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

NCT ID: NCT02572531

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-12-31

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.

Conditions

Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

L. reuteri

L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks

Group Type: ACTIVE_COMPARATOR

L. reuteri DSM 17938/ATCC PTA

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of active lozenge three times daily for 2 weeks

Placebo

Placebo lozenges three times daily for 2 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of placebo lozenge three times daily for 2 weeks

Interventions

L. reuteri DSM 17938/ATCC PTA

Ingestion of active lozenge three times daily for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Ingestion of placebo lozenge three times daily for 2 weeks

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Halmstad County Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Gina Castiblanco

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Svante Twetman, Professor

Role: STUDY_DIRECTOR

University of Copenhagen

References

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.

Reference Type: BACKGROUND

PMID: 24205344 (View on PubMed)

Other Identifiers

2015-483

Identifier Type: -

Identifier Source: org_study_id