Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorSharif Medical Research Center

About this trial

The goal of this clinical trial is to learn if the laser works to improve wound healing and bone regeneration after tooth extraction. The main question it aims to answer is:

Does laser therapy improve wound healing and bone regeneration after tooth extraction?

Researchers will compare a laser to sham laser therapy to see if the laser enhances wound healing and bone regeneration.

Participants will:

Have exposure to laser or sham laser therapy immediately after tooth extraction Record their pain intensity on days 2, 4, 6 and 14 Visit the clinic after 10 days for follow-up Again, visit the clinic after 4 months for evaluation

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

At least 21 years old, regardless of gender

Non-traumatic tooth extraction of the lower jaw is indicated

Willing for dental implant surgery

Dental appointments are available at the study place

Disqualifiers

Pregnant, lactating, and menopausal women

Smokers

Those having head and neck radiotherapy

Those with any sort of acute infection (e.g., periodontal abscess), immune deficiency, or metabolic conditions such as diabetes mellitus and osteoporosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diode Laser 980 nm.

    Other intervention

    A Diode laser is commonly used in simple surgical procedures on soft tissue, such as skin or mucosa. Its tip can work when non-activated, causing inductive effects, and when activated, it causes the ablation of soft tissue.

Treatment groups

44 Participants
are divided into 4 treatment groups
Group A: Low level laser therapy (LLLT)Experimental treatment 1 intervention
Group B: High intensity laser therapy (HILT)Experimental treatment 1 intervention
Group C: Low level laser therapy+ high intensity laser therapyExperimental treatment 1 intervention
Group D: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Wound healing will be assessed in both the experimental and control groups.

Wound healing will be assessed using the Landry, Turnbull, and Howley index after 7 days, and a score will be given ranging from 1 to 5, where 1 indicates very poor healing, and 5 indicates excellent healing. (score range: 1-very poor, 2-poor, 3-good, 4-very good, 5-excellent)

Time frame
1 year
2

Bone regeneration will be assessed in both the experimental and control groups.

A postoperative cone beam computed tomography (CBCT) will be taken immediately after extraction, followed by a CBCT 4 months after extraction. The immediate CBCT will be done to study the density of healthy bone in the apical region of the extracted tooth socket. This value will serve as the baseline for further assessment. The density obtained will then be compared with the bone formed at the end of 4 months in the extraction socket with and without laser therapy. Taking mean readings in the grayscale measurements from the periapical region will allow for the calculation of bone density.

Time frame
1 year

Secondary outcomes

1

Pain intensity will be measured in both the experimental and control groups.

The Visual Analogue Scale (VAS) will assess pain intensity at post-extraction days 2, 4, 6, and 14. It consists of a 10 cm line with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). VAS is a system that classifies a score of 1 to 4 (on a 0-10 scale) as mild pain, 5 to 6 as moderate pain, and 7 to 10 as severe pain.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sharif Medical Research Center

Lead sponsor

Universiti Sains Malaysia

Collaborator