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

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Procedure: Scaling and root planing; Drug: Lactobacillus Reuteri Oral Drops

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Ghadeer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; patients received scaling and root planing using hand and ultrasonic instruments.	Procedure: Scaling and root planing; Scaling and root planing using hand and ultrasonic instruments
Active Comparator: 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.	Procedure: Scaling and root planing; Scaling and root planing using hand and ultrasonic instruments; Drug: Lactobacillus Reuteri Oral Drops; Subgingival delivery of probiotic suspension; Other Names: Scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing pocket depth	Individual acrylic stents were prepared to serve as the constant points to align the probe consistently and to reduce errors associated with probe placement. Probing pocket depth was assessed using a manual probe (UNC-15). The distance from the free gingival margin to the bottom of the pocket was recorded at six sites for each examined tooth. The probe was inserted in line with the long axis of the tooth and walked circumferentially around each surface of each tooth to detect and record the area of the deepest probe penetration. The mean probing pocket depth was obtained by summing the scores for the six sites and dividing it by six.	Baseline. 3 months. 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plaque index	This index distinguishes clearly between the severity and the location of soft debris aggregates.	Baseline, 3 and 6 months
Change in Bleeding on probing	Bleeding on probing was performed through gentle probing of the orifice of the gingival crevice. If bleeding occurs within 10 seconds, the number of positive sites is recorded and then expressed as a percentage of the number of sites examined.	Baseline, 3 and 6 months
Change in Clinical attachment level	The distance from cementoenamel junction to the bottom of the pocket was measured in the same way as described for probing	Baseline, 3 and 6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Study Director: Elbagoory, Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 6, 2019
• Study Completion (Actual): February 6, 2020

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Chronic periodontitis
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: OMP-02-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No