Impact of Nd:YAG Laser Photobiostimulation on Healing of Gingiva

NCT07095556 | Recruiting

• 1 other identifier: Pro00139090
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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. 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

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

  From post-operative day 3 to day 14

Study Arms (2)

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.

Other: Low-level laser therapy

Interventions

Low-level laser therapy 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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

MUSC College of Dental Medicine, Graduate Periodontics Clinic

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 27088277 BACKGROUND

• 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.

  PMID: 33916672 BACKGROUND

• 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.

  PMID: 28332191 BACKGROUND

• 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.

  PMID: 20842007 BACKGROUND

• 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.

  PMID: 27045437 BACKGROUND

• 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.

  PMID: 33686771 BACKGROUND

MeSH Terms

Conditions

Inflammation; Periodontal Diseases; Pain, Postoperative

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mouth Diseases; Stomatognathic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Pinar Emecen-Huja

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinar Emecen-Huja

CONTACT

(843) 792-5688; emecenh@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 31, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)