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

Surgery Clinical Trial

Official title:

Cukurova University Faculty of Dentistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684913
• Other study ID #: CukurovaU-4
• Status: Completed
• Phase: N/A
• Start date: March 20, 2022
• Est. completion date: December 10, 2022

Study information

• Verified date: January 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 10, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgery

Intervention

Procedure:
• Zn 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.(
• Hemostatic 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.

Locations

Country	Name	City	State
Turkey	Cukurova University Faculty of Dentistry	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	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).	post operative 8 weeks
Secondary	Bleeding	Bleeding of the palatal wound was described as prolonged hemorrhaging after the surgery and was recorded 'yes' or 'no'	post operative 7 days
Secondary	Burning sensation	BS was assessed as the level of sense of burning of the palatal wound via Visual Analogue Scale (0:absent 10:severe burning)	post operative 8 weeks
Secondary	Change in dietary habits	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)	post operative 8 weeks
Secondary	Complete epithelization	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	post-operative 8 weeks
Secondary	Patient discomfort	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).	post-operative 8 weeks