Adjunctive Probiotics in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis, Probiotics
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
P Flor locally delivered
P Flor systemically administered
Amoxil 500 mg Oral Capsule
Flagyl 400 mg Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
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.
Sites / Locations
- Ziauddin Dental College
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Local Probiotics
Systemic Probiotics
Systemic Antibiotics
Arm Description
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
Outcomes
Primary Outcome Measures
Change in periodontal pocket depth (PPD)
It is the distance from tip of free gingival margin to the base of pocket
Change in clinical attachment level (CAL)
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Change in bacterial load of Porphyromonas gingivalis
Bacterial count or the quantity of porphyromonas gingivalis in the sample
Secondary Outcome Measures
Change in the Plaque index (PI)
How much surface of tooth is covered by the plaque will be recorded.
Change in Gingival index (GI)
Gingival color texture and inflammation will be recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03499184
Brief Title
Adjunctive Probiotics in Chronic Periodontitis
Official Title
Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ziauddin Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Probiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local Probiotics
Arm Type
Experimental
Arm Description
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
Arm Title
Systemic Probiotics
Arm Type
Experimental
Arm Description
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
Arm Title
Systemic Antibiotics
Arm Type
Active Comparator
Arm Description
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
P Flor locally delivered
Intervention Description
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
Intervention Type
Dietary Supplement
Intervention Name(s)
P Flor systemically administered
Intervention Description
Systemically administered Lactobacillus reuteri 1.2 CFU per gram
Intervention Type
Drug
Intervention Name(s)
Amoxil 500 mg Oral Capsule
Intervention Description
Systemically administered Amoxil 500 mg thrice daily
Intervention Type
Drug
Intervention Name(s)
Flagyl 400 mg Tablet
Intervention Description
Systemically administered Metronidazole 400 mg twice daily
Primary Outcome Measure Information:
Title
Change in periodontal pocket depth (PPD)
Description
It is the distance from tip of free gingival margin to the base of pocket
Time Frame
Baseline, 3, 6, 9 and 12 weeks
Title
Change in clinical attachment level (CAL)
Description
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Time Frame
Baseline, 3, 6, 9 and 12 weeks
Title
Change in bacterial load of Porphyromonas gingivalis
Description
Bacterial count or the quantity of porphyromonas gingivalis in the sample
Time Frame
Baseline and 12 weeks after completion of trial
Secondary Outcome Measure Information:
Title
Change in the Plaque index (PI)
Description
How much surface of tooth is covered by the plaque will be recorded.
Time Frame
Baseline, 3, 6, 9 and 12 weeks
Title
Change in Gingival index (GI)
Description
Gingival color texture and inflammation will be recorded.
Time Frame
Baseline, 3, 6, 9 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Ziauddin Dental College
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75600
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Adjunctive Probiotics in Chronic Periodontitis
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