Postoperative ComplicationsPROVISNCT02572531
Effect of Probiotics on Pain and Oral Wound Healing After Third Molar Surgery
A study testing L. reuteri DSM 17938/ATCC PTA in people with Postoperative Complications, run by University of Copenhagen.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- L. reuteri DSM 17938/ATCC PTA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Uncompromised general health
- Non-smoker
- No systemic medications (except contraceptives)
- No recent/ongoing episode of antibiotic treatment.
Who cannot join
- Any pathological condition associated with the third molars detected on radiographs prior to surgery
- Regular consumers of probiotics
About this study
Official title: 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.
Read the 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
- Being tested
- L. reuteri DSM 17938/ATCC PTA, Placebo
- Keywords
- Lactobacillus reuteri, Wound Healing, Third Molar, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938/ATCC PTADietary supplement
Ingestion of active lozenge three times daily for 2 weeks
PlaceboDietary supplement
Ingestion of placebo lozenge three times daily for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Active comparator | L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks Receives: Dietary Supplement: L. reuteri DSM 17938/ATCC PTA |
| Placebo | Placebo comparator | Placebo lozenges three times daily for 2 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Three weeks: Baseline and 3 follow ups
Frequency of Painkillers Intake after Surgery
Frequency expressed in number of painkillers taken per day
Measured: Three weeks: Baseline and 3 follow ups
Frequency of Antibiotics Intake after Surgery
Frequency expressed in number of antibiotics taken per day
Measured: Three weeks: Baseline and 3 follow ups
Secondary outcomes (3)
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
Measured: Three weeks: 3 follow-ups
Levels of salivary oxcytocin
Measured: Two weeks: Baseline and two weeks after surgery
Microbial counts
Measured: Two weeks: First and Second Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study start1 Sep 2016
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Halmstad County Hospital
- Responsible party
- Principal investigator, Gina Castiblanco, University of Copenhagen
- Investigators
- Svante Twetman, Professor, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572531
- Sponsor's protocol ID
- 2015-483
- Acronym
- PROVIS
- Status last verified
- Jul 2017
- First submitted
- 14 Sep 2015
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24205344
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplements on Pain and Oral Wound Healing After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT02572531
- Acronym / sponsor ID
- PROVIS / 2015-483
- Conditions
- Postoperative Complications
- Keywords
- Lactobacillus reuteri, Wound Healing, Third Molar, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Halmstad County Hospital
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Active comparator | Dietary Supplement: L. reuteri DSM 17938/ATCC PTAL. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 2 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo lozenges three times daily for 2 weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Uncompromised general health
- Non-smoker
- No systemic medications (except contraceptives)
- No recent/ongoing episode of antibiotic treatment.
Key exclusion criteria (2 listed)
- Any pathological condition associated with the third molars detected on radiographs prior to surgery
- Regular consumers of probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L. reuteri DSM 17938/ATCC PTAIngestion of active lozenge three times daily for 2 weeks | Dietary supplement | L. reuteri |
| PlaceboIngestion of placebo lozenge three times daily for 2 weeks | Dietary supplement | Placebo |
Primary outcome
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)
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)
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)
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)
Frequency of Painkillers Intake after Surgery
Time frame: Three weeks: Baseline and 3 follow ups
Frequency expressed in number of painkillers taken per day
Frequency of Antibiotics Intake after Surgery
Time frame: Three weeks: Baseline and 3 follow ups
Frequency expressed in number of antibiotics taken per day
3 secondary outcomes
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
Levels of salivary oxcytocin
Time frame: Two weeks: Baseline and two weeks after surgery
Microbial counts
Time frame: Two weeks: First and Second Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2017.
- Background: PubMed 24205344Poutahidis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svante Twetman, Professor study director
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri DSM 17938/ATCC PTA in people with Postoperative Complications, run by University of Copenhagen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Pain with VAS scale (0-10) (time frame: Three weeks: Baseline and 3 follow ups). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017.