPhil trainee

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ziauddin Dental College

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

0220817SIOB

Identifier Type: -

Identifier Source: org_study_id