NCT04697199

Brief Summary

Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1 year

First QC Date

December 31, 2020

Last Update Submit

January 5, 2021

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in Plaque index

    Baseline, 3 and 6 months

  • Change in Bleeding on probing

    Baseline, 3 and 6 months

  • Change in Clinical attachment level

    Baseline, 3 and 6 months

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Procedure: Scaling and root planing

Probiotic group

ACTIVE COMPARATOR

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.

Drug: Lactobacillus Reuteri Oral DropsProcedure: Scaling and root planing

Interventions

Lactobacillus Reuteri Oral DropsDRUG

Subgingival delivery of probiotic suspension

Also known as: Scaling and root planing
Probiotic group
Scaling and root planingPROCEDURE

Scaling and root planing using hand and ultrasonic instruments

Placebo groupProbiotic group

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghadeer

Tanta, Egypt

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot Planing

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive Dentistry

Study Officials

  • Elbagoory

    Tanta University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 6, 2021

Study Start

September 1, 2018

Primary Completion

September 6, 2019

Study Completion

February 6, 2020

Last Updated

January 6, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)