Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000342718
Ethics application status
Approved
Date submitted
14/08/2021
Date registered
24/02/2022
Date last updated
24/02/2022
Date data sharing statement initially provided
24/02/2022
Date results information initially provided
24/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cyanoacrylate versus suture for palatal fibromucosa healing
Scientific title
Comparison between tissue adhesive cyanoacrylate and suture for palatal fibromucosa healing: a randomized controlled study
Secondary ID [1] 305043 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing in the palatal donor area 323223 0
Condition category
Condition code
Oral and Gastrointestinal 320809 320809 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 321961 321961 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Grafts will be harvested by means of the epithelial-connective tissue graft technique described by Zucchelli et al, gauze soaked in saline solution will be used to apply pressure on the donor surface for 5 min until the bleeding was controlled. Once the bleeding ceased, the surgeon will apply the two layers of cyanoacrylate tissue adhesive. No additional hemostatic procedure will be used. This process takes approximately 30 minutes.
Intervention code [1] 321437 0
Treatment: Surgery
Comparator / control treatment
Grafts will be harvested by means of the epithelial-connective tissue graft technique described by Zucchelli et al, gauze soaked in saline solution will be used to apply pressure on the donor surface for 5 min until the bleeding was controlled. Once the bleeding ceased, the surgeon will apply the suture. No additional hemostatic procedure will be used. This process takes approximately 30 minutes.
The sutures will be removed after a week.
Control group
Active

Outcomes
Primary outcome [1] 328615 0
Spontaneous bleeding (no/yes) assessed using participant self-report
Timepoint [1] 328615 0
During the first 7 dayspost-surgery assessed using participant self-report
Secondary outcome [1] 399639 0
Operative time assessed using a stopwatch at the time of the procedure
Timepoint [1] 399639 0
From the start of cyanoacrylate adhesive application or the picking up of the needle holder until the end of the corresponding palatal wound treatment
Secondary outcome [2] 399640 0
Postoperative pain; evaluated on a VAS (Visual Analog Scale) (0= no pain to 10=worst imaginable pain)
Timepoint [2] 399640 0
Evaluated on a VAS at the same time of day; every day for 7 days and at 14 days post-surgery
Secondary outcome [3] 399641 0
Inflammation degree, measured on a verbal rating scale (VRS) (0=no inflammation, 1 =slight inflammation, 2= marked inflammation, and 3= extreme inflammation)
Timepoint [3] 399641 0
At 7, 14, and 21 days post-surgery
Secondary outcome [4] 399642 0
Hyperesthesia; using a VRS (1 =none; 2=mild, with no interference in normal life activities; and 3=severe, with interference in normal life activities)
Timepoint [4] 399642 0
At 7, 14, and 21 days and 2 months post-surgery
Secondary outcome [5] 399643 0
Palatal mucosa necrosis (no/yes) assessed upon examination by surgeon
Timepoint [5] 399643 0
At 7, 14, and 21 days post-surgery
Secondary outcome [6] 399644 0
This is a composite secondary outcome. Healing over time; up to the formation of the first epithelial layer as evaluated visually and by pressure with periodontal probe, and the time of restitutio ad integrum of the treated palatal fibromucosa, through weekly check-ups of the patient.
Timepoint [6] 399644 0
At 7, 14, and 21 days post-surgery and 2 months post-surgery

Eligibility
Key inclusion criteria
Study inclusion criteria will be: age between 18 and 60 years, low-moderate anesthetic risk (ASA I-II), no smoking habit or <10 cigarettes/day, absence of active periodontal disease and patients requiring a connective tissue graft.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The group assignation of each patient will be communicated to the operator in a sealed envelope that will be opened immediately after completing the graft extraction procedure
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be assigned to the test (cyanoacrylate) or control (suture) group using a computer-generated randomization sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
- n= 24, the sample size was estimated to obtain statistical power of 99% and significance level of 99% to detect a reduction in bleeding of 40% in the treatment versus control group, considering a sample size ratio of control to experimental groups of 1.5.
- SPSS v 24.0 (SPSS Inc., Chicago, IL) will be used for the statistical analysis. In the descriptive analysis of the results for each group, contingency tables and bar charts will be constructed for qualitative variables, and mean values with standard deviation (SD) and standard error of the mean, median, minimum, and maximum values and quartiles will be calculated for quantitative variables. The normality of variable distribution will be checked using the Shapiro-Wilk test.
The Mann-Whitney U test will be used to compare quantitative variables (times, pain) and Fisher’s exact test (2x2 tables) or the chi-square test to compare qualitative variables (bleeding, inflammation, healing) between groups. a = 0.05 will be considered significant in all tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/01/2019
Date of last participant enrolment
Anticipated
Actual
23/12/2020
Date of last data collection
Anticipated
Actual
23/02/2021
Sample size
Target
24
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 24040 0
Spain
State/province [1] 24040 0
Granada

Funding & Sponsors
Funding source category [1] 309434 0
Self funded/Unfunded
Name [1] 309434 0
Country [1] 309434 0
Primary sponsor type
University
Name
Department of Stomatology, Faculty of Dentistry, University of Granada.
Address
Campus Universitario de Cartuja s/n 18071. Granada
Country
Spain
Secondary sponsor category [1] 310405 0
None
Name [1] 310405 0
Address [1] 310405 0
Country [1] 310405 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309232 0
Ethics Committee of the University of Granada
Ethics committee address [1] 309232 0
Campus Universitario de Cartuja s/n. Granada, 18071
Ethics committee country [1] 309232 0
Spain
Date submitted for ethics approval [1] 309232 0
Approval date [1] 309232 0
23/12/2020
Ethics approval number [1] 309232 0
nº 1870/CEIH/2020

Summary
Brief summary
The main objective of this study was to compare bleeding between the cyanoacrylate tissue adhesive and suture groups, and secondary objectives were to compare operative time, postoperative complications in the palatal donor area, and time to wound healing in de-epithelialized gingival grafts between them.
The null hypotheses were as follows: there is no difference in bleeding between the cyanoacrylate and suture; there are no differences in operative time, postoperative complications, and time to wound healing in the palatal donor area.
Trial website
Trial related presentations / publications
Public notes
The date of the ethics committee is later than the start of the study because there was a problem with the registration number. The committee was approved before starting with the first patient, however, the registration number assigned to him belonged to another. The application began again, and with COVID-19 it was delayed to date 23/12/2020

Contacts
Principal investigator
Name 113434 0
Prof Maria Victoria Olmedo-Gaya
Address 113434 0
School of Dentistry, University of Granada
Campus Universitario de Cartuja s/n
18071, Granada
Spain
Country 113434 0
Spain
Phone 113434 0
+34 958249652
Fax 113434 0
Email 113434 0
[email protected]
Contact person for public queries
Name 113435 0
Prof Maria Victoria Olmedo-Gaya
Address 113435 0
School of Dentistry, University of Granada
Campus Universitario de Cartuja s/n
18071, Granada
Spain
Country 113435 0
Spain
Phone 113435 0
+34 958249652
Fax 113435 0
Email 113435 0
[email protected]
Contact person for scientific queries
Name 113436 0
Prof Maria Victoria Olmedo-Gaya
Address 113436 0
School of Dentistry, University of Granada
Campus Universitario de Cartuja s/n
18071, Granada
Spain
Country 113436 0
Spain
Phone 113436 0
+34 958249652
Fax 113436 0
Email 113436 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.