NCT06543199

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8 months

First QC Date

August 4, 2024

Last Update Submit

September 11, 2024

Conditions

Keywords

palatal wound healinghyaluronic acidHypericum perforatum L

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

EXPERIMENTAL

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

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.

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

HYALURONIC ASID

EXPERIMENTAL

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 siteProcedure: wound healing monitoring

Interventions

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

HYALURONIC ASID

Hyperıcum perforatum L ajanının lokal kullanımının yara iyileşmesine etkisinin değerlendirilmesi

HYPERICUM PERFORATUM L

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

CONTROLHYALURONIC ASIDHYPERICUM PERFORATUM L

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsthe fact that wound healing in the oral region is more difficult in women compared to men in this surgery.
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

MeSH Terms

Conditions

Wounds and Injuries

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

Locations