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

NCT06552936 | Recruiting

• 1 other identifier: SMDC/SMRC/242-22
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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

Conditions

Tooth Extraction

Keywords

Tooth socket, Laser, wound healing, bone regeneration, pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  1 year

Study Arms (4)

Low level laser therapy (LLLT)

EXPERIMENTAL

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.

High intensity laser therapy (HILT)

EXPERIMENTAL

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.

Low level laser therapy+ high intensity laser therapy

EXPERIMENTAL

The patient will receive a combination of LLLT and HILT.

Other: Diode Laser 980 nm.

Control

SHAM COMPARATOR

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.

Interventions

Diode Laser 980 nm. OTHER

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.

Control; High intensity laser therapy (HILT); Low level laser therapy (LLLT); Low level laser therapy+ high intensity laser therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sharif Medical Research Center: lead
• Universiti Sains Malaysia: collaborator

Study Sites (2)

Sharif Medical and Dental College

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Sharif Medical and Dental College

Lahore, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Amna N Khan, MPhil

  Sharif Medical and Dental College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor

CONTACT

+923215606840; dr.anauman@gmail.com

Nauman R Khan, MPhil

CONTACT

+923214894164; dr.nrkhan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 14, 2024
• Study Start: December 15, 2024
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)