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

NCT05765240 | Unknown Phase 1

• 1 other identifier: 2015-KAEK-43-19-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal; Tooth Extraction Status Nos

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Healing index of Landry will be used

  One month

Secondary Outcomes (1)

• Post-operative pain

  Two weeks

Study Arms (3)

Group 1

EXPERIMENTAL

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

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.

Procedure: Diode Laser Biostimulation

Control Group

NO INTERVENTION

Interventions

Hyaluronic Acid Topical Gels DRUG

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.

Group 1

Diode Laser Biostimulation PROCEDURE

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.

Group 2

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Presence of systemic disease
• Deciduous teeth with highly resorbed roots
• Use of antibiotics in the last 6 months

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Istanbul Atlas University

Istanbul, Kağıthane, 34403, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: February 27, 2023
• Primary Completion: August 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 13, 2023

Record last verified: 2023-02

Locations

TU (1)