Adjunctive Probiotics in Chronic Periodontitis

NCT03499184 | Completed

• 1 other identifier: 0220817SIOB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis; Probiotics

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Change in the Plaque index (PI)

  Baseline, 3, 6, 9 and 12 weeks

• Change in Gingival index (GI)

  Baseline, 3, 6, 9 and 12 weeks

Study Arms (3)

Local Probiotics

EXPERIMENTAL

P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks

Dietary Supplement: P Flor locally delivered

Systemic Probiotics

EXPERIMENTAL

P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks

Dietary Supplement: P Flor systemically administered

Systemic Antibiotics

ACTIVE COMPARATOR

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; Drug: Flagyl 400 mg Tablet

Interventions

P Flor locally delivered DIETARY_SUPPLEMENT

Locally delivered Lactobacillus reuteri 1.2 CFU per gram

Local Probiotics

P Flor systemically administered DIETARY_SUPPLEMENT

Systemically administered Lactobacillus reuteri 1.2 CFU per gram

Systemic Probiotics

Amoxil 500 mg Oral Capsule DRUG

Systemically administered Amoxil 500 mg thrice daily

Systemic Antibiotics

Flagyl 400 mg Tablet DRUG

Systemically administered Metronidazole 400 mg twice daily

Systemic Antibiotics

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
• Patients with age ≥30 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziauddin Hospital: lead

Study Sites (1)

Ziauddin Dental College

Karachi, Sindh, 75600, Pakistan

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Amoxicillin; Metronidazole; Tablets

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Lecturer, MPhil trainee

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 17, 2018
• Study Start: November 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

PA (1)