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Effect of Probiotics on Pain and Oral Wound Healing After Third Molar Surgery (PROVIS)

Primary Purpose

Postoperative Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
L. reuteri DSM 17938/ATCC PTA
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Complications focused on measuring Lactobacillus reuteri, Wound Healing, Third Molar, Postoperative Complications

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    L. reuteri

    Placebo

    Arm Description

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

    Placebo lozenges three times daily for 2 weeks

    Outcomes

    Primary Outcome Measures

    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)
    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)
    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)
    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)
    Frequency of Painkillers Intake after Surgery
    Frequency expressed in number of painkillers taken per day
    Frequency of Antibiotics Intake after Surgery
    Frequency expressed in number of antibiotics taken per day

    Secondary Outcome Measures

    Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)
    Healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing) assessed by the maxillofacial surgeon
    Levels of salivary oxcytocin
    Microbial counts

    Full Information

    First Posted
    September 14, 2015
    Last Updated
    July 4, 2017
    Sponsor
    University of Copenhagen
    Collaborators
    Halmstad County Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02572531
    Brief Title
    Effect of Probiotics on Pain and Oral Wound Healing After Third Molar Surgery
    Acronym
    PROVIS
    Official Title
    Effect of Probiotic Supplements on Pain and Oral Wound Healing After Third Molar Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    September 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Copenhagen
    Collaborators
    Halmstad County Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Healthy volunteers are consecutively randomized to the test or placebo group. After a standardized surgical procedure, conducted under local anesthesia, the participants are instructed to take three lozenges daily (one in the morning, one at lunch time and one in the evening) containing either two strains of L. reuteri (DSM 17938 and ATCC PTA 5289; >108 CFU per lozenge) or placebo for 2 weeks. The subjects are instructed to let the tablet slowly melt in the oral cavity and to fill in a personal log-book on a daily basis throughout the postoperative period. The patients are recalled to the clinic for follow-up after 1, 2 and 3 weeks for examination. The post-surgical events (pain, swelling, discomfort, feeding problems) are registered daily by the patient in a custom-made logbook. Furthermore, the type and frequency of painkillers and antibiotic prescriptions are noted in the logbook. At the follow-ups, the healing of the wounds/lesions is scored with a clinical healing index. Stimulated saliva samples are collected at baseline and after 2 weeks and kept frozen until further analysis. In addition, smear samples are collected after 1 and 2 weeks from the extraction socket for bacterial analysis. Any subjectively perceived side- or adverse effect in connection with the intervention should be reported to the surgeon. The participants are encouraged to maintain their normal tooth brushing habits.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Complications
    Keywords
    Lactobacillus reuteri, Wound Healing, Third Molar, Postoperative Complications

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    L. reuteri
    Arm Type
    Active Comparator
    Arm Description
    L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo lozenges three times daily for 2 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    L. reuteri DSM 17938/ATCC PTA
    Intervention Description
    Ingestion of active lozenge three times daily for 2 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Ingestion of placebo lozenge three times daily for 2 weeks
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Pain with VAS scale (0-10)
    Description
    VAS scale of the patient's perception of pain (0- I don´t feel any pain, 10- unbearable pain)
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Title
    Change from Baseline in Swelling with VAS scale (0-10)
    Description
    VAS scale of the patient's perception of swelling (0- not swollen at all, 10- extremely swolen, can hardly swallow)
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Title
    Change from Baseline in Feeding Problems with VAS scale (0-10)
    Description
    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)
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Title
    Change from Baseline in Discomfort with VAS scale (0-10)
    Description
    VAS scale of the patient's perception of discomfort (0- No discomfort at all, 10- high discomfort-can not perform daily activities)
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Title
    Frequency of Painkillers Intake after Surgery
    Description
    Frequency expressed in number of painkillers taken per day
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Title
    Frequency of Antibiotics Intake after Surgery
    Description
    Frequency expressed in number of antibiotics taken per day
    Time Frame
    Three weeks: Baseline and 3 follow ups
    Secondary Outcome Measure Information:
    Title
    Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)
    Description
    Healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing) assessed by the maxillofacial surgeon
    Time Frame
    Three weeks: 3 follow-ups
    Title
    Levels of salivary oxcytocin
    Time Frame
    Two weeks: Baseline and two weeks after surgery
    Title
    Microbial counts
    Time Frame
    Two weeks: First and Second Follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Uncompromised general health Non-smoker No systemic medications (except contraceptives) No recent/ongoing episode of antibiotic treatment. Exclusion Criteria: Any pathological condition associated with the third molars detected on radiographs prior to surgery Regular consumers of probiotics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Svante Twetman, Professor
    Organizational Affiliation
    University of Copenhagen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24205344
    Citation
    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.
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    Effect of Probiotics on Pain and Oral Wound Healing After Third Molar Surgery

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