Tooth ExtractionNCT06552936
Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets
A study testing Diode Laser 980 nm. in people with Tooth Extraction, run by Sharif Medical Research Center at 2 sites in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Diode Laser 980 nm.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Dec 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites, 2 recruiting
- Recruiting
Sharif Medical and Dental College
Lahore, Punjab Province, 54000
Amna N Professor, +923215606840, dr.anauman@gmail.com
Nauman R Khan, +923214894164 ext. Khan, dr.anauman@gmail.com
- Recruiting
Sharif Medical and Dental College
Lahore, 54000
Amna Nauman, +923215606840, dr.anauman@gmail.com
About this study
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
- Being tested
- Diode Laser 980 nm.
- Keywords
- Tooth socket, Laser, wound healing, bone regeneration, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Diode Laser 980 nm. |
| Low level laser therapy+ high intensity laser therapy | Experimental | The patient will receive a combination of LLLT and HILT. Receives: 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. Receives: Other: Diode Laser 980 nm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start15 Dec 2024
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharif Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Responsible party
- Principal investigator, Amna Nauman, Sharif Medical Research Center
- Investigators
- Amna N Khan, MPhil, Principal investigator, Sharif Medical and Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552936
- Sponsor's protocol ID
- SMDC/SMRC/242-22
- Status last verified
- May 2025
- First submitted
- 9 Aug 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy Effect of Laser on Wound Healing and Bone Regeneration of Dental Sockets
- ClinicalTrials.gov ID
- NCT06552936
- Acronym / sponsor ID
- SMDC/SMRC/242-22
- Conditions
- Tooth Extraction
- Keywords
- Tooth socket, Laser, wound healing, bone regeneration, pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sharif Medical Research CenterUniversity, hospital or other
- Collaborators
- Universiti Sains Malaysia
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low level laser therapy (LLLT) | Experimental | Other: 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. |
| High intensity laser therapy (HILT) | Experimental | Other: 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). |
| Low level laser therapy+ high intensity laser therapy | Experimental | Other: Diode Laser 980 nm.The patient will receive a combination of LLLT and HILT. |
| Control | Sham comparator | Other: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control, High intensity laser therapy (HILT), Low level laser therapy (LLLT), Low level laser therapy+ high intensity laser therapy |
Primary outcome
Wound healing will be assessed in both the experimental and control groups.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Pain intensity will be measured in both the experimental and control groups.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amna N Khan, MPhil principal investigator
Sharif Medical and Dental College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode Laser 980 nm. in people with Tooth Extraction, run by Sharif Medical Research Center at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor (+923215606840, dr.anauman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing will be assessed in both the experimental and control groups. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.