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

January 12, 2023 updated by: Mustafa Ozcan, Cukurova University

Cukurova University Faculty of Dentistry

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • Cukurova university Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zinc granulate group
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
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.(
Active Comparator: Hemostatic agent group
The patients in this group will receive hemostatic agent sutured on the palatal wound after FGG surgery.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
post operative 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'
post operative 7 days
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)
post operative 8 weeks
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)
post operative 8 weeks
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
post-operative 8 weeks
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).
post-operative 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Director: Cenk Haytac, Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2022

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

December 10, 2022

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 13, 2023

Study Record Updates

Last Update Posted (Actual)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CukurovaU-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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