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

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

Study Overview

• Status: Recruiting
• Conditions: Tooth Extraction
• Intervention / Treatment: Other: Diode Laser 980 nm.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Professor; Phone Number: +923215606840; Email: dr.anauman@gmail.com
• Study Contact Backup: Name: Nauman R Khan, MPhil; Phone Number: +923214894164; Email: dr.nrkhan@gmail.com

Study Locations

• Pakistan
  • Lahore, Pakistan, 54000
    • Recruiting
    • Sharif Medical and Dental College
    • Contact: Amna Nauman; Phone Number: +923215606840; Email: dr.anauman@gmail.com
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Recruiting
      • Sharif Medical and Dental College
      • Contact: Amna N Professor; Phone Number: +923215606840; Email: dr.anauman@gmail.com
      • Contact: Nauman R Khan; Phone Number: Khan +923214894164; Email: dr.anauman@gmail.com
      • Principal Investigator: Amna N Khan, MPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low level laser therapy (LLLT); 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.	Other: Diode Laser 980 nm.; 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.
Experimental: High intensity laser therapy (HILT); 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).	Other: Diode Laser 980 nm.; 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.
Experimental: Low level laser therapy+ high intensity laser therapy; The patient will receive a combination of LLLT and HILT.	Other: Diode Laser 980 nm.; 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.
Sham Comparator: Control; The patient will have the identical treatment as the experimental group but with the laser device in the non-activated phase.	Other: Diode Laser 980 nm.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Sharif Medical Research Center
• Collaborators: Universiti Sains Malaysia
• Investigators: Principal Investigator: Amna N Khan, MPhil, Sharif Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Tooth socket, Laser, wound healing, bone regeneration, pain
• Other Study ID Numbers: SMDC/SMRC/242-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No