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

Postoperative Complications Clinical Trial

— PROVIS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02572531
• Other study ID #: 2015-483
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 14, 2015
• Last updated: July 4, 2017
• Start date: September 1, 2016
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Dietary Supplement:
• L. reuteri DSM 17938/ATCC PTA
Ingestion of active lozenge three times daily for 2 weeks
• Placebo
Ingestion of placebo lozenge three times daily for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Halmstad County Hospital

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Frequency of Painkillers Intake after Surgery	Frequency expressed in number of painkillers taken per day	Three weeks: Baseline and 3 follow ups
Primary	Frequency of Antibiotics Intake after Surgery	Frequency expressed in number of antibiotics taken per day	Three weeks: Baseline and 3 follow ups
Secondary	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
Secondary	Levels of salivary oxcytocin		Two weeks: Baseline and two weeks after surgery
Secondary	Microbial counts		Two weeks: First and Second Follow-up