Adjunctive Probiotics in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499184
• Other study ID #: 0220817SIOB
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: March 2019
• Source: Ziauddin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis
• Probiotics

Intervention

Dietary Supplement:
• P Flor locally delivered
Locally delivered Lactobacillus reuteri 1.2 CFU per gram
• P Flor systemically administered
Systemically administered Lactobacillus reuteri 1.2 CFU per gram

Drug:
• Amoxil 500 mg Oral Capsule
Systemically administered Amoxil 500 mg thrice daily
• Flagyl 400 mg Tablet
Systemically administered Metronidazole 400 mg twice daily

Locations

Country	Name	City	State
Pakistan	Ziauddin Dental College	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Change in Gingival index (GI)	Gingival color texture and inflammation will be recorded.	Baseline, 3, 6, 9 and 12 weeks