The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-02-06

Brief Summary

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Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

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Detailed Description

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The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).

Material and Methods: Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo group

patients received scaling and root planing using hand and ultrasonic instruments.

Group Type PLACEBO_COMPARATOR

Scaling and root planing

Intervention Type PROCEDURE

Scaling and root planing using hand and ultrasonic instruments

Probiotic group

patients received SRP and by using blunt syringe, subgingival delivery of 1ml of probiotic suspension was applied to these sites at baseline (immediately after SRP), one, two and four weeks. Periodontal dressing was applied after placement of the drug.

After placement of the drug, patients were instructed to keep away from chewing hard or sticky food, brushing near the treated areas, or using any interdental aids for 24 hours.

Group Type ACTIVE_COMPARATOR

Lactobacillus Reuteri Oral Drops

Intervention Type DRUG

Subgingival delivery of probiotic suspension

Scaling and root planing

Intervention Type PROCEDURE

Scaling and root planing using hand and ultrasonic instruments

Interventions

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Lactobacillus Reuteri Oral Drops

Subgingival delivery of probiotic suspension

Intervention Type DRUG

Scaling and root planing

Scaling and root planing using hand and ultrasonic instruments

Intervention Type PROCEDURE

Other Intervention Names

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Scaling and root planing

Eligibility Criteria

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Inclusion Criteria

1. Patients with good systemic health.
2. Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
3. Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
4. No gingival recession.

Exclusion Criteria

1. Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
2. Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
3. Patients who are allergic to lactate products.

Minimum Eligible Age

35 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No