Effect of Cyanoacrylate and Concentrated Growth Factor on Palatal Donor Site

June 13, 2024 updated by: Dicle Altındal, Yuzuncu Yıl University

Effect of Cyanoacrylate and Concentrated Growth Factor on Wound Healing and Patient Comfort at the Palatal Donor Site

The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after free gingival graft (FGG) operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and concentrated growth factor (CGF) applications.

Study Overview

Status

Recruiting

Detailed Description

Free gingival graft obtained in the palatal region causes morbidity. Therefore, clinicians try to overcome these difficulties by isolating the wound in the palatal region from the oral environment and/or accelerating wound healing.

Periodontal dressings, acrylic stents, hemostatic agents, surgical sponges, platelet concentrates, low-level laser therapy, photobiomodulation, cyanoacrylate tissue adhesives and hyaluronic acid are some of the methods used for donor site management or to accelerate healing.

Cyanoacrylate adhesives form an adhesive film through rapid polymerization triggered by the hydroxyl groups on the surfaces to which they are applied. They have both bacteriostatic and hemostatic properties.

In recent years, it has been observed that the use of platelet concentrates such as Platelet Rich Plasma (PRP), Platelet Rich Fibrin (PRF) and autogenous products such as CGF (concentrated growth factor) in periodontal treatments has increased.

CGF is obtained by centrifuging blood in four different cycles and times. This product contains a relatively intact fibrin clot containing platelets, leukocytes, various growth factors and cytokines. CGF can be applied as a carrier of growth factors and/or a barrier membrane to aid tissue regeneration and wound healing in clinical applications.

The aim of this planned randomized controlled clinical study is to evaluate the morbidity of the palatal donor area after FGG operations. In this study, wound healing and pain levels in the palatal region will be evaluated after cyanoacrylate and CGF applications.

Study Type

Interventional

Enrollment (Estimated)

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 Contact

Study Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • systemically healthy
  • not had periodontal surgery in the last 6 months

Exclusion Criteria:

  • smoker
  • allergic to medication
  • high anxiety (using modified dental anxiety scale)

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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 (Control group)
After FGG is taken from the palatal area, the sponge is placed in the wound area.
The palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel.
Active Comparator: Group 2 (Cyanoacrylate group)
After the FGG is taken from the palatal area, a cyanoacrylate tissue adhesive is placed in the wound area.
The palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel.
Active Comparator: Group 3 (Concentrated Growth Factor group)
After the FGG is taken from the palatal area, concentrated growth factor (CGF) group is placed in the wound area. CGF is obtained by centrifuging blood in four different cycles and times.
The palatal area is anesthetized using local anesthesia. The free gingival graft (FGG) is taken from the donor site with a scalpel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.
The patient is given a form to record the post-operative pain level in the palatial area with Visual analogue scale (VAS). The VAS is a scale that rates pain severity from 0 to 10. (0 = no pain to 10 = severe pain)
The pain level is recorded every hour for the first 8 hours after the operation, and on the 2nd, 3rd, 4th, 5th, 6th, 7th days after the operation.
Epithelialization
Time Frame: The epithelialization is examined on the 7th, 14th, 21st, and 28th days
Hydrogen peroxide is used to detect epithelialization in the donor area after the operation. If epithelialization is not completed, H2O2 affects the catalase enzyme in the connective tissue and releases water and oxygen. Thus, clinically, it forms blisters on the palatal wound surface. Epithelialization scores will be divided into three groups: absent, partially epitheliazed and completely epithelialized.
The epithelialization is examined on the 7th, 14th, 21st, and 28th days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesic drugs
Time Frame: Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Patients are asked to note the number of analgesics they took for pain during the first week.
Number of analgesic drugs is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Healing Index
Time Frame: The Healing Index is recorded on the 7th day.
The Healing Index is recorded with a 5-level score ranging from 1 (very poor) to 5 (excellent).
The Healing Index is recorded on the 7th day.
Color Match
Time Frame: The color match is evaluated on the 7th, 14th, 21st and 28th days.
The color match is evaluated by Visual analogue scale (VAS). (0: no color match, 10: perfect color match)
The color match is evaluated on the 7th, 14th, 21st and 28th days.
Secondary Bleeding
Time Frame: Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.
Post-operative bleeding in the palatal region is noted. The patient notes the postoperative bleeding status of the palatal area. Bleeding scores are recorded as yes or no.
Post-operative bleeding is recorded on the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th days.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Dicle Altindal, DDS, Van uzuncu Yil University
  • Study Chair: Elif Tore Sari, PhD, Van uzuncu Yil University
  • Study Chair: Nazli Zeynep Alpaslan, PhD, Van uzuncu Yil University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 2, 2024

Primary Completion (Estimated)

August 29, 2024

Study Completion (Estimated)

October 15, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 28.02.2024/07

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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