Oral Inflammation, Photobiomodulation, Post-operative Pain Management, Tooth Extraction Site Healing, Wound Healing and Prevention
Conditions
Keywords
Inflammation, Periodontal Disease, low-level laser therapy, gingival healing, Post-operative pain
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.
Interventions
OTHERLow-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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory markers in saliva | 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 | 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 | 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) |
Countries
United States
Contacts
Primary ContactPinar Emecen-Huja
Outcome results
None listed