Impact of Nd:YAG Laser Photobiostimulation on Healing of Gingiva

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Untreated periodontal disease

Acute infection of the teeth

Use of antibiotics within the last three months.

Pregnant or lactating women

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-level laser therapy

    Other intervention

    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.

Treatment groups

39 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From day of tooth extraction through day 7
2

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.

Time frame
From the day of tooth extraction to day 42
3

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)

Time frame
From post-operative day 3 to day 14

Secondary outcomes

Other outcomes

Sponsors and contacts

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