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Adjunctive Probiotics in Chronic Periodontitis

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ClinicalTrials.gov Identifier: NCT03499184
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Sana Ikram, MPhil Trainee, Ziauddin Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Probiotics Dietary Supplement: P Flor locally delivered Dietary Supplement: P Flor systemically administered Drug: Amoxil 500 mg Oral Capsule Drug: Flagyl 400 mg Tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : October 1, 2018

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




Primary Outcome Measures :
  1. Change in periodontal pocket depth (PPD) [ Time Frame: Baseline, 3, 6, 9 and 12 weeks ]
    It is the distance from tip of free gingival margin to the base of pocket

  2. Change in clinical attachment level (CAL) [ Time Frame: Baseline, 3, 6, 9 and 12 weeks ]
    It is the distance from cementoenamel junction to the base of the pocket around the tooth

  3. Change in bacterial load of Porphyromonas gingivalis [ Time Frame: Baseline and 12 weeks after completion of trial ]
    Bacterial count or the quantity of porphyromonas gingivalis in the sample


Secondary Outcome Measures :
  1. Change in the Plaque index (PI) [ Time Frame: Baseline, 3, 6, 9 and 12 weeks ]
    How much surface of tooth is covered by the plaque will be recorded.

  2. Change in Gingival index (GI) [ Time Frame: Baseline, 3, 6, 9 and 12 weeks ]
    Gingival color texture and inflammation will be recorded.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499184


Locations
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Pakistan
Ziauddin Dental College
Karachi, Sindh, Pakistan, 75600
Sponsors and Collaborators
Ziauddin Hospital

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Responsible Party: Sana Ikram, MPhil Trainee, Doctor, Lecturer, MPhil trainee, Ziauddin Hospital
ClinicalTrials.gov Identifier: NCT03499184     History of Changes
Other Study ID Numbers: 0220817SIOB
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Amoxicillin
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents