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

Not Applicable

• Conditions: Postoperative Complications
• Interventions: Dietary Supplement: L. reuteri DSM 17938/ATCC PTA; Dietary Supplement: Placebo

• Registration Number: NCT02572531
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-09
• Study Start: 2016-09-01
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-04
• Last Update Posted: 2017-07-06
• Primary Completion: 2018-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L. reuteri	L. reuteri DSM 17938/ATCC PTA	L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks
Placebo	Placebo	Placebo lozenges three times daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Pain with VAS scale (0-10)	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)
Change from Baseline in Swelling with VAS scale (0-10)	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)	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)	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	Three weeks: Baseline and 3 follow ups	Frequency expressed in number of painkillers taken per day
Frequency of Antibiotics Intake after Surgery	Three weeks: Baseline and 3 follow ups	Frequency expressed in number of antibiotics taken per day

Secondary Outcome Measures

Name	Time	Method
Clinical healing index by Landry et al. Scale from 1-5 (1 very poor healing - 5 very good healing)	Three weeks: 3 follow-ups	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	Two weeks: Baseline and two weeks after surgery
Microbial counts	Two weeks: First and Second Follow-up