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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Complications

Intervention / Treatment
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* Dietary Supplement: L. reuteri DSM 17938/ATCC PTA
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L. reuteri<br>L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks | Dietary Supplement: L. reuteri DSM 17938/ATCC PTA<br>* Ingestion of active lozenge three times daily for 2 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo lozenges three times daily for 2 weeks | Dietary Supplement: Placebo<br>* Ingestion of placebo lozenge three times daily for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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) | 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) | Three weeks: Baseline and 3 follow ups | 
| Frequency of Painkillers Intake after Surgery | Frequency expressed in number of painkillers taken per day | Three weeks: Baseline and 3 follow ups | 
| Frequency of Antibiotics Intake after Surgery | Frequency expressed in number of antibiotics taken per day | Three weeks: Baseline and 3 follow ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus reuteri, Wound Healing, Third Molar, Postoperative Complications