Adjunctive Probiotics in Chronic Periodontitis

Ziauddin Hospital

Status: Completed

Conditions: Chronic Periodontitis; Probiotics

Treatments: Drug: Flagyl 400 mg Tablet; Dietary Supplement: P Flor systemically administered; Dietary Supplement: P Flor locally delivered; Drug: Amoxil 500 mg Oral Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03499184

0220817SIOB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

Local Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: P Flor locally delivered

Systemic Probiotics

Experimental group

Description:

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

Treatment:

Dietary Supplement: P Flor systemically administered

Systemic Antibiotics

Active Comparator group

Description:

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

Treatment:

Drug: Flagyl 400 mg Tablet

Drug: Amoxil 500 mg Oral Capsule