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Completed

NCT Number: NCT05684913

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

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.

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Key information

Conditions

Surgery Hemorrhage Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University Faculty of Dentistry

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zn granulate stent after FGG surgery

Procedure

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

Procedure

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.

Primary outcomes

  1. Post-operative pain

    Time frame: post 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 outcomes

  1. Bleeding

    Time frame: post operative 7 days

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

  2. Burning sensation

    Time frame: post 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)

  3. Change in dietary habits

    Time frame: post 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)

  4. Complete epithelization

    Time frame: post-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

  5. Patient discomfort

    Time frame: post-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).

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Cukurova University Faculty of Dentistry

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2023
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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