NCT02572531

Brief Summary

The aim of this research is to study the effect of probiotic supplements (Lactobacillus reuteri) on post-surgical complications and oral wound healing after extraction of impacted third molars.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 6, 2017

Status Verified

July 1, 2017

Enrollment Period

2 years

First QC Date

September 14, 2015

Last Update Submit

July 4, 2017

Conditions

Postoperative Complications

Keywords

Lactobacillus reuteriWound HealingThird MolarPostoperative Complications

Outcome Measures

Primary Outcomes (6)

  • Change from Baseline in Pain with VAS scale (0-10)

    VAS scale of the patient's perception of pain (0- I don´t feel any pain, 10- unbearable pain)

    Three weeks: Baseline and 3 follow ups

  • Change from Baseline in Swelling with VAS scale (0-10)

    VAS scale of the patient's perception of swelling (0- not swollen at all, 10- extremely swolen, can hardly swallow)

    Three weeks: Baseline and 3 follow ups

  • Change from Baseline in Feeding Problems with VAS scale (0-10)

    VAS scale of the patient's perception of feeding problems related to the surgery (0- I eat as usual, 10- hardly eat/liquid food ingestion)

    Three weeks: Baseline and 3 follow ups

  • Change from Baseline in Discomfort with VAS scale (0-10)

    VAS scale of the patient's perception of discomfort (0- No discomfort at all, 10- high discomfort-can not perform daily activities)

    Three weeks: Baseline and 3 follow ups

  • Frequency of Painkillers Intake after Surgery

    Frequency expressed in number of painkillers taken per day

    Three weeks: Baseline and 3 follow ups

  • Frequency of Antibiotics Intake after Surgery

    Frequency expressed in number of antibiotics taken per day

    Three weeks: Baseline and 3 follow ups

Secondary Outcomes (3)

  • Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)

    Three weeks: 3 follow-ups

  • Levels of salivary oxcytocin

    Two weeks: Baseline and two weeks after surgery

  • Microbial counts

    Two weeks: First and Second Follow-up

Study Arms (2)

L. reuteri

ACTIVE COMPARATOR

L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks

Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

Placebo

PLACEBO COMPARATOR

Placebo lozenges three times daily for 2 weeks

Dietary Supplement: Placebo

Interventions

L. reuteri DSM 17938/ATCC PTADIETARY_SUPPLEMENT

Ingestion of active lozenge three times daily for 2 weeks

L. reuteri
PlaceboDIETARY_SUPPLEMENT

Ingestion of placebo lozenge three times daily for 2 weeks

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Uncompromised general health
  • Non-smoker
  • No systemic medications (except contraceptives)
  • No recent/ongoing episode of antibiotic treatment.

You may not qualify if:

  • Any pathological condition associated with the third molars detected on radiographs prior to surgery
  • Regular consumers of probiotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Poutahidis T, Kearney SM, Levkovich T, Qi P, Varian BJ, Lakritz JR, Ibrahim YM, Chatzigiagkos A, Alm EJ, Erdman SE. Microbial symbionts accelerate wound healing via the neuropeptide hormone oxytocin. PLoS One. 2013 Oct 30;8(10):e78898. doi: 10.1371/journal.pone.0078898. eCollection 2013.

    PMID: 24205344BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Svante Twetman, Professor

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 14, 2015

First Posted

October 9, 2015

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

July 6, 2017

Record last verified: 2017-07