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The Effects of Topical Hyaluronic Acid and Laser Application on Wound Healing in Children

Primary Purpose

Wound Heal, Tooth Extraction Status Nos

Status
Enrolling by invitation
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Hyaluronic Acid Topical Gels
Diode Laser Biostimulation
Sponsored by
Atlas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Wound Heal

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Presence of systemic disease Deciduous teeth with highly resorbed roots Use of antibiotics in the last 6 months -

Sites / Locations

  • Istanbul Atlas University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group 1

Group 2

Control Group

Arm Description

Hyaluronic acid gel will be applied to the extraction site of the patients in group 1 immediately after the extraction.

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.

Outcomes

Primary Outcome Measures

Wound healing
Healing index of Landry will be used

Secondary Outcome Measures

Post-operative pain
VAS pain scale data and number of painkillers used (if any) will be recorded

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Atlas University
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1. Study Identification

Unique Protocol Identification Number
NCT05765240
Brief Title
The Effects of Topical Hyaluronic Acid and Laser Application on Wound Healing in Children
Official Title
Comparison of the Effects of Topical Hyaluronic Acid and Laser Application on Healing in Children After Tooth Extraction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlas University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Tooth Extraction Status Nos

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Hyaluronic acid gel will be applied to the extraction site of the patients in group 1 immediately after the extraction.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid Topical Gels
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Diode Laser Biostimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing
Description
Healing index of Landry will be used
Time Frame
One month
Secondary Outcome Measure Information:
Title
Post-operative pain
Description
VAS pain scale data and number of painkillers used (if any) will be recorded
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Presence of systemic disease Deciduous teeth with highly resorbed roots Use of antibiotics in the last 6 months -
Facility Information:
Facility Name
Istanbul Atlas University
City
Istanbul
State/Province
Kağıthane
ZIP/Postal Code
34403
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Topical Hyaluronic Acid and Laser Application on Wound Healing in Children

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