Clinical trial
Comparison of the Effects of Topical Hyaluronic Acid and Laser Application on Healing in Children After Tooth Extraction
Name
2015-KAEK-43-19-25
Description
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.
Trial arms
Trial start
2023-02-27
Estimated PCD
2023-08-01
Trial end
2023-11-01
Phase
Early phase I
Treatment
Hyaluronic Acid Topical Gels
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.
Arms:
Group 1
Diode Laser Biostimulation
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.
Arms:
Group 2
Size
60
Primary endpoint
Wound healing
One month
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
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Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-03-13
1 organization
1 product
2 indications
Organization
Atlas UniversityProduct
Hyaluronic AcidIndication
Wound Healing