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

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697199
• Other study ID #: OMP-02-18
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2018
• Est. completion date: February 6, 2020

Study information

• Verified date: January 2021
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 6, 2020
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• Lactobacillus Reuteri Oral Drops
Subgingival delivery of probiotic suspension

Procedure:
• Scaling and root planing
Scaling and root planing using hand and ultrasonic instruments

Locations

Country	Name	City	State
Egypt	Ghadeer	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Plaque index	This index distinguishes clearly between the severity and the location of soft debris aggregates.	Baseline, 3 and 6 months
Secondary	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
Secondary	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