Impact of Nd:YAG Laser Photobiostimulation on Healing of Gingiva

NCT ID: NCT07095556

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2027-04-30

Brief Summary

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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

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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

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Wound Healing and Prevention Oral Inflammation Photobiomodulation Post-operative Pain Management Tooth Extraction Site Healing

Keywords

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Inflammation Periodontal Disease low-level laser therapy gingival healing Post-operative pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

Sham laser will be applied instead of the low-level laser.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

Low-level lase therapy will be applied at tooth extraction sites.

Group Type EXPERIMENTAL

Low-level laser therapy

Intervention Type OTHER

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.

Interventions

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Low-level laser therapy

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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"

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pinar Emecen-Huja

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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MUSC College of Dental Medicine, Graduate Periodontics Clinic

Charleston, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pinar Emecen-Huja

Role: CONTACT

Phone: (843) 792-5688

Email: [email protected]

Facility Contacts

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Joe Gambacorta, DDS

Role: primary

Ben (Hua-Hong) Chien, DDS

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 27088277 (View on PubMed)

Cafiero 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.

Reference Type BACKGROUND
PMID: 33916672 (View on PubMed)

Saglam 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.

Reference Type BACKGROUND
PMID: 28332191 (View on PubMed)

Fulop 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.

Reference Type BACKGROUND
PMID: 20842007 (View on PubMed)

Mizutani 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.

Reference Type BACKGROUND
PMID: 27045437 (View on PubMed)

Krizaj 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.

Reference Type BACKGROUND
PMID: 33686771 (View on PubMed)

Other Identifiers

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Pro00139090

Identifier Type: -

Identifier Source: org_study_id