Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional Palatal Wound Healing

Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional

The free gingival graft (FGG) procedure is one of the surgical approaches used to create a large area of adherent gingiva around the tooth and implant. As part of this procedure, one SDG at a time is harvested from the donor site of the secondary healing palate. The most common postoperative complications are pain, burning sensation and delayed wound healing at the donor site. Many agents have been used for years to reduce these complications, but so far none has been emphasized as the ideal agent. In this thesis, methods to improve the healing of the hard palate, the donor site for SDG surgery, and postoperative patient comfort will be compared.

Study Overview

• Status: Completed
• Conditions: Palate; Wound; Wound Healing Disorder
• Intervention / Treatment: Procedure: wound healing monitoring; Procedure: Local application of hypericum perforatum L to the wound site; Procedure: local application of hyaluronic acid agent to the wound site

Detailed Description

The free gingival graft (FGG) procedure is one of the surgical approaches used to create a large adherent gingival and keratinized zone around teeth and implants. As part of this procedure, SDG is harvested from the palatal donor area. The most common postoperative complications from the palatal donor area left to secondary healing are pain, burning sensation and delayed wound healing at the donor site. Various hemostatic agents, dressing materials, platelet-rich fibrin and analgesics have been used for years to reduce postoperative complications, promote wound healing and increase patient comfort. However, none of them has been emphasized as the ideal agent in the relevant literature. In this thesis, we will compare the methods that will improve the healing of the hard palate, which is the donor site for SDG surgery, and postoperative patient comfort. Hypericum perforatum L and hyaluronic acid will be compared by local application to the palatal rotator area.

It is aimed to investigate the postoperative effects of topical application of Hypericum perforatum L and hyaluronic acid (trade names; HYPERICUM PERFORATUM L Dr Özberk St. John's wort oil; hyaluronic acid: Gengigel Forte Gel) on the healing of surgical wounds created in the palatal donor area after SDG and its effects on wound healing. Hyaluronic acid is a non-sulfated polysaccharide component of the glycosaminoglycan family, which is also found in joint fluids, serum and various body fluids such as saliva and gingival groove fluid. Although it is present in all periodontal tissues, it is especially prominent in non-mineralized tissues such as gingiva and periodontal ligament. The highly biocompatible and nonimmunogenic nature of the action of hyaluronic acid, its bacteriostatic, fungistatic, anti-inflammatory, antiedematous, osteoinductive and pro-angiogenetic properties leading to the promotion of wound healing in various tissues have led hyaluronic acid to be of interest in the treatment of various diseases in medical fields such as orthopedics, ophthalmology and dermatology. In dentistry, hyaluronic acid has been used in tooth extraction sockets, temporomandibular joint treatment to accelerate the healing process and to make the healing period comfortable.

Plants have always played an important role in the improvement of human health in history. Hypericum perforatum, a member of the Hypericaceae family, has been recognized as a valuable herbal medicine. This plant contains hyperforin, flavonoids and hypericin. The olive oil extract of H. perforatum has long been used as both topical and oral medicine to treat cuts, burns, depression, hemorrhoids, diabetes and gastrointestinal ulcers. Studies have shown that H. perforatum increases collagen deposition, shortens the duration of inflammation and stops the migration of fibroblasts during wound healing.

Both agents have many areas of use that have been tried and found to be effective on wound healing. It is aimed to contribute to the literature by evaluating these two agents in terms of wound healing and postoperative patient comfort in the palatal donor area and at the same time evaluating them with a control group in which no agent was used.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Hiçbiri seçilmedi
    • Erzurum, Hiçbiri seçilmedi, Turkey, 25240
      • Tuğba Aydın

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient is in need of free gingival graft (FGG) surgery,
• The patient's acceptance of the treatment,
• All oral plaque and bleeding scores less than 20%.
• Age between 18-60 years.

Exclusion Criteria:

• The patient does not need SDG surgery,
• The patient is a smoker,
• The patient has a systemic disease that will affect recovery,
• The patient is unable to attend follow-up sessions,
• Previous periodontal surgery,
• The patient is pregnant or lactating,
• The patient has used antibiotics, corticosteroids, anti-inflammatory, immunosuppressive drugs in the last 6 months.
• Tooth deficiency such that the patient cannot wear acrylic aligners
• Acute periodontal condition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CONTROL; Group in which no agent was used in the area left for secondary healing at the donor site.	Procedure: wound healing monitoring; Doctor visit on days 3, 7, 14, 21 and 28
Experimental: HYPERICUM PERFORATUM L; Group using hypericum perforatum L agent in the area left for secondary healing at the donor site.	Procedure: wound healing monitoring; Doctor visit on days 3, 7, 14, 21 and 28; Procedure: Local application of hypericum perforatum L to the wound site; Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi
Experimental: HYALURONIC ASID; Group using hyaluronıc acid agent in the area left for secondary healing at the donor site.	Procedure: wound healing monitoring; Doctor visit on days 3, 7, 14, 21 and 28; Procedure: local application of hyaluronic acid agent to the wound site; Evaluation of the effect of local use of hyaluronic acid agent on wound healing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of pain at the donor site	Measuring and recording the pain score at the donor site with a vas	Days 1,2,3,4,4,5,6,7
evaluation of burning in the donor area	Measuring and recording the burning score at the donor site with a vas	Days 1,2,3,4,4,5,6,7
evaluation of chewing discomfort at the donor site	Measuring and recording the chewing discomfort score at the donor site with a vas	Days 1,2,3,4,4,5,6,7

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 28, 2024

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: hyaluronic acid; palatal wound healing; Hypericum perforatum L
• Additional Relevant MeSH Terms: Wounds and Injuries; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• 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