Adjunctive Probiotics in Chronic Periodontitis

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Pakistan

Ziauddin Dental College

Karachi, Sindh, Pakistan, 75600

Sponsors and Collaborators

Ziauddin Hospital

More Information

• Responsible Party: Sana Ikram, MPhil Trainee, Doctor, Lecturer, MPhil trainee, Ziauddin Hospital
• ClinicalTrials.gov Identifier: NCT03499184
• Other Study ID Numbers: 0220817SIOB
• First Posted: April 17, 2018
• Last Update Posted: March 12, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Periodontitis; Chronic Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Metronidazole; Amoxicillin; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents