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CompletedNCT06543199Updated Sep 19, 2024

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

An interventional study of local application of hyaluronic acid agent to the wound site and Local application of hypericum perforatum L to the wound site in Wound Healing Disorder and Palate; Wound, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2024, registered Aug 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Wound Healing Disorder
  • Palate; Wound

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Keywords

  • palatal wound healing
  • hyaluronic acid
  • Hypericum perforatum L
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 45 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    CONTROL

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

    Procedure: wound healing monitoring

  • Experimental
    HYPERICUM PERFORATUM L

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

    Procedure: Local application of hypericum perforatum L to the wound site · Procedure: wound healing monitoring

  • Experimental
    HYALURONIC ASID

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

    Procedure: local application of hyaluronic acid agent to the wound site · Procedure: wound healing monitoring

Interventions

  • Procedurelocal application of hyaluronic acid agent to the wound site

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

  • ProcedureLocal application of hypericum perforatum L to the wound site

    Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi

  • Procedurewound healing monitoring

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

06

What researchers measure

Primary outcomes

  1. assessment of pain at the donor site

    Measuring and recording the pain score at the donor site with a vas

    Time frame: Days 1,2,3,4,4,5,6,7

  2. evaluation of burning in the donor area

    Measuring and recording the burning score at the donor site with a vas

    Time frame: Days 1,2,3,4,4,5,6,7

  3. evaluation of chewing discomfort at the donor site

    Measuring and recording the chewing discomfort score at the donor site with a vas

    Time frame: Days 1,2,3,4,4,5,6,7

07

Study locations

1 site
  • Tuğba Aydın
    Erzurum, Hiçbiri seçilmedi 25240, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06543199
Lead sponsor
Ataturk University
Responsible party
Tugba Aydin (associate professor doctor, Ataturk University) — Principal investigator
First posted
Aug 7, 2024
Start date
Jan 2, 2024
Primary completion
Aug 20, 2024
Completion
Aug 28, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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