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

July 4, 2017 updated by: Gina Castiblanco, University of Copenhagen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L. reuteri
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
Ingestion of active lozenge three times daily for 2 weeks
Placebo Comparator: Placebo
Placebo lozenges three times daily for 2 weeks
Dietary supplement: Placebo
Ingestion of placebo lozenge three times daily for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Pain with VAS scale (0-10)
Time Frame: 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)
Three weeks: Baseline and 3 follow ups
Change from Baseline in Swelling with VAS scale (0-10)
Time Frame: 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)
Three weeks: Baseline and 3 follow ups
Change from Baseline in Feeding Problems with VAS scale (0-10)
Time Frame: 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)
Three weeks: Baseline and 3 follow ups
Change from Baseline in Discomfort with VAS scale (0-10)
Time Frame: 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)
Three weeks: Baseline and 3 follow ups
Frequency of Painkillers Intake after Surgery
Time Frame: Three weeks: Baseline and 3 follow ups
Frequency expressed in number of painkillers taken per day
Three weeks: Baseline and 3 follow ups
Frequency of Antibiotics Intake after Surgery
Time Frame: Three weeks: Baseline and 3 follow ups
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)
Time Frame: 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
Three weeks: 3 follow-ups
Levels of salivary oxcytocin
Time Frame: Two weeks: Baseline and two weeks after surgery
Two weeks: Baseline and two weeks after surgery
Microbial counts
Time Frame: Two weeks: First and Second Follow-up
Two weeks: First and Second Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Halmstad County Hospital

Investigators

  • Study Director: Svante Twetman, Professor, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 14, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2017

Last Update Submitted That Met QC Criteria

July 4, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-483

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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