Evaluation of the Effect of Hypericum Perforatum L and Hyaluronic Acid on Excisional Palatal Wound Healing
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2024
CompletedFirst Submitted
Initial submission to the registry
August 4, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2024
CompletedSeptember 19, 2024
September 1, 2024
8 months
August 4, 2024
September 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
CONTROL
EXPERIMENTALGroup in which no agent was used in the area left for secondary healing at the donor site.
HYPERICUM PERFORATUM L
EXPERIMENTALGroup using hypericum perforatum L agent in the area left for secondary healing at the donor site.
HYALURONIC ASID
EXPERIMENTALGroup using hyaluronıc acid agent in the area left for secondary healing at the donor site.
Interventions
Evaluation of the effect of local use of hyaluronic acid agent on wound healing
Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi
Doctor visit on days 3, 7, 14, 21 and 28
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tuğba Aydın
Erzurum, Hiçbiri Seçilmedi, 25240, Turkey (Türkiye)
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor doctor
Study Record Dates
First Submitted
August 4, 2024
First Posted
August 7, 2024
Study Start
January 2, 2024
Primary Completion
August 20, 2024
Study Completion
August 28, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share