Plain English Summary
Background and study aims
This study aims to compare using glue or suturing (stitches) to hold gum tissue in place during gum grafting surgery.
Who can participate?
Healthy adults aged 18-45 years who are non-smokers
What does the study involve?
Two pieces of gum will be grafted for each patient. One will be attached using suturing, the other with the glue. The size of the grafts, their healing and the patient's pain will be assessed afterwards.
What are the possible benefits and risks of participating?
Dentists commonly use suturing and glue in these procedures. Both are safe and should not cause any additional risks, other than those involved in the gum grafting procedure. All participants will receive the same treatment.
Where is the study run from?
Damascus University (Syria)
When is the study starting and how long is it expected to run for?
March 2019 to January 2020
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Dr Mohamed Aghiad Alhourani, email@example.com
Comparison between using tissue adhesive (N-butyl cyanoacrylate/octyl cyanoacrylate) and conventional sutures in free gingival graft surgery
We are trying to test the efficacy of a new formula of cyanoacrylate tissue adhesive (IceBerg Glue tissue adhesive), and comparing it to traditional methods in free gingival graft surgery.
Approved 04/08/2019, Damascus University Rector (Baramkeh, Damascus, Syria; +966 55 506 3806; no email), ref: 2773MS
Randomized internal-controlled trial
Primary study design
Secondary study design
Randomised parallel trial
Patient information sheet
See additional files for participant information sheet in Arabic
Free gingival (gum) graft treatment for absence or insufficiency of attached gingiva
This study is a split mouth randomized clinical trial. The patient chose a piece of paper to decide which side was to be sutured and which was to be sealed with tissue adhesive and the paper was opened just before the operation.
The patient's palate was anaesthetized. Then one long piece of the free gingival graft 1-1.5 mm thickness was harvested from the palate (from the second molar to the first pre-molar), then it was divided into two equal pieces for the vestibuloplasty. The grafted area was made by a small blade to gain a depth about 10 mm and was extended along the targeted area on two sides.One piece was fixed in its bed using nylon sutures. The other one was put in its bed and the dentist held his finger on it for 5 min to encourage its initial stability. Then 4 drops of the tissue adhesive "IceBerg Glue" were applied.
Patients returned after 1 week to have the sutures removed. They were followed up at 2 weeks, 1 month, 2 months, 3 months, and 6 months.
Primary outcome measure
Shrinkage of the graft assessed using at 2 months, 3 months and 6 months. A standard sizing template of known size is placed beside the graft and digital photographs are taken. Software is used to calculate the size of the graft by comparing it with the template in the images.
Secondary outcome measures
1. Recipient site healing assessed using the modified early-wound healing index (MEHI) at 1 week, 2 weeks, 1 month and 2 months
2. Recipient site pain assessed by the patient using a 1-10 visual analogue scale at 6 h, 12 h, 24 h, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days after surgery
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Attached gingiva ≤1 mm
2. No systemic diseases
4. Gingival inflammation and plaque indexes <20% at time of surgery
5. Aged 18-45 years
Target number of participants
Participant exclusion criteria
1. Systemic disease that would interfere with the healing process
2. Has undergone previous periodontal surgery
3. Poor endodontic treatment
4. Tooth mobility
5. Severe gingival pigmentation
9. Receiving diuretic treatment
10. Taking hormone alternatives
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Department of Periodontology Mazzah High Way
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
After finishing the follow up procedure and writing the article, I am planning to publish it (with all results, statistical analysis and some photos) in Damascus University's journal, and many other international journals.
IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from Dr.Mhd Aghiad Alhourani (firstname.lastname@example.orgemail@example.com) or the Higher Education Council at Damascus University by application in person. All photos for all the participants will be available, along with all the data and the statistical analysis after Dr Alhourani has finished follow-up and collected all the data.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
- ISRCTN10301784_PIS_02Jan2020.pdf Uploaded 02/01/2020