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

Cukurova University Faculty of Dentistry

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05684913
Enrollment
60
Registered
2023-01-13
Start date
2022-03-20
Completion date
2022-12-10
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

free gingival graft surgery, surgical stent, zinc, pain, bleeding

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.

Interventions

PROCEDUREZn granulate stent after FGG surgery

Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes and the ZnG was prepared according to the manufacturer guidelines. Briefly, approximately 10 grams of granulate was poured into hot water and then manually shaped to cover the surgical area. The retention was achieved from the palatal, occlusal and buccal surfaces of the teeth. The patient was asked to wear the ZnG for 7 days except for eating.(

PROCEDUREHemostatic agent suturing

Immediately after FGG harvesting from the palatal tissue, homeostasis was achieved by sterile wet gauzes. Then hemostatic agent containing cellulose were sutured on the palatal wound area with 4.0 vicryl sutures in this group. Sutures were removed after 7 days.

Sponsors

Cukurova University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The investigator assessing the clinical outcomes is blinded to the study groups

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative painpost operative 8 weeksPain 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

MeasureTime frameDescription
Bleedingpost operative 7 daysBleeding of the palatal wound was described as prolonged hemorrhaging after the surgery and was recorded 'yes' or 'no'
Burning sensationpost operative 8 weeksBS 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 weeksevaluated 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)
Complete epithelizationpost-operative 8 weeksevaluated 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
Patient discomfortpost-operative 8 weeksPD 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026