Wound HealPhase 1NCT05765240
The Effects of Topical Hyaluronic Acid and Laser Application on Wound Healing in Children
A Phase 1 study testing Hyaluronic Acid Topical Gels and Diode Laser Biostimulation in people with Wound Heal and Tooth Extraction Status Nos, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
Tooth extraction is one of the major surgical procedures that can cause dental anxiety and dental fear in pediatric patients as a result of traumatic experiences. Preventing pain and infection by appropriate means during and after this application increases patient comfort and helps to develop patient cooperation for… Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Tooth Extraction Status Nos
- What is being tested?
- Hyaluronic Acid Topical Gels and Diode Laser Biostimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2023to 1 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being systemically healthy
- Having at least one primary or permanent molar extraction indication
- The fact that at least 1/3 of the primary tooth root with an extraction indication has not been resorbed
- Have not used antibiotics in the last 6 months
Who cannot join
- Presence of systemic disease
- Deciduous teeth with highly resorbed roots
- Use of antibiotics in the last 6 months
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kağıthane, 34403
About this study
Official title: Comparison of the Effects of Topical Hyaluronic Acid and Laser Application on Healing in Children After Tooth Extraction
Tooth extraction is one of the major surgical procedures that can cause dental anxiety and dental fear in pediatric patients as a result of traumatic experiences. Preventing pain and infection by appropriate means during and after this application increases patient comfort and helps to develop patient cooperation for possible future dental experiences.
In the current literature, it has been shown that topical hyaluronic acid applications have a role in reducing infection and pain.
Read more
There are also studies in the literature showing that tissue biostimulation with different doses of diode laser application accelerates wound healing by promoting cell regeneration.
Although there are studies showing that two different applications accelerate wound healing, there is no study comparing the effectiveness of these two methods. In addition, there is no study evaluating extraction wound healing in pediatric patients.
Our study will be the first to evaluate tooth extraction wound healing in pediatric patients and to compare these two methods.
Read the detailed description
Sample Size:
Our study will include 60 children aged between 5-13 years who are systemically healthy and volunteer to participate in the study, with indications for extraction of primary or permanent molars for various reasons.
In the study, the GPOWER 3.1 package program was used to determine the sufficient sample volume.
Steps followed when calculating sample volume;
1st type margin of error (α) = 0.05 The mean (1.72) and standard deviation (1.14) values of the 7th day VAS scores of the participants in the "control" group were taken into account.
The mean (0.92) and standard deviation (0.81) values of the 7th day VAS scores of the participants in the "Hyaluronic Acid (HA)" group were taken into account.
Using the relevant mean and standard deviation values, the effect size was calculated as 0.9876543.
The power of the test was taken as (1-β) = 0.80. As a result of the calculations, the sample volume that will provide the power of the test (1-β) = 0.80 was determined as 54 people in total, with a minimum of 18 in each group.
Considering the possible reductions in the follow-up process, the sample number was determined as 60 people, 20 people in each group.
Study Design:
Children with primary or permanent molar extraction indications will be divided into three as:
Group 1: Hyaluronic Acid Gel Group Group 2: Diode Laser Group The control group.
As a result of clinical and radiographic examination, the extraction of primary or permanent molar teeth will be performed by a single investigator under local anesthesia.
All patient groups will be evaluated by a single investigator at the time of the extraction and on the 7th, 14th, and 21st days following the extraction. The same investigator will perform an intraoral examination before extraction and record the caries status using DMFT and dft scoring.
Pain assessment will be made through the Wong-Baker Faces Pain Scale suitable for ages 3-18. The patient will be asked to score the pain felt at the extraction site during the period between follow-up appointments, and a total of 3 assessments will be made.
In all groups, the presence of edema and infection will be evaluated by a single investigator on the 7th, 14th, and 21st days following the extraction.
Wound dimensions (dehiscent, mesiodistal and buccolingual longest distances on the socket) will be determined by a single investigator immediately after the extraction and on the 3rd, 7th, and 14th days following the extraction, and recorded with photographs taken from a standard distance.
In the control group, the wound area will be followed without any application after tooth extraction.
Hyaluronic acid gel will be applied to the extraction site of the patients in the hyaluronic acid gel group immediately after the extraction.
In the diode laser group, the alveolar socket will be irradiated with a potency of 20mW/670 nm and an energy dose of 4 J/cm2 for 7 minutes immediately after extraction.
- Conditions
- Wound Heal, Tooth Extraction Status Nos
- Being tested
- Hyaluronic Acid Topical Gels, Diode Laser Biostimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid Topical GelsDrug
Hyaluronic acid is a linear polysaccharide found naturally in different organs and tissues such as the extracellular matrix of connective tissue, synovial fluid, embryonic mesenchyme, and skin. The periodontal ligament is a key element found in periodontal tissues such as the gingiva, alveolar bone, and cementum. It plays a regulatory role in the inflammatory response, impedes the penetration of viruses and bacteria into the tissue, and is involved in inflammation, granulation tissue formation, epithelial formation, and tissue remodeling. There are no reported drug interactions or contraindications for the use of hyaluronic acid.
Diode Laser BiostimulationProcedure or surgery
Laser therapy can amplify wound healing by increasing cell regeneration and modulating the immune response. In animal experiments with diode laser, it was observed that postoperative low-level laser application increased wound healing. Diode laser applied at frequencies of 20 mW and 670 nm and 200 mW and 820 nm accelerated clot organization and new vessel formation after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Hyaluronic acid gel will be applied to the extraction site of the patients in group 1 immediately after the extraction. Receives: Drug: Hyaluronic Acid Topical Gels |
| Group 2 | Experimental | Alveolar socket in group 2, will ve irradiated with an energy dose of J/cm2, 20mW/670 nm potency and 4 for 7 minutes immediately after extraction.
It will be irradiated with an energy dose of J/cm2. Receives: Procedure: Diode Laser Biostimulation |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Healing index of Landry will be used
Measured: One month
Secondary outcomes (1)
Post-operative pain
VAS pain scale data and number of painkillers used (if any) will be recorded
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start27 Feb 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765240
- Sponsor's protocol ID
- 2015-KAEK-43-19-25
- Status last verified
- Feb 2023
- First submitted
- 1 Mar 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Topical Hyaluronic Acid and Laser Application on Healing in Children After Tooth Extraction
- ClinicalTrials.gov ID
- NCT05765240
- Acronym / sponsor ID
- 2015-KAEK-43-19-25
- Conditions
- Wound Heal, Tooth Extraction Status Nos
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 13 Mar 2023 (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.
Tooth extraction is one of the major surgical procedures that can cause dental anxiety and dental fear in pediatric patients as a result of traumatic experiences. Preventing pain and infection by appropriate means during and after this application increases patient comfort and helps to develop patient cooperation for possible future dental experiences.
In the current literature, it has been shown that topical hyaluronic acid applications have a role in reducing infection and pain.
There are also studies in the literature showing that tissue biostimulation with different doses of diode laser application accelerates wound healing by promoting cell regeneration.
Although there are studies showing that two different applications accelerate wound healing, there is no study comparing the effectiveness of these two methods. In addition, there is no study evaluating extraction wound healing in pediatric patients.
Our study will be the first to evaluate tooth extraction wound healing in pediatric patients and to compare these two methods.
Detailed description
Sample Size:
Our study will include 60 children aged between 5-13 years who are systemically healthy and volunteer to participate in the study, with indications for extraction of primary or permanent molars for various reasons.
In the study, the GPOWER 3.1 package program was used to determine the sufficient sample volume.
Steps followed when calculating sample volume;
1st type margin of error (α) = 0.05 The mean (1.72) and standard deviation (1.14) values of the 7th day VAS scores of the participants in the "control" group were taken into account.
The mean (0.92) and standard deviation (0.81) values of the 7th day VAS scores of the participants in the "Hyaluronic Acid (HA)" group were taken into account.
Using the relevant mean and standard deviation values, the effect size was calculated as 0.9876543.
The power of the test was taken as (1-β) = 0.80. As a result of the calculations, the sample volume that will provide the power of the test (1-β) = 0.80 was determined as 54 people in total, with a minimum of 18 in each group.
Considering the possible reductions in the follow-up process, the sample number was determined as 60 people, 20 people in each group.
Study Design:
Children with primary or permanent molar extraction indications will be divided into three as:
Group 1: Hyaluronic Acid Gel Group Group 2: Diode Laser Group The control group.
As a result of clinical and radiographic examination, the extraction of primary or permanent molar teeth will be performed by a single investigator under local anesthesia.
All patient groups will be evaluated by a single investigator at the time of the extraction and on the 7th, 14th, and 21st days following the extraction. The same investigator will perform an intraoral examination before extraction and record the caries status using DMFT and dft scoring.
Pain assessment will be made through the Wong-Baker Faces Pain Scale suitable for ages 3-18. The patient will be asked to score the pain felt at the extraction site during the period between follow-up appointments, and a total of 3 assessments will be made.
In all groups, the presence of edema and infection will be evaluated by a single investigator on the 7th, 14th, and 21st days following the extraction.
Wound dimensions (dehiscent, mesiodistal and buccolingual longest distances on the socket) will be determined by a single investigator immediately after the extraction and on the 3rd, 7th, and 14th days following the extraction, and recorded with photographs taken from a standard distance.
In the control group, the wound area will be followed without any application after tooth extraction.
Hyaluronic acid gel will be applied to the extraction site of the patients in the hyaluronic acid gel group immediately after the extraction.
In the diode laser group, the alveolar socket will be irradiated with a potency of 20mW/670 nm and an energy dose of 4 J/cm2 for 7 minutes immediately after extraction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Hyaluronic Acid Topical GelsHyaluronic acid gel will be applied to the extraction site of the patients in group 1 immediately after the extraction. |
| Group 2 | Experimental | Procedure: Diode Laser BiostimulationAlveolar socket in group 2, will ve irradiated with an energy dose of J/cm2, 20mW/670 nm potency and 4 for 7 minutes immediately after extraction. It will be irradiated with an energy dose of J/cm2. |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being systemically healthy
- Having at least one primary or permanent molar extraction indication
- The fact that at least 1/3 of the primary tooth root with an extraction indication has not been resorbed
- Have not used antibiotics in the last 6 months
Key exclusion criteria (4 listed)
- Presence of systemic disease
- Deciduous teeth with highly resorbed roots
- Use of antibiotics in the last 6 months
- -
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 |
|---|---|---|
| Hyaluronic Acid Topical GelsHyaluronic acid is a linear polysaccharide found naturally in different organs and tissues such as the extracellular matrix of connective tissue, synovial fluid, embryonic mesenchyme, and skin. The periodontal ligament is a key element found in periodontal tissues such as the gingiva, alveolar bone, and cementum. It plays a regulatory role in the inflammatory response, impedes the penetration of viruses and bacteria into the tissue, and is involved in inflammation, granulation tissue formation, epithelial formation, and tissue remodeling. There are no reported drug interactions or contraindications for the use of hyaluronic acid. | Drug | Group 1 |
| Diode Laser BiostimulationLaser therapy can amplify wound healing by increasing cell regeneration and modulating the immune response. In animal experiments with diode laser, it was observed that postoperative low-level laser application increased wound healing. Diode laser applied at frequencies of 20 mW and 670 nm and 200 mW and 820 nm accelerated clot organization and new vessel formation after tooth extraction. | Procedure or surgery | Group 2 |
Primary outcome
Wound healing
Time frame: One month
Healing index of Landry will be used
1 secondary outcome
Post-operative pain
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyaluronic Acid Topical Gels and Diode Laser Biostimulation in people with Wound Heal and Tooth Extraction Status Nos, run by Atlas University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: One month). 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 13 Mar 2023.