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
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
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
NCT ID
NCT02572531
First Posted
September 14, 2015
Last Updated
July 4, 2017
Sponsor
University of Copenhagen
Collaborators
Halmstad County Hospital
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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