Adjunctive Probiotics in Chronic Periodontitis

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

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.

Study Overview

• Status: Completed
• Conditions: Probiotics; Chronic Periodontitis
• Intervention / Treatment: Dietary supplement: P Flor locally delivered; Dietary supplement: P Flor systemically administered; Drug: Amoxil 500 mg Oral Capsule; Drug: Flagyl 400 mg Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75600
      • Ziauddin Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Local Probiotics; P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks	Dietary supplement: P Flor locally delivered; Locally delivered Lactobacillus reuteri 1.2 CFU per gram
Experimental: Systemic Probiotics; P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks	Dietary supplement: P Flor systemically administered; Systemically administered Lactobacillus reuteri 1.2 CFU per gram
Active Comparator: Systemic Antibiotics; Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in periodontal pocket depth (PPD)	It is the distance from tip of free gingival margin to the base of pocket	Baseline, 3, 6, 9 and 12 weeks
Change in clinical attachment level (CAL)	It is the distance from cementoenamel junction to the base of the pocket around the tooth	Baseline, 3, 6, 9 and 12 weeks
Change in bacterial load of Porphyromonas gingivalis	Bacterial count or the quantity of porphyromonas gingivalis in the sample	Baseline and 12 weeks after completion of trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Plaque index (PI)	How much surface of tooth is covered by the plaque will be recorded.	Baseline, 3, 6, 9 and 12 weeks
Change in Gingival index (GI)	Gingival color texture and inflammation will be recorded.	Baseline, 3, 6, 9 and 12 weeks

Collaborators and Investigators

• Sponsor: Ziauddin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: April 3, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Amoxicillin
• Other Study ID Numbers: 0220817SIOB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No