Apical PeriodontitisNCT06574152
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
A study testing PBM treatment and EMS in people with Apical Periodontitis and Endodontically Treated Teeth, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apical Periodontitis, Endodontically Treated Teeth, Endodontic Disease
- What is being tested?
- PBM treatment and EMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2024to 4 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I or II.
- At least one tooth will receive EMS.
- Flap design that includes at least one VRI (triangular, rectangular, papilla base or submarginal rectangular).
Who cannot join
- ASA III or IV.
- Current heavy smokers (>10 cigarettes/day)
- Uncontrolled diabetes (HbA1c ≥ 7%) or other uncontrolled systemic diseases that may comprise healing, such as vitamin C deficiency, neutrophil deficiencies, immunodeficiency syndromes, or leukemia.
- Surgical access on the palatal surface.
- Acute swelling or abscess present on the day of the surgery.
- Any event or condition that would make continued participation in the study not in the best interest of the subject, as determined by the investigator.
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- Pregnancy.
- Development of any medical condition that might affect the treatment and clinical outcomes, as determined by the investigator.
- Initiation of any treatment or exposure that might affect therapy's healing, as determined by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Tanaka, DDS contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Juliana Barros, DDS, MS, 713-486-4564, Juliana.Barros@uth.tmc.edu
Jennifer Tanaka, DDS, Jennifer.A.Tanaka@uth.tmc.edu
About this study
Official title: Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery: A Randomized Clinical Trial
The purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision (VRI) after PBM
Read the detailed description
From the University of Texas Health Science Center School of Dentistry at Houston (UTHealth), forty patients needing endodontic microsurgery (EMS) (where the tissue flap design includes vertical releasing incisions) will be recruited for this study.
Photobiomodulation (PBM) has been used for decades in medicine and dentistry showing promising results in the healing capabilities, however, an accepted protocol has still not been created for its regular use in endodontics. PBM functions on the principle of harnessing light energy to stimulate cellular activity, particularly with the mitochondria (Karu, 2008). When specific wavelengths of light, typically in the red or near-infrared spectrum, penetrate the tissue, a series of photochemical reactions occur. This light energy enhances the production of adenosine triphosphate (ATP), the primary source of cellular energy, leading to improved cellular function and metabolism. Additionally, photobiomodulation can influence various cellular processes, such as reducing oxidative stress and inflammation, ultimately promoting less postoperative pain and enhanced soft tissue healing (Sobouti et al., 2015, Fulop et al., 2010, Sanz-Moliner et al., 2013).
Findings regarding the quality of life after apical surgery suggest that patients commonly hold negative beliefs and perceive it as one of the most painful among endodontic procedures (Morse et al., 1990), when in fact, it could be less unpleasant than expected (Iqbal et al., 2007). Apical surgery has significantly evolved with the introduction of the surgical operating microscope and microsurgical instruments, transforming it into a distinct and more successful procedure. The adoption of microsurgical techniques has been associated with reduced postoperative pain (Pecora et al., 1993), likely due to minimized tissue trauma and enhanced precision facilitated by superior visualization.
Consequently, since PBM can promote pain relief, tissue repair, and regeneration, it may serve as a valuable tool for EMS, reducing postoperative pain and improving overall healing (Mizutani et al., 2016).
Forty adult patients will be invited to participate in this study. They will be divided into two groups: (A) Experimental group (n=20) where patients will receive conventional EMS and PBM treatment, and (B) Control group (n=20) where patients will receive conventional EMS and PBM sham treatment. Preoperative and postoperative pain will be assessed using a visual analog pain scale and the tissue healing will be evaluated by visual inspection and photographs.
- Conditions
- Apical Periodontitis, Endodontically Treated Teeth, Endodontic Disease, Apical Cyst, Apical Granuloma, Periradicular Disease
- Being tested
- PBM treatment, PBM sham treatment, EMS
- Keywords
- vertical incision, photobiomodulation, apicoectomy, endodontic microsurgery, laser therapy
- Medical subject headings
- Periapical Periodontitis, Tooth, Nonvital, Dental Pulp Diseases, Radicular Cyst, Periapical Granuloma, Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBM treatmentDevice
Immediately after the apical microsurgery, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA), with an 8 mm tip diameter . The laser tip will be placed following the outline of the incision flap in a contact mode . The power output of the laser will be 50 milliwatt (mW) and verified by a Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2
PBM sham treatmentDevice
Immediately after the apical microsurgery, sham therapy will be performed without activating the laser.
EMSDevice
Patients will be anesthetized. All surgeries will be performed using a surgical microscope. After reflection of a mucoperiosteal flap, osteotomies will be performed to access the root apices and apical lesions. Root apices will be resected at 3 mm, and the pathological tissue curetted out. Next, root-end preparations will be made with ultrasonic tips and filled with calcium silicate-based materials. Methylene blue dye will be used for inspection after root-end resection before the root-end preparation and filling. After cleaning the osseous crypt, the wound margins will be reapproximated with 5-0 single interrupted sutures. A gauze will be placed for 30 minutes for wound compression. Sutures will be removed seven days postoperatively
| Study group | Role | What they receive |
|---|---|---|
| EMS and PBM treatment 25s group | Experimental | Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J/cm2 (irradiation mode). Receives: Device: PBM treatment; Device: EMS |
| EMS and PBM sham treatment | Sham comparator | The laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation). Receives: Device: PBM sham treatment; Device: EMS |
| EMS and PBM treatment 100s group | Experimental | Photobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 100 seconds with an energy density of 10 J/cm2 (irradiation mode). Receives: Device: PBM treatment; Device: EMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain as assessed by a Visual Analogue Scale (VAS)
this is scored on a likert scale from 0(no pain), 1-3(mild pain), 4-6( moderate pain to 10(worst pain)
Measured: preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).
Secondary outcomes (1)
Change in healing as assessed by the Early Wound Healing Score (EHS).
The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI).
Zero (visible distance between incision margins), 3 (incision margins in contact), or 6(merged incision margins) points were used to evaluate CSR, whereas 0 (bleeding at the incision margins), 1 (presence of fibrin at the incision margins), or 2(absence of fibrin on the incision margins) points were used for CSH and 0 points (redness involving >50% of the incision length and/or pronounced swelling) 1 point (redness involving <50% of the incision length) 2 points (absence of redness along the incision length) were used to analyze CSI
The summation of the points of these 3 parameters generated the EHS. The EHS for ideal wound healing was 10 points, while the worst possible score was 0 points
Measured: preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start20 Aug 2024
- Primary completion4 May 2028 (estimated)
- Study completion4 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Barros, DDS, MS, The University of Texas Health Science Center, Houston
- Investigators
- Juliana Barros, DDS,MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574152
- Sponsor's protocol ID
- HSC-DB-24-0527
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06574152
- Acronym / sponsor ID
- HSC-DB-24-0527
- Conditions
- Apical Periodontitis, Endodontically Treated Teeth, Endodontic Disease, Apical Cyst, Apical Granuloma, Periradicular Disease
- Keywords
- vertical incision, photobiomodulation, apicoectomy, endodontic microsurgery, laser therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 4 May 2028 (estimated)
- Study completion
- 4 May 2028 (estimated)
- First posted
- 27 Aug 2024 (actual)
- 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 purpose of this study is to evaluate the effect of Photobiomodulation (PBM) in postoperative pain after endodontic microsurgery (EMS) in patients from the University of Texas Health Science Center at Houston, School of Dentistry Graduate Endodontic Clinic and to assess the soft tissue healing of the vertical releasing incision (VRI) after PBM
Detailed description
From the University of Texas Health Science Center School of Dentistry at Houston (UTHealth), forty patients needing endodontic microsurgery (EMS) (where the tissue flap design includes vertical releasing incisions) will be recruited for this study.
Photobiomodulation (PBM) has been used for decades in medicine and dentistry showing promising results in the healing capabilities, however, an accepted protocol has still not been created for its regular use in endodontics. PBM functions on the principle of harnessing light energy to stimulate cellular activity, particularly with the mitochondria (Karu, 2008). When specific wavelengths of light, typically in the red or near-infrared spectrum, penetrate the tissue, a series of photochemical reactions occur. This light energy enhances the production of adenosine triphosphate (ATP), the primary source of cellular energy, leading to improved cellular function and metabolism. Additionally, photobiomodulation can influence various cellular processes, such as reducing oxidative stress and inflammation, ultimately promoting less postoperative pain and enhanced soft tissue healing (Sobouti et al., 2015, Fulop et al., 2010, Sanz-Moliner et al., 2013).
Findings regarding the quality of life after apical surgery suggest that patients commonly hold negative beliefs and perceive it as one of the most painful among endodontic procedures (Morse et al., 1990), when in fact, it could be less unpleasant than expected (Iqbal et al., 2007). Apical surgery has significantly evolved with the introduction of the surgical operating microscope and microsurgical instruments, transforming it into a distinct and more successful procedure. The adoption of microsurgical techniques has been associated with reduced postoperative pain (Pecora et al., 1993), likely due to minimized tissue trauma and enhanced precision facilitated by superior visualization.
Consequently, since PBM can promote pain relief, tissue repair, and regeneration, it may serve as a valuable tool for EMS, reducing postoperative pain and improving overall healing (Mizutani et al., 2016).
Forty adult patients will be invited to participate in this study. They will be divided into two groups: (A) Experimental group (n=20) where patients will receive conventional EMS and PBM treatment, and (B) Control group (n=20) where patients will receive conventional EMS and PBM sham treatment. Preoperative and postoperative pain will be assessed using a visual analog pain scale and the tissue healing will be evaluated by visual inspection and photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMS and PBM treatment 25s group | Experimental | Device: PBM treatment, Device: EMSPhotobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 25 seconds with an energy density of 10 J/cm2 (irradiation mode). |
| EMS and PBM sham treatment | Sham comparator | Device: PBM sham treatment, Device: EMSThe laser tip will be placed following the outline of the incision flap in a contact mode but without activating it (no irradiation). |
| EMS and PBM treatment 100s group | Experimental | Device: PBM treatment, Device: EMSPhotobiomodulation (PBM) therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA) following the outline of the incision flap in a contact mode. Each site will be irradiated for 100 seconds with an energy density of 10 J/cm2 (irradiation mode). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) I or II.
- At least one tooth will receive EMS.
- Flap design that includes at least one VRI (triangular, rectangular, papilla base or submarginal rectangular).
Key exclusion criteria (9 listed)
- ASA III or IV.
- Current heavy smokers (>10 cigarettes/day)
- Uncontrolled diabetes (HbA1c ≥ 7%) or other uncontrolled systemic diseases that may comprise healing, such as vitamin C deficiency, neutrophil deficiencies, immunodeficiency syndromes, or leukemia.
- Surgical access on the palatal surface.
- Acute swelling or abscess present on the day of the surgery.
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 |
|---|---|---|
| PBM treatmentImmediately after the apical microsurgery, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, North Carolina, USA), with an 8 mm tip diameter . The laser tip will be placed following the outline of the incision flap in a contact mode . The power output of the laser will be 50 milliwatt (mW) and verified by a Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 | Device | EMS and PBM treatment 100s group, EMS and PBM treatment 25s group |
| PBM sham treatmentImmediately after the apical microsurgery, sham therapy will be performed without activating the laser. | Device | EMS and PBM sham treatment |
| EMSPatients will be anesthetized. All surgeries will be performed using a surgical microscope. After reflection of a mucoperiosteal flap, osteotomies will be performed to access the root apices and apical lesions. Root apices will be resected at 3 mm, and the pathological tissue curetted out. Next, root-end preparations will be made with ultrasonic tips and filled with calcium silicate-based materials. Methylene blue dye will be used for inspection after root-end resection before the root-end preparation and filling. After cleaning the osseous crypt, the wound margins will be reapproximated with 5-0 single interrupted sutures. A gauze will be placed for 30 minutes for wound compression. Sutures will be removed seven days postoperatively | Device | EMS and PBM sham treatment, EMS and PBM treatment 100s group, EMS and PBM treatment 25s group |
Primary outcome
Change in pain as assessed by a Visual Analogue Scale (VAS)
Time frame: preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).
this is scored on a likert scale from 0(no pain), 1-3(mild pain), 4-6( moderate pain to 10(worst pain)
1 secondary outcome
Change in healing as assessed by the Early Wound Healing Score (EHS).
Time frame: preoperative assessment (baseline), immediately after surgery, and 5-7 days post-surgery during the sutures removal appointment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jennifer Tanaka, DDS contact
Juliana Barros, DDS,MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PBM treatment and EMS in people with Apical Periodontitis and Endodontically Treated Teeth, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana Barros, DDS,MS ((713) 486-4564, Juliana.Barros@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as assessed by a Visual Analogue Scale (VAS) (time frame: preoperative assessment (baseline), in the day of the intervention (surgery day) and 5-7 days after the surgery (sutures removal appointment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.