Condition category
Oral Health
Date applied
20/12/2019
Date assigned
02/01/2020
Last edited
03/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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, agheadhou@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohamed Aghiad Alhourani

ORCID ID

http://orcid.org/0000-0002-0444-7091

Contact details

Tanzeem Kafafrsouseh - Building N.244
Damascus
-
Syria
+963 992325732
agheadhou@hotmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

MS2773

Study information

Scientific title

Comparison between using tissue adhesive (N-butyl cyanoacrylate/octyl cyanoacrylate) and conventional sutures in free gingival graft surgery

Acronym

Study hypothesis

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.

Ethics approval

Approved 04/08/2019, Damascus University Rector (Baramkeh, Damascus, Syria; +966 55 506 3806; no email), ref: 2773MS

Study design

Randomized internal-controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files for participant information sheet in Arabic

Condition

Free gingival (gum) graft treatment for absence or insufficiency of attached gingiva

Intervention

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.





Intervention type

Procedure/Surgery

Phase

Drug names

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

16/03/2019

Overall trial end date

10/01/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Attached gingiva ≤1 mm
2. No systemic diseases
3. Non-smoker
4. Gingival inflammation and plaque indexes <20% at time of surgery
5. Aged 18-45 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

12

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
6. Pregnant
7. Radiation-exposed
8. Alcoholic
9. Receiving diuretic treatment
10. Taking hormone alternatives
11. Immunocompromised

Recruitment start date

06/04/2019

Recruitment end date

10/06/2019

Locations

Countries of recruitment

Syria

Trial participating centre

Damascus University
Department of Periodontology Mazzah High Way
Damascus
-
Syria

Sponsor information

Organisation

Damascus University

Sponsor details

Alabaramkeh
Damascus
-
Syria
+963 1133923192
info@damascusuniversity.edu.sy

Sponsor type

University/education

Website

http://damasuniv.edu.sy/

Funders

Funder type

University/education

Funder name

Damascus University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 (agheadhou@hotmail.com/dr.aghiadalhourani@hotmail.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

15/03/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/01/2020: The plain English summary has been added. 02/01/2020: The participant information sheet has been uploaded. 02/01/2020: Trial's existence confirmed by Damascus University.