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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Lactobacillus Reuteri Oral Drops
Scaling and root planing
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring Chronic periodontitis

Eligibility Criteria

35 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ghadeer

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

Probiotic group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Plaque index
This index distinguishes clearly between the severity and the location of soft debris aggregates.
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.
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

Full Information

First Posted
December 31, 2020
Last Updated
January 5, 2021
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04697199
Brief Title
The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
Official Title
The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 6, 2019 (Actual)
Study Completion Date
February 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Chronic periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
patients received scaling and root planing using hand and ultrasonic instruments.
Arm Title
Probiotic group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus Reuteri Oral Drops
Other Intervention Name(s)
Scaling and root planing
Intervention Description
Subgingival delivery of probiotic suspension
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Scaling and root planing using hand and ultrasonic instruments
Primary Outcome Measure Information:
Title
Change in Probing pocket depth
Description
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.
Time Frame
Baseline. 3 months. 6 months
Secondary Outcome Measure Information:
Title
Change in Plaque index
Description
This index distinguishes clearly between the severity and the location of soft debris aggregates.
Time Frame
Baseline, 3 and 6 months
Title
Change in Bleeding on probing
Description
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.
Time Frame
Baseline, 3 and 6 months
Title
Change in Clinical attachment level
Description
The distance from cementoenamel junction to the bottom of the pocket was measured in the same way as described for probing
Time Frame
Baseline, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with good systemic health. Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm. Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene. No gingival recession. Exclusion Criteria: Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months. 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). Patients who are allergic to lactate products.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elbagoory
Organizational Affiliation
Tanta University
Official's Role
Study Director
Facility Information:
Facility Name
Ghadeer
City
Tanta
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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