Wound Healing DisorderNCT06543199
Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional Palatal Wound Healing
A study testing local application of hyaluronic acid agent to the wound site, Local application of hypericum perforatum L to the wound site and wound healing monitoring in people with Wound Healing Disorder and Palate; Wound, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Wound Healing Disorder, Palate; Wound
- What is being tested?
- local application of hyaluronic acid agent to the wound site, Local application of hypericum perforatum L to the wound site and wound healing monitoring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 28 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Wound Healing Disorder, Palate; Wound
- Being tested
- local application of hyaluronic acid agent to the wound site, Local application of hypericum perforatum L to the wound site, wound healing monitoring
- Keywords
- palatal wound healing, hyaluronic acid, Hypericum perforatum L
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local application of hyaluronic acid agent to the wound siteProcedure or surgery
Evaluation of the effect of local use of hyaluronic acid agent on wound healing
Local application of hypericum perforatum L to the wound siteProcedure or surgery
Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi
wound healing monitoringProcedure or surgery
Doctor visit on days 3, 7, 14, 21 and 28
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Experimental | Group in which no agent was used in the area left for secondary healing at the donor site. Receives: Procedure: wound healing monitoring |
| HYPERICUM PERFORATUM L | Experimental | Group using hypericum perforatum L agent in the area left for secondary healing at the donor site. Receives: Procedure: Local application of hypericum perforatum L to the wound site; Procedure: wound healing monitoring |
| HYALURONIC ASID | Experimental | Group using hyaluronıc acid agent in the area left for secondary healing at the donor site. Receives: Procedure: local application of hyaluronic acid agent to the wound site; Procedure: wound healing monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of pain at the donor site
Measuring and recording the pain score at the donor site with a vas
Measured: 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
Measured: 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
Measured: Days 1,2,3,4,4,5,6,7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start2 Jan 2024
- Primary completion20 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound Healing DisorderStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba Aydin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543199
- Sponsor's protocol ID
- 421
- Status last verified
- Sep 2024
- First submitted
- 4 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional
- ClinicalTrials.gov ID
- NCT06543199
- Acronym / sponsor ID
- 421
- Conditions
- Wound Healing Disorder, Palate; Wound
- Keywords
- palatal wound healing, hyaluronic acid, Hypericum perforatum L
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Experimental | Procedure: wound healing monitoringGroup in which no agent was used in the area left for secondary healing at the donor site. |
| HYPERICUM PERFORATUM L | Experimental | Procedure: Local application of hypericum perforatum L to the wound site, Procedure: wound healing monitoringGroup using hypericum perforatum L agent in the area left for secondary healing at the donor site. |
| HYALURONIC ASID | Experimental | Procedure: local application of hyaluronic acid agent to the wound site, Procedure: wound healing monitoringGroup using hyaluronıc acid agent in the area left for secondary healing at the donor site. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local application of hyaluronic acid agent to the wound siteEvaluation of the effect of local use of hyaluronic acid agent on wound healing | Procedure or surgery | HYALURONIC ASID |
| Local application of hypericum perforatum L to the wound siteHyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi | Procedure or surgery | HYPERICUM PERFORATUM L |
| wound healing monitoringDoctor visit on days 3, 7, 14, 21 and 28 | Procedure or surgery | CONTROL, HYALURONIC ASID, HYPERICUM PERFORATUM L |
Primary outcome
assessment of pain at the donor site
Time frame: Days 1,2,3,4,4,5,6,7
Measuring and recording the pain score at the donor site with a vas
evaluation of burning in the donor area
Time frame: Days 1,2,3,4,4,5,6,7
Measuring and recording the burning score at the donor site with a vas
evaluation of chewing discomfort at the donor site
Time frame: Days 1,2,3,4,4,5,6,7
Measuring and recording the chewing discomfort score at the donor site with a vas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local application of hyaluronic acid agent to the wound site, Local application of hypericum perforatum L to the wound site and wound healing monitoring in people with Wound Healing Disorder and Palate; Wound, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain at the donor site (time frame: Days 1,2,3,4,4,5,6,7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.