Clinical trial NCT02572531: Effect of Probiotics on Pain and Oral Wound Healing After Third Molar Surgery
Official title: Effect of Probiotic Supplements on Pain and Oral Wound Healing After Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Complications
Keywords: Lactobacillus reuteri
Wound Healing
Third Molar
Postoperative Complications
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Halmstad County Hospital
First posted: 2015-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from Baseline in Pain with VAS scale (0-10)
timeFrame: Three weeks: Baseline and 3 follow ups
measure: Change from Baseline in Swelling with VAS scale (0-10)
timeFrame: Three weeks: Baseline and 3 follow ups
measure: Change from Baseline in Feeding Problems with VAS scale (0-10)
timeFrame: Three weeks: Baseline and 3 follow ups
measure: Change from Baseline in Discomfort with VAS scale (0-10)
timeFrame: Three weeks: Baseline and 3 follow ups
measure: Frequency of Painkillers Intake after Surgery
timeFrame: Three weeks: Baseline and 3 follow ups
measure: Frequency of Antibiotics Intake after Surgery
timeFrame: Three weeks: Baseline and 3 follow ups
Secondary outcomes:
measure: Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)
timeFrame: Three weeks: 3 follow-ups
measure: Levels of salivary oxcytocin
timeFrame: Two weeks: Baseline and two weeks after surgery
measure: Microbial counts
timeFrame: Two weeks: First and Second Follow-up
Other outcomes:
Locations:
Study officials:
affiliation: University of Copenhagen
name: Svante Twetman, Professor
role: STUDY_DIRECTOR
References:
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.