NCT03499184

Adjunctive Probiotics in Chronic Periodontitis

Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ziauddin Hospital · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	P Flor locally delivered	Locally delivered Lactobacillus reuteri 1.2 CFU per gram
DIETARY_SUPPLEMENT	P Flor systemically administered	Systemically administered Lactobacillus reuteri 1.2 CFU per gram
DRUG	Amoxil 500 mg Oral Capsule	Systemically administered Amoxil 500 mg thrice daily
DRUG	Flagyl 400 mg Tablet	Systemically administered Metronidazole 400 mg twice daily

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-09-01
• Completion: 2018-10-01
• First posted: 2018-04-17
• Last updated: 2019-03-12

Locations

1 site across 1 country: Pakistan