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

Not Applicable

Recruiting

• Conditions: Tooth Extraction
• Interventions: Other: Diode Laser 980 nm.

• Registration Number: NCT06552936
• Lead Sponsor: Sharif Medical Research Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-14
• Study Start: 2024-12-15
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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
• Absence of active infection at the extraction site
• Signed informed permission is provided.

Exclusion Criteria

• 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
• Patients will also be eliminated if they have a complication during surgery, such as bleeding or operational difficulties, or if the procedure takes longer than 90 minutes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low level laser therapy+ high intensity laser therapy	Diode Laser 980 nm.	The patient will receive a combination of LLLT and HILT.
High intensity laser therapy (HILT)	Diode Laser 980 nm.	HILT will be done directly after extraction when the extraction socket is filled with blood (without oozing). It will be conducted with the help of an un-initiated 300-micron tip running at the 2-watt (W) power output. It will be in a continuous emission mode (CW).
Control	Diode Laser 980 nm.	The patient will have the identical treatment as the experimental group but with the laser device in the non-activated phase.
Low level laser therapy (LLLT)	Diode Laser 980 nm.	The LLLT phase will be done with an uninitiated 300-micron tip at 0.5 W in a CW. For this phase, the tip will be kept apart from the targeted tissue by 1mm in the scanning motion.

Primary Outcome Measures

Name	Time	Method
Wound healing will be assessed in both the experimental and control groups.	1 year	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)
Bone regeneration will be assessed in both the experimental and control groups.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Pain intensity will be measured in both the experimental and control groups.	1 year	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.

Trial Locations

Locations (1)

Sharif Medical and Dental College; 🇵🇰 Lahore, Pakistan