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

Tanta University

Status and phase: Completed; Phase 1

Conditions: Chronic Periodontitis

Treatments: Procedure: Scaling and root planing; Drug: Lactobacillus Reuteri Oral Drops

Study type: Interventional

Funder types: Other

Identifiers

NCT04697199

OMP-02-18

Details and patient eligibility

About

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

Full description

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.

Enrollment: 12 patients

Sex: All

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Procedure: Scaling and root planing

Probiotic group

Active Comparator group

Description:

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.

Treatment:

Procedure: Scaling and root planing

Drug: Lactobacillus Reuteri Oral Drops