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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Ingestion of active lozenge three times daily for 2 weeks
Ingestion of placebo lozenge three times daily for 2 weeks
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Three weeks: Baseline and 3 follow ups
Frequency of Painkillers Intake after Surgery
Frequency expressed in number of painkillers taken per day
Time frame: Three weeks: Baseline and 3 follow ups
Frequency of Antibiotics Intake after Surgery
Frequency expressed in number of antibiotics taken per day
Time frame: Three weeks: Baseline and 3 follow ups
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
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Time frame: Three weeks: 3 follow-ups
Levels of salivary oxcytocin
Time frame: Two weeks: Baseline and two weeks after surgery
Microbial counts
Time frame: Two weeks: First and Second Follow-up