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

NCT ID: NCT06543199

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2024-08-28

Brief Summary

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.

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.

Conditions

Wound Healing Disorder; Palate; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONTROL

Group in which no agent was used in the area left for secondary healing at the donor site.

Group Type: EXPERIMENTAL

wound healing monitoring

Intervention Type: PROCEDURE

Doctor visit on days 3, 7, 14, 21 and 28

HYPERICUM PERFORATUM L

Group using hypericum perforatum L agent in the area left for secondary healing at the donor site.

Group Type: EXPERIMENTAL

Local application of hypericum perforatum L to the wound site

Intervention Type: PROCEDURE

Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi

wound healing monitoring

Intervention Type: PROCEDURE

Doctor visit on days 3, 7, 14, 21 and 28

HYALURONIC ASID

Group using hyaluronıc acid agent in the area left for secondary healing at the donor site.

Group Type: EXPERIMENTAL

local application of hyaluronic acid agent to the wound site

Intervention Type: PROCEDURE

Evaluation of the effect of local use of hyaluronic acid agent on wound healing

wound healing monitoring

Intervention Type: PROCEDURE

Doctor visit on days 3, 7, 14, 21 and 28

Interventions

local application of hyaluronic acid agent to the wound site

Evaluation of the effect of local use of hyaluronic acid agent on wound healing

Intervention Type: PROCEDURE

Local application of hypericum perforatum L to the wound site

Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi

Intervention Type: PROCEDURE

wound healing monitoring

Doctor visit on days 3, 7, 14, 21 and 28

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Tugba Aydin

associate professor doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tuğba Aydın

Erzurum, Hiçbiri Seçilmedi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

421

Identifier Type: -

Identifier Source: org_study_id