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Efficacy of Cyanoacrylate Tissue Adhesive (GLUBRAN® Tiss 2) Versus CoePak Periodontal Dressing on Palatal Wound After Following Free Gingival Graft Harvesting: A Randomized Double-Blind Clinical Trial

Protocol summary

Study aim
Comparison of the efficacy of GLUBRAN® Tiss 2 cyanoacrylate tissue adhesive versus CoePak periodontal dressing for palatal wound healing after free gingival graft harvesting.
Design
In this randomized clinical trial, 28 patients are divided into two groups of 14. In the control group, the palatal area is treated with 4-0 silk sutures and Coe-Pak dressing postoperatively, while the test group receives GLUBRAN® 2 adhesive. Participants are randomly allocated 1:1 using random size‑4 blocks generated via Excel software. Each participant's assignment is performed randomly by a statistician not involved in study conduct. The trial phase is interventional.
Settings and conduct
In this double‑blind randomized trial at the Department of Periodontics, Tehran University of Medical Sciences, the effect of cyanoacrylate adhesive versus periodontal dressing on palatal wound healing after free gingival graft harvest is investigated. After harvesting a 1.5‑mm thick palatal graft, the wound is covered with cyanoacrylate adhesive in the test group and with periodontal dressing in the control group. The allocation list is kept in a sealed envelope until surgery; patients and the data analyst are blinded to group assignment to minimize bias.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18–60 years, systemically healthy, non‑tobacco users Exclusion criteria: Severe gag reflex, active periodontal disease, tooth mobility, occlusal trauma, absence from follow‑up sessions, or systemic disease that prevents proper tissue healing
Intervention groups
Control group: the palatal area was treated with 4-0 silk sutures and Coe-Pak dressing after surgery. Test group: GLUBRAN® 2 tissue adhesive applied to the palatal area following surgery.
Main outcome variables
Evaluation of the patient's pain level, bleeding, and the patient's quality of life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260505069264N1
Registration date: 2026-05-17, 1405/02/27
Registration timing: prospective

Last update: 2026-05-17, 1405/02/27
Update count: 0
Registration date
2026-05-17, 1405/02/27
Registrant information
Name
farhan gholamian baee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 5950
Email address
f_gholamianb@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-03-06, 1405/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Cyanoacrylate Tissue Adhesive (GLUBRAN® Tiss 2) Versus CoePak Periodontal Dressing on Palatal Wound After Following Free Gingival Graft Harvesting: A Randomized Double-Blind Clinical Trial
Public title
Evaluation of the effect of Tissue Adhesive on Palatal Wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 18 and 60 years of age Systemically healthy (ASA I) Without consumption of cigarettes, electronic cigarettes, waterpipe, or other forms of tobacco Having a clinical need for free gingival graft surgery around a tooth or dental implant
Exclusion criteria:
Severe gag reflex Active periodontal diseases Tooth mobility Occlusal traumas Absence from follow-up sessions Systemic diseases that impair proper tissue healing or contraindicate periodontal surgery (e.g., diabetes, high-dose steroid use, pregnancy, radiotherapy, chemotherapy, coagulation disorders, or use of drugs that interfere with wound healing)
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, participants are allocated to the two groups randomly and in a 1:1 equal ratio. For this purpose, random blocks of size four are generated using Excel software, such that within each block, two participants are assigned to the intervention group and two to the control group. The determination of which individual is assigned to which group is carried out randomly by a statistician who has no role in the conduct of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The allocation list will be kept in sealed envelopes until the start of surgery. Additionally, during the study, the blinding process will be maintained for patients and the data analyst to prevent bias.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran, end of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۹۵۵۹۹۱
Approval date
2026-04-20, 1405/01/31
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1405.004

Health conditions studied

1

Description of health condition studied
Assessment of wound healing, pain intensity, and patient quality of life after palatal graft harvesting
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Assessment of patient pain intensity
Timepoint
Up to two weeks after surgery
Method of measurement
Pain intensity is measured using the VAS (Visual Analog Scale).

2

Description
Presence of bleeding
Timepoint
Up to one weeks after surgery
Method of measurement
through a questionnaire

3

Description
quality of life
Timepoint
One, two, three, and four weeks after surgery
Method of measurement
via the OHIP-14 questionnaire

Secondary outcomes

1

Description
Epithelialization of the wound area
Timepoint
One, two, three, and four weeks after surgery
Method of measurement
Via application of hydrogen peroxide (H₂O₂) to the wound and evaluation of the extent of bubbling.

2

Description
Color match of the area
Timepoint
One, two, three, and four weeks after surgery
Method of measurement
Analyzed using Adobe Photoshop CC 2017 software, the color difference between the healed area and the surrounding healthy tissue will be measured using standard colorimetric parameters, including brightness.

3

Description
Residual wound area
Timepoint
One, two, three, and four weeks after surgery
Method of measurement
Standardized images will be taken of the wound site in the palatal area using a Canon EOS 800D camera. The wound surface area will be calculated and recorded in square millimeters using ImageJ software (NIH, Bethesda, USA).

Intervention groups

1

Description
Intervention group: Patients in this group received GLUBRAN® 2 tissue adhesive on the palatal area after surgery.
Category
Treatment - Other

2

Description
Control group: Participants in this group received only 4‑0 silk sutures and Coe‑Pak periodontal dressing on the palatal area after surgery. The sutures were removed after two weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Tehran University of Medical Sciences
Full name of responsible person
Farhan Gholamian
Street address
End of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 4000
Email
dentistry@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhan Gholamian
Street address
End of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 4000
Email
dentistry@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhan Gholamian baee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North karegar blv. dental faculity of tehran university
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5950
Fax
Email
f_gholamianb@razi.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hoori Asl Roosta
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
End of North Kargar Street, before Shahid Hakim Highway, School of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 4279 4000
Email
roosta.hoori@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhan Gholamian baee
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
North karegar blv. dental faculity of tehran university
City
Tehran
Province
Tehran
Postal code
1439955934
Phone
+98 21 8801 5950
Fax
Email
f_gholamianb@razi.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document
-
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