NCT05684913

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable surgery

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable surgery

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

March 20, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 13, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 14, 2022

Last Update Submit

January 12, 2023

Conditions

Surgery

Keywords

free gingival graft surgerysurgical stentzincpainbleeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Bleeding

    post operative 7 days

  • Burning sensation

    post operative 8 weeks

  • Change in dietary habits

    post operative 8 weeks

  • Complete epithelization

    post-operative 8 weeks

  • Patient discomfort

    post-operative 8 weeks

Study Arms (2)

Zinc granulate group

EXPERIMENTAL

The patients in this group will receive a chair-side prepared surgical stent from Zn granulates on the palatal wound after FGG surgery.

Procedure: Zn granulate stent after FGG surgery

Hemostatic agent group

ACTIVE COMPARATOR

The patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery.

Procedure: Hemostatic agent suturing

Interventions

Zn granulate stent after FGG surgeryPROCEDURE

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.(

Zinc granulate group
Hemostatic agent suturingPROCEDURE

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.

Hemostatic agent group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Dentistry

Adana, 01330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainHemorrhage

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Cenk Haytac

    Professor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The investigator assessing the clinical outcomes is blinded to the study groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 14, 2022

First Posted

January 13, 2023

Study Start

March 20, 2022

Primary Completion

November 15, 2022

Study Completion

December 10, 2022

Last Updated

January 13, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)