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The Effects of Zn-containing Granulate on Patient Morbidity and Wound Healing After Free Gingival Graft Surgery

Not Applicable
Completed
Conditions
Surgery
Interventions
Procedure: Hemostatic agent suturing
Procedure: Zn granulate stent after FGG surgery
Registration Number
NCT05684913
Lead Sponsor
Cukurova University
Brief Summary

There is no study in the literature showing the effects of Zn on wound healing after free gingival graft (FGG) operation. The aim of this randomized clinical study was to compare the early healing results of the palatal wound after FGG harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic Zn-containing granules which was prepared chairside.

Detailed Description

There are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.The highest pain level perceived in the palatal region after the FGG operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. Although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
60
Inclusion Criteria
  • Periodontal and systemically healthy

    • ≥19 years old
    • Amount of attached gingival width in the maxillary or mandibular anterior region <2 mm
    • Full mouth plaque index score, bleeding index score on full-mouth probing <15%

Exclusion criteria;

  • Previously undergone surgery for a graft harvested from the palate
  • Presence of systemic disease
  • Taking medication known to interfere with periodontal health
  • Smoking
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Hemostatic agent groupHemostatic agent suturingThe patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery.
Zinc granulate groupZn granulate stent after FGG surgeryThe patients in this group will receive a chair-side prepared surgical stent from Zn granulates on the palatal wound after FGG surgery.
Primary Outcome Measures
NameTimeMethod
Post-operative painpost operative 8 weeks

Pain was scored from 0 to 10 experienced by the patients as a result of palatal wound (0: no pain, 1: minimal pain, 10: severe pain).

Secondary Outcome Measures
NameTimeMethod
Bleedingpost operative 7 days

Bleeding of the palatal wound was described as prolonged hemorrhaging after the surgery and was recorded 'yes' or 'no'

Burning sensationpost operative 8 weeks

BS was assessed as the level of sense of burning of the palatal wound via Visual Analogue Scale (0:absent 10:severe burning)

Change in dietary habitspost operative 8 weeks

evaluated according to inability to chew resulting from the presence of the palatal wound via Visual Analogue Scale (0: no changes 10: not capable of eating)

Patient discomfortpost-operative 8 weeks

PD was assessed by application of air spray for 5 seconds over the palatal site and then patients scored the VAS considering sensitive function (0: no discomfort, 10: extreme).

Complete epithelizationpost-operative 8 weeks

evaluated clinically with the 3% Hydrogen Peroxide test. While the H2O2 epithelial barrier is intact, it doesn't diffuse into the connective tissue, and oxygen isn't released. The absence of bubbles after H2O2 application was considered as CE positive, and CE was recorded as a triple variable

Trial Locations

Locations (1)

Cukurova University Faculty of Dentistry

🇹🇷

Adana, Turkey

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