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NCT03741062

Effects of Laser Stimulation on Wound Healing of Human Palatal Tissue

Terminated NA Results posted Last updated 10 November 2020
What this trial tests

NA trial testing J. Morita AdvErl Evo Er:YAG laser in Healing Surgical Wounds in 11 participants. Terminated before completion.

Timeline
24 January 2019
Primary endpoint
17 March 2020
14 May 2020

Quick facts

Lead sponsorUniversity of Manitoba
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposesupportive care
Enrollment11
Start date24 January 2019
Primary completion17 March 2020
Estimated completion14 May 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University of Manitoba

Who can join

Eligibility, any sex, with Healing Surgical Wounds or Pain Measurement. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-Reported Patient Discomfort as Assessed by a Visual Analogue Scale Primary · One week

At the end of their surgical appointment, patients will be given a Visual Analogue Scale (VAS) questionnaire to rate their post-operative pain by making a mark along a 10-cm line (0 = no pain, 10 = unbearable pain) for each night of the first post-operative week. At the one-week post-operative appointment, the participants will return their VAS questionnaires and their reported post-operative discomfort for each night of the initial post-operative week will be tabulated.

Day 1
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser4.900.2 – 9.0
Control2.450.0 – 9.3
Day 2
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser3.300.1 – 8.0
Control0.830.0 – 4.3
Day 3
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser2.930.1 – 8.0
Control0.720.0 – 3.5
Day 4
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser2.750.2 – 7.0
Control0.400.0 – 1.5
Day 5
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser2.650.2 – 7.0
Control0.320.0 – 1.2
Day 6
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser2.650.2 – 6.0
Control0.160.0 – 0.5
Patient Discomfort as Assessed by Analgesic Consumption Primary · One week

At the end of their surgical appointment, patients will be provided with a bag of 30 200-mg Ibuprofen tablets. At the one-week post-operative appointment, the participants will return any remaining Ibuprofen tablets and their total analgesic consumption for the initial post-operative week will be tabulated.

GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser10.51.0 – 23.0
Control6.00.0 – 16.0
Self-Reported Patient Discomfort as Assessed by a Oral Impacts on Daily Performance Questionnaire Primary · One Week

At the one-week post-operative appointment, patients will complete a modified Oral Impacts on Daily Performance (OIDP) questionnaire to assess the effect of the palatal wound on their oral-health related quality of life during the first post-operative week. They will rate the overall frequency of disruptions that the palatal surgical site had on eating, speaking, oral hygiene, light physical work, participation in regular outings, sleeping, relaxing, smiling and laughing, their mood, and interpersonal interactions by making a mark along a 10-cm line (0 = never, 10 = constantly) for first post-

Frequency of Disruptions to Eating Food
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser7.523.0 – 9.6
Control3.650.0 – 9.5
Severity of Disruptions to Eating Food
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser5.250.1 – 8.2
Control2.650.1 – 5.3
Frequency of Disruptions to Speaking
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser4.730.9 – 7.3
Control1.870.0 – 9.2
Severity of Disruptions to Speaking
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser3.280.1 – 7.4
Control0.550.0 – 1.5
Frequency of Disruptions when Performing Oral Hygiene
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser5.181.0 – 9.1
Control4.220.0 – 9.7
Severity of Disruptions when Performing Oral Hygiene
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser4.400.1 – 8.8
Control4.980.2 – 9.7
Frequency of Disruptions when Performing Light Work
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser1.300.6 – 2.0
Control0.250.0 – 1.0
Severity of Disruptions when Performing Light Work
GroupValue95% CI
J. Morita AdvErl Evo Er:YAG Laser0.900.1 – 1.9
Control0.350.0 – 1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for the 6-week period during which the study was conducted for each patient.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

J. Morita AdvErl Evo Er:YAG Laser
Serious: 0/5 (0%)
Deaths: 0/5
Control
Serious: 0/6 (0%)
Deaths: 0/6
Other adverse events (2 terms — click to expand)

ReactionSystemJ. Morita AdvErl Evo Er:YA…Control
Inadequate Hemostasis at Donor SiteInjury, poisoning and procedural complications
HematomaInjury, poisoning and procedural complications

Data from ClinicalTrials.gov NCT03741062 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effects of photobiomodulation (PBM) with an Er:YAG laser on the palatal donor site following subepithelial connective tissue graft (SECTG) surgery. Patient-centred outcomes and wound healing will be compared between a control group, who receives no laser treatment, and the test group receiving PBM therapy. It is hypothesized that laser stimulation will have a beneficial effect on the patient's post-operative experience as well as the healing of the tissues.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Photobiomodulation in 3D tissue engineering.
    Bikmulina P, Kosheleva N, Shpichka A, Yusupov V, et al · · 2022 · cited 13× · PMID 36104833 · DOI 10.1117/1.jbo.27.9.090901

Verify or expand the search:

Other recruiting trials for Healing Surgical Wounds

Currently open trials in the same condition.

Other University of Manitoba trials

Trials by the same sponsor.

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