Skip to main content
Clinical Trials/NCT02572531
NCT02572531UnknownNot Applicable

Effect of Probiotic Supplements on Pain and Oral Wound Healing After Third Molar Surgery

University of Copenhagen0 sites60 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Primary Endpoint
Change from Baseline in Swelling with VAS scale (0-10)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

L. reuteri

Active Comparator

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

Intervention: L. reuteri DSM 17938/ATCC PTA (Dietary Supplement)

Placebo

Placebo Comparator

Placebo lozenges three times daily for 2 weeks

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

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

Time Frame: Three weeks: Baseline and 3 follow ups

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)

Time Frame: Three weeks: Baseline and 3 follow ups

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)

Time Frame: Three weeks: Baseline and 3 follow ups

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

Time Frame: Three weeks: Baseline and 3 follow ups

Frequency expressed in number of painkillers taken per day

Frequency of Antibiotics Intake after Surgery

Time Frame: Three weeks: Baseline and 3 follow ups

Frequency expressed in number of antibiotics taken per day

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

Time Frame: Three weeks: Baseline and 3 follow ups

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gina Castiblanco

Dr.

University of Copenhagen

Similar Trials

Effect of Probiotics on Pain and Oral... | Clinical Trial