Wound Healing and PreventionNCT07095556
Impact of Nd:YAG Laser Photobiostimulation on Healing of Gingiva
A study testing Low-level laser therapy in people with Wound Healing and Prevention and Oral Inflammation, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The intervention in this study is to determine whether multiple applications of photobiostimulation with Nd-YAG laser improve wound healing following tooth extraction and alveolar ridge preservation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound Healing and Prevention, Oral Inflammation, Photobiomodulation
- What is being tested?
- Low-level laser therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2025to 30 Apr 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who are ≥ 18 years old,
- Patients who are scheduled for the treatment of tooth extraction and alveolar ridge preservation (ARP)
- No contraindications for tooth extraction and alveolar ridge preservation based on electronic health records.
- Participants who can express the level of pain
- Participants who self-report "not pregnant"
Who cannot join
- Untreated periodontal disease
- Acute infection of the teeth
- Use of antibiotics within the last three months.
- Pregnant or lactating women
- Use of bisphosphonates based on EHR
- Alveolar bone defects occurred or were detected during tooth extraction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MUSC College of Dental Medicine, Graduate Periodontics Clinic
Charleston, South Carolina, 29425
Joe Gambacorta, DDS, 843-876-7645, gambacor@musc.edu
Ben (Hua-Hong) Chien, DDS, chienh@musc.edu
About this study
Official title: Impact of Nd: YAG Laser Photobiostimulation on Healing of Gingiva Following Tooth Extraction and Alveolar Ridge Preservation
The intervention in this study is to determine whether multiple applications of photobiostimulation with Nd-YAG laser improve wound healing following tooth extraction and alveolar ridge preservation. Investigators plan to assess the impact of laser treatment on wound healing by measuring salivary biomarkers, gingival wound size and surveying for the use of pain reduction and patient satisfaction. The intervention group will receive extraction and alveolar ridge preservation with Nd-YAG laser photobiostimulation on days 1, 3, and 7 following extraction and socket preservation, while the control group will receive the standard of care extraction and alveolar ridge preservation without the laser
Read the detailed description
Photobiostimulation, also known as low-level laser therapy (LLLT) or phototherapy, utilizes a low-level laser to increase cell proliferation, enhance cell stimulation, and reduce gingival inflammation. It has been reported that photobiostimulation enhances chemical and metabolic changes and alters cellular behavior in the tissue by light absorption. Photobiostimulation as an adjunct treatment modality can accelerate the healing process, improve patient comfort and satisfaction following dental surgical procedures, and benefit patients with compromised healing capacity.
Alveolar ridge preservation (ARP) is a standard procedure to minimize alveolar bone and gingival soft tissue atrophy following tooth extraction and before dental implant placement. The healing of ARP is critical for the success of implant placement timely treatment. The ARP procedure is currently the standard practice for patients interested in dental implant treatment and involves bone grafting of the extracted socket. ARP techniques have been used for over 20 years to maintain a favorable soft and hard tissue morphology for dental implant-related restorations.
The purpose of this study is to understand the impact of Nd-YAG laser photobiostimulation on wound healing when combined with tooth extraction and alveolar ridge preservation procedures.
- Conditions
- Wound Healing and Prevention, Oral Inflammation, Photobiomodulation, Post-operative Pain Management, Tooth Extraction Site Healing
- Being tested
- Low-level laser therapy
- Keywords
- Inflammation, Periodontal Disease, low-level laser therapy, gingival healing, Post-operative pain
- Medical subject headings
- Inflammation, Periodontal Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-level laser therapyOther
The low-level laser applications will be made on the same day as the standard of care treatment (day 1), and then day 3, and day 7 by a study team member who is trained in the use of the laser device.
The laser photobiostimulation will be applied using LightWalker® laser (FOTONA), with following settings, Nd:YAG laser 1064 nm, MSP modality (pulse duration), 0.5 W (power), 10 Hz (frequency), 1 min/ 1 cm2 spot using Genova handpiece from buccal, lingual, and occlusal aspects. The Genova handpiece will be placed 1 cm away from gingival tissue.
Participants and operators will wear glasses to protect their eyes from laser beam in all sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Sham laser will be applied instead of the low-level laser. |
| Intervention | Experimental | Low-level lase therapy will be applied at tooth extraction sites. Receives: Other: Low-level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers in saliva
The measurement of inflammatory and anti-inflammatory markers in saliva, IL-1β, IL-6, IL-8, IL-10, IL-12 and TNF secreted during the early stages of wound healing at day 3 and day 7.
Measured: From day of tooth extraction through day 7
Wound size dimensional changes
The comparison of dimensional changes in wound size between test and intervention groups. Digital gingival scans of the wound will be taken immediately after surgery and at days 3, 7, 14, and 42 for Aim 2.
Measured: From the day of tooth extraction to day 42
Post-operative pain
Recording of pain perception using a Visual Analog Scale at visits 3, 7, and 14 (maximum pain being 10 vs. no pain being 0), 2)
Measured: From post-operative day 3 to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start5 Nov 2025
- Primary completionDec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Wound Healing and PreventionStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinar Emecen-Huja, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095556
- Sponsor's protocol ID
- Pro00139090
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-beta1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clinical Study. Photomed Laser Surg. 2016 Jun;34(6):263-71. doi: 10.1089/pho.2016.4094. Epub 2016 Apr 18.
PubMed 27088277Cafiero C, Spagnuolo G, Marenzi G, Martuscelli R, Colamaio M, Leuci S. Predictive Periodontitis: The Most Promising Salivary Biomarkers for Early Diagnosis of Periodontitis. J Clin Med. 2021 Apr 3;10(7):1488. doi: 10.3390/jcm10071488.
PubMed 33916672Saglam M, Koseoglu S, Tasdemir I, Erbak Yilmaz H, Savran L, Sutcu R. Combined application of Er:YAG and Nd:YAG lasers in treatment of chronic periodontitis. A split-mouth, single-blind, randomized controlled trial. J Periodontal Res. 2017 Oct;52(5):853-862. doi: 10.1111/jre.12454. Epub 2017 Mar 23.
PubMed 28332191Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of laser phototherapy on pain relief. Clin J Pain. 2010 Oct;26(8):729-36. doi: 10.1097/AJP.0b013e3181f09713.
PubMed 20842007Mizutani K, Aoki A, Coluzzi D, Yukna R, Wang CY, Pavlic V, Izumi Y. Lasers in minimally invasive periodontal and peri-implant therapy. Periodontol 2000. 2016 Jun;71(1):185-212. doi: 10.1111/prd.12123.
PubMed 27045437Krizaj Dumic A, Pajk F, Olivi G. The effect of post-extraction socket preservation laser treatment on bone density 4 months after extraction: Randomized controlled trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):309-316. doi: 10.1111/cid.12991. Epub 2021 Mar 8.
PubMed 33686771
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nd: YAG Laser Photobiostimulation on Healing of Gingiva Following Tooth Extraction and Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT07095556
- Acronym / sponsor ID
- Pro00139090
- Conditions
- Wound Healing and Prevention, Oral Inflammation, Photobiomodulation, Post-operative Pain Management, Tooth Extraction Site Healing
- Keywords
- Inflammation, Periodontal Disease, low-level laser therapy, gingival healing, Post-operative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 31 Jul 2025 (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 intervention in this study is to determine whether multiple applications of photobiostimulation with Nd-YAG laser improve wound healing following tooth extraction and alveolar ridge preservation. Investigators plan to assess the impact of laser treatment on wound healing by measuring salivary biomarkers, gingival wound size and surveying for the use of pain reduction and patient satisfaction. The intervention group will receive extraction and alveolar ridge preservation with Nd-YAG laser photobiostimulation on days 1, 3, and 7 following extraction and socket preservation, while the control group will receive the standard of care extraction and alveolar ridge preservation without the laser
Detailed description
Photobiostimulation, also known as low-level laser therapy (LLLT) or phototherapy, utilizes a low-level laser to increase cell proliferation, enhance cell stimulation, and reduce gingival inflammation. It has been reported that photobiostimulation enhances chemical and metabolic changes and alters cellular behavior in the tissue by light absorption. Photobiostimulation as an adjunct treatment modality can accelerate the healing process, improve patient comfort and satisfaction following dental surgical procedures, and benefit patients with compromised healing capacity.
Alveolar ridge preservation (ARP) is a standard procedure to minimize alveolar bone and gingival soft tissue atrophy following tooth extraction and before dental implant placement. The healing of ARP is critical for the success of implant placement timely treatment. The ARP procedure is currently the standard practice for patients interested in dental implant treatment and involves bone grafting of the extracted socket. ARP techniques have been used for over 20 years to maintain a favorable soft and hard tissue morphology for dental implant-related restorations.
The purpose of this study is to understand the impact of Nd-YAG laser photobiostimulation on wound healing when combined with tooth extraction and alveolar ridge preservation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Sham laser will be applied instead of the low-level laser. |
| Intervention | Experimental | Other: Low-level laser therapyLow-level lase therapy will be applied at tooth extraction sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who are ≥ 18 years old,
- Patients who are scheduled for the treatment of tooth extraction and alveolar ridge preservation (ARP)
- No contraindications for tooth extraction and alveolar ridge preservation based on electronic health records.
- Participants who can express the level of pain
- Participants who self-report "not pregnant"
Key exclusion criteria (6 listed)
- Untreated periodontal disease
- Acute infection of the teeth
- Use of antibiotics within the last three months.
- Pregnant or lactating women
- Use of bisphosphonates based on EHR
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 |
|---|---|---|
| Low-level laser therapyThe low-level laser applications will be made on the same day as the standard of care treatment (day 1), and then day 3, and day 7 by a study team member who is trained in the use of the laser device. The laser photobiostimulation will be applied using LightWalker® laser (FOTONA), with following settings, Nd:YAG laser 1064 nm, MSP modality (pulse duration), 0.5 W (power), 10 Hz (frequency), 1 min/ 1 cm2 spot using Genova handpiece from buccal, lingual, and occlusal aspects. The Genova handpiece will be placed 1 cm away from gingival tissue. Participants and operators will wear glasses to protect their eyes from laser beam in all sessions. | Other | Intervention |
Primary outcome
Inflammatory markers in saliva
Time frame: From day of tooth extraction through day 7
The measurement of inflammatory and anti-inflammatory markers in saliva, IL-1β, IL-6, IL-8, IL-10, IL-12 and TNF secreted during the early stages of wound healing at day 3 and day 7.
Wound size dimensional changes
Time frame: From the day of tooth extraction to day 42
The comparison of dimensional changes in wound size between test and intervention groups. Digital gingival scans of the wound will be taken immediately after surgery and at days 3, 7, 14, and 42 for Aim 2.
Post-operative pain
Time frame: From post-operative day 3 to day 14
Recording of pain perception using a Visual Analog Scale at visits 3, 7, and 14 (maximum pain being 10 vs. no pain being 0), 2)
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 12 Nov 2025.
- Background: PubMed 27088277Keskiner I, Lutfioglu M, Aydogdu A, Saygun NI, Serdar MA. Effect of Photobiomodulation on Transforming Growth Factor-beta1, Platelet-Derived Growth Factor-BB, and Interleukin-8 Release in Palatal Wounds After Free Gingival Graft Harvesting: A Randomized Clinical Study. Photomed Laser Surg. 2016 Jun;34(6):263-71. doi: 10.1089/pho.2016.4094. Epub 2016 Apr 18.
- Background: PubMed 33916672Cafiero C, Spagnuolo G, Marenzi G, Martuscelli R, Colamaio M, Leuci S. Predictive Periodontitis: The Most Promising Salivary Biomarkers for Early Diagnosis of Periodontitis. J Clin Med. 2021 Apr 3;10(7):1488. doi: 10.3390/jcm10071488.
- Background: PubMed 28332191Saglam M, Koseoglu S, Tasdemir I, Erbak Yilmaz H, Savran L, Sutcu R. Combined application of Er:YAG and Nd:YAG lasers in treatment of chronic periodontitis. A split-mouth, single-blind, randomized controlled trial. J Periodontal Res. 2017 Oct;52(5):853-862. doi: 10.1111/jre.12454. Epub 2017 Mar 23.
- Background: PubMed 20842007Fulop AM, Dhimmer S, Deluca JR, Johanson DD, Lenz RV, Patel KB, Douris PC, Enwemeka CS. A meta-analysis of the efficacy of laser phototherapy on pain relief. Clin J Pain. 2010 Oct;26(8):729-36. doi: 10.1097/AJP.0b013e3181f09713.
- Background: PubMed 27045437Mizutani K, Aoki A, Coluzzi D, Yukna R, Wang CY, Pavlic V, Izumi Y. Lasers in minimally invasive periodontal and peri-implant therapy. Periodontol 2000. 2016 Jun;71(1):185-212. doi: 10.1111/prd.12123.
- Background: PubMed 33686771Krizaj Dumic A, Pajk F, Olivi G. The effect of post-extraction socket preservation laser treatment on bone density 4 months after extraction: Randomized controlled trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):309-316. doi: 10.1111/cid.12991. Epub 2021 Mar 8.
- 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.
Pinar Emecen-Huja principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-level laser therapy in people with Wound Healing and Prevention and Oral Inflammation, run by Medical University of South Carolina 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 5 inclusion and 6 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 12 Nov 2025. 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. 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 Pinar Emecen-Huja ((843) 792-5688, emecenh@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers in saliva (time frame: From day of tooth extraction through day 7). The study lists 3 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 NCT07095556, which also lists 6 linked publications.
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 12 Nov 2025.