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Impact of Nd:YAG Laser Photobiostimulation on Healing of Gingiva

Not Applicable
Not yet recruiting
Conditions
Wound Healing and Prevention
Oral Inflammation
Photobiomodulation
Post-operative Pain Management
Tooth Extraction Site Healing
Registration Number
NCT07095556
Lead Sponsor
Medical University of South Carolina
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

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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
39
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Inflammatory markers in salivaFrom 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 changesFrom 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 painFrom 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)

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

MUSC College of Dental Medicine, Graduate Periodontics Clinic

🇺🇸

Charleston, South Carolina, United States

MUSC College of Dental Medicine, Graduate Periodontics Clinic
🇺🇸Charleston, South Carolina, United States
Joe Gambacorta, DDS
Contact
843-876-7645
gambacor@musc.edu
Ben (Hua-Hong) Chien, DDS
Contact
chienh@musc.edu

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