The Efficacy Of Adhesive Tissue Iceberg-Gluein Reducing Post-Operative Bleeding And Pain After Surgical Removal Of Impacted Lower Third Molars: A Randomized Clinical Trial
Mohammed Shukur1, Omar Heshmeh2, Safaa Shihabi3*
1 Msc student in Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Damascus University, Syria.
2 Professor in Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Damascus University, Syria.
3 MSc in Pediatric Dentistry, Faculty of Dentistry, Damascus University, Syria.
*Corresponding Author
Safaa Shihabi,
MSc in Pediatric Dentistry, Faculty of Dentistry, Damascus University, Syria.
Tel: 00963934101164
E-mail: safaa2671991@gmail.com
Received: September 16, 2021; Accepted: October 10, 2021; Published: October 22, 2021
Citation: Mohammed Shukur, Omar Heshmeh, Safaa Shihabi. The Efficacy Of Adhesive Tissue Iceberg-Gluein Reducing Post-Operative Bleeding And Pain After Surgical Removal Of Impacted Lower Third Molars: A Randomized Clinical Trial. Int J Dentistry Oral Sci. 2021;8(10):4806-4811. doi: dx.doi.org/10.19070/2377-8075-21000974
Copyright:Safaa Shihabi©2021. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited.
Abstract
Background: There is various wound closure techniques have been used in medical literatures like traditional non-absorbable
sutures and advanced modalities, suchas synthetic absorbable sutures, surgical staples and tissue adhesives. Suturing has been
the conventional method for approximating wound margins. However,suturing has many disadvantages leading to various
alternative material closure options.
This need to an interest in tissue adhesives such as new generation of cyanoacrylate which has unique properties lead us to
focus on this technique in our study.
Aim: Evaluation the efficacy of the adhesive tissue(iceberg-glue) in minimizing the post-operative bleeding and pain after
surgical removal of impacted lower third molars.
Materials and Methods: Sample size consisted of 19 patients with bilateral and symmetrical impacted lowers third molars
were included in this randomized, split-mouth study.
Patients with any pre-existing pathology or systemic disease were excluded.
On one random side were surgically closure using silk suture (3-0) (group A), and using an adhesive tissue on the contralateral
side (groupB). The comparison of the post-operative bleedingevaluation rated from (3hours, 6hours, 9hours, 12hours) post
surgically, and post-operative pain evaluation in (one, third, and seven days) post surgically, the bleeding and pain assessment
according to VAS scales.
Result: Bleeding assessment according to Mann-Whitney U test,the outcome reveals statistically significant differences for
adhesive group in the (3 hours, 6 hours, 9 hours) after surgery in adhesive tissue group (p<0.05) where as there is no significant
difference in (12 hours) after surgery between two groups (p>0.05), pain assessed according to T-student test which reveals
statistical significant differences in the one and third days post surgically for adhesive group and there is no differences in the
seven days between the two groups.
Conclusion: The iceberg-gluehas a significant and effective effect on hemostasis after surgical extraction of impacted lower
molars compared with traditional suture with 3-0 silk thread.
2.Introduction
3.Materials and Methods
3.Results
4.Discussion
5.Conclusion
5.References
Keywords
Surgical Extraction; Adhesive Tissue; Suture-Impacted Third Molar; Bleeding; Pain.
Introduction
Third molars are the most susceptible to impaction because they
are the last teeth to erupt, so they do not find enough space to
erupt [1]. Extraction of impacted third molars is the most common
surgical procedure in the dental clinic (Brad and Jafoo) often
characterized by the following period. Surgical extraction of
third molars in the presence of edema, hemorrhage and pain [2]
Although suturing is the common traditional method for rounding
wound edges in impacted molars, it has many disadvantages
as it can cause a permanent effect of the sutures, Swelling in the
wound and injury as a result of needle insertion in addition to
reactions due to the presence of a foreign body, the formation of
granules and isolates in tissues and infection [3]. Various alternative materials have been used to close the edges of the wound
since ancient times, as well as from human hair to surgical silk
threads Although the materials of modern surgical sutures and
the techniques used are very accurate and studied, the desired goal
of closing the wound and reducing bleeding may remain unrealized
(Kumar et al., 2013), so there is a need for alternative closure
methods. This need leads to attention in surgical plasters of cyanoacrylate
as an alternative to surgical sutures in order to close
these wounds, whose adhesive properties were first described in
1959 and presented to the Food and Drug Administration in 1964
[4].
However, the use of ethyl and methyl cyanoacrylate has been
abandoned due to its toxicity to tissues and the cause of a clear
reaction against a foreign body [5], but newer generations of cyanoacrylate
such as n-butyl-2 cyanoacrylate.octyl-2 cyanoacrylate
and isiamyl 2- cyanoacrylatel -n-butyl 2 cyanoacrylate+oca 2-octyl
cyanoacrylate.
Which is characterized by the length of the chain and therefore
the strength of toxicity and adhesion decreases, flexibility and polymerization
time increase and become more bioacceptable [6].
In addition to its immediate hemostatic, ease ofapplication and
bacteriostatic properties, it is a good choice for closing surgical incisions.
One of the latest cyanoacrylate products is Iceberg-Glue,
which was manufactured in Italy several years ago and was put
up for internal use and has the CE mark. It differs from previous
products in being a comonomer rather than a simple monomer.
Iceberg Glue is composed of two monomers, n-butyl 2 cyanoacrylate
+ oca 2- octylcyanoacrylate. This monomer is manufactured
by the company. The addition of OCA contributes to the thermo-
diffusive polymerization of up to 45 degrees and also helps
to accelerate the polymerization process and reduce histotoxicity
[7], the use of Iceberg-GlueIt offers an additional benefit in
hemostasis of bleeding surfaces due to its coagulant action, as
it can be used as a dressing after dental extractions [8] and it can
also be used as a topical hemostatic after intraoral surgeries in
patients with hemorrhagic diseases [9]. Where cyanoacrylate has
been used in maxillofacial surgery [10] and oral surgery [11], such
as closing the incision after climax surgery [12] as well as closing
granular fistulas [13].
Setiya et al [14] et al. evaluated the advantages and disadvantages
of cyanoacrylate tissue adhesive after surgical extraction in sutureless
wound closure after surgical extraction of impacted lower
molars and found statistical significance in reducing pain, bleeding
and edema compared with the use of surgical suture In any
case, the healing was the same in both cases.
Setiya et al [14] et al. evaluated the advantages and disadvantages
of cyanoacrylate tissue adhesive after surgical extraction in sutureless
wound closure after surgical extraction of impacted lower
molars and found statistical significance in reducing pain, bleeding
and edema compared with the use of surgical suture However,
the recovery was the same in both cases.
Waite and cherala 2006 [15] have good results and fewer complications
after surgery of the lower third molars without sutures,
with less pain and faster recovery.
Materials and Methods
The sample consisted of 38 cases of surgical extraction of impacted
lower third molars in 19 patients from the Department
of Oral and Maxillofacial Surgery at the University of Damascus,
where the extraction was performed for each side separately with
an interval of two weeks. The first group (the control group)figure
[4], where the surgical extraction was performed, after which
the wound was closed by traditional suturing with silk thread 30/
(figure2),The second group (study group) figure [5], where the
surgical extraction was performed and after that the wound was
closed with the Iceberg-Glue tissue adhesive.(figure1)
The place where the extraction will take place, the wound will
be closed with the adhesive tape, and the place to be started was
chosen randomly. Patients were also selected from the auditors
of the Department of Oral and Maxillofacial Surgery at the Faculty
of Dentistry at Damascus University. The inclusion creteria
were: The presence of impacted lower third molars with medial
embolism of medium depth,The patient does not suffer from any
general diseases, The patient's age is between 19-30 years, Patients
are neither smokers nor alcoholic, Non-pregnant women,finally
the Patients who wanted to extract the lower third molars and
who met the study criteria were accepted.
Preoperative stage
After questioning the patient and making sure that he agrees with
the conditions of the research sample, the party to be started is
chosen, as well as the method used in the extraction, by lottery
using a coin.
Radiographic evaluation
Panoramic photo before surgery. (figure3)
Postoperative stage
The surgical work was performed on the right and left sides using
the same surgical technique and by the same surgeon with an interval
of two weeks. The difference was in the method of closing
the incision after extraction, where the incision was closed in the
control group by suturing with 3.0 silk thread, while the incision
was closed in the study group. By gluing a cyanoacrylate Iceberg-
Glue adhesive.
Surgical methods in group A
After performing Regional anesthesia of the inferior alveolar
nerve (IAN) and the buccal nerve, using 2% lidocaine solution
with adrenaline at a concentration of 1/80000. A crestal incision
was made with one vertical incision in the lateral of second molar
and full-thickness mucoperiosteal flap was raised to gain access to
the bone. After adequate bone removal, the tooth was removed by
appropriate elevators. The flap was repositioned and closed with
3-0 silk, and the sutures were removed after 7 days.
Surgical methods in group B
After performing Regional anesthesia of the inferior alveolar nerve (IAN) and the buccal nerve, using 2% lidocaine solution
with adrenaline at a concentration of 1/80000, a crestal incision
was made with one vertical incision in the lateral of second molar
and full-thickness mucoperiosteal flap was raised to gain access to
the bone. After adequate bone removal, the tooth was removed
by appropriate elevators. The flap was repositioned and closed
with iceberg-glue.
Postoperative recommendations
- The drug prescription was standardized for all patients, where
the patient is given an antibiotic augmentin 1 g twice daily for
five days, in addition to flam-k three times a day after food when
necessary.
- applying ice packs for 10 minutes and removing them for 10
minutes in the first six hours, avoiding pulling the cheek or placing
the tongue on the wound, using soft food in the first three days of
the operation, mouth rinses for two weeks, and the review After
two weeks.
Postoperative stage
Patients in both groups were followed in the same way, as follows:
1-Bleeding evaluation:
The degree of bleeding was monitored within 12 hours after surgery
by means of the VAS visual analog scale in four different
time periods (3 hours, 6 hours, 9 hours, and 12 hours after surgery)
before the operation. The patient, as this indicator consists
of four degrees, giving the numbers -4-3-2-1-0:
2- Pain evaluation:
The degree of postoperative pain was monitored by means of the
visual indicator VAS (figure 6) in three different time periods (the
first day, the third day, the seventh day) of the operation by the
patient, as this indicator consisted of 10 degrees giving numbers
from 0 to10.
Results
Studying the degree of bleeding according to the time period
studied:
Mann-Whitney U Test results:
P-value is smaller than the value 0.05 after three hours, after six
hours, and after nine hours, thatis, at the 95% confidence level,
there are statistically significant differences in the frequency of
the degree of bleeding after three hours, after six hours and after
nine hours between the group A and the group Bin the researchsample.
the degree of bleeding after three hours, after six hours,
and after nine hours in the group B was lower than in the group
A.
After twelve hours, P-value was much greater than the value 0.05,
that is, at the 95% confidence level, there were no statistically significant
differences in the frequency of the degree of bleeding
after twelve hours between the two groups.
Studying the effect of the method of closing the intra-oral incision
on the amount of pain visually according to the studied
period of time:
P- Value is much smaller than the value 0.05 on the first day and
the second day, that is, at the 95% confidence level, there are statistically
significant differences in the average values of the amount
of visual pain on the first day and on the third day between the
two groups. We conclude that the values of the amount of pain
visually on the first day and on the third day in the group B was
smaller than in the group A. On the seventh day, P-Value was
greater than the value 0.05, that is, at the 95% confidence level,
there were no statistically significant differences in the average
values of the amount of visual pain on the seventh day between
the two groups.
Figure 1. Iceberg-Glue tissue adhesive packaging.
Figure 2. The thread used.
Figure 3. Panoramic Photo.
Figure 4. Method of group (A).
Figure 5. Method of group (B).
Figure 6. Visual Indicator of Pain.
Table 1. The visual indicator of hemorrhage.
Table 2. Shows the results of the Mann-Whitney U test to study the significance of the differences in the frequency of the degree of bleeding between the group of intraoral incision closure using Iceberg-Glue tissue tape and the group of incision closure of intraoral incision using traditional suture in the research sample, according to the time period studied.
Table 3. Shows the results of the Student's T-test for independent samples to study the significance of differences in the average values of visual pain between the group of intraoral incision closure using Iceberg-Glue and the group of intraoral incision closure with conventional suture in the research sample, according to the time period thoughtful.
Discussion
N-butyl-2-cyanoacrylate is a biocompatible tissue adhesive that has favorable properties, such as fine flow and rapid hardening,
and has strong bonding properties and strength to hold the edges
of the tissue together. The valence bond and van der Waals force
help achieve tissue adhesion. After n-butyl-2-cyanoacrylate is applied,
it forms a strong bond through the polymerization reaction
with exothermic water, tissue moisture or blood. Cyanoacrylate is
exothermic substances released through the polymerization reaction
and they are also bacteriostatic. The wound site closed with nbutyl-
2-cyanoacrylate showed less postoperative pain than those
closed by other methods finally, cyanoacrylates are good hemostatic
agents [3]. One of the hypotheses states that the formation
of a micro-layer through the organic salt ester due to mechanical
blockade, which slows the blood flow and provides a surfactant
to stimulate the coagulation cascade. Evidence has shown that the
nano-layer forms a porous mass which is invaded by the blood
and thus there will be subsequent clotting through the pores of
the adhesive [5]. Cyanoacrylate offers various advantages such
as fast and effective hemostasis, ease of application, bactericidal
properties, and fast tissue adhesion. Tough and soft, maximum
bonding strength and waterproof housing. They also have a wide
range of applications such as: organ repair, vessels, mucosal graft-
Dermatology: Closing lacerations and fissures: Treating wounds
after extractions: Repairing mandibular fractures [5].
In order to maximize the adhesion and minimize patient discomfort,
surgeons and physicians have suggested the use of tissue
tapes as an alternative to sutures for closing wounds. Ice-berg glue
is one of the most commonly used tissue tapes. Several gelatin
derivatives have been investigated for their use as tissue adhesives
in surgery, such as epoxide, polyurethane, and resorcin. Iceberggluehas
gained wider acceptability and has achieved better results
than gelatin. In the past 50 years, polymeric adhesives have been
used in medical and dental practices. One of the drawbacks of
polymers is that they are incompatible with tissues and can produce
a severe inflammatory reaction [5] by the early 1970s; cyanoacrylate
gum was used to repair bones. In the 1996 Vietnam
War, cyanoacrylate was used as a hemostatic agent for wounded
soldiers. Adhesives such as iceberg-gluenot only require less time
to close the wound compared to that required by traditional methods,
but also reduce the spread of infection and improve the aesthetics.
Since iceberg-glueglue has superior properties compared to those
of other cyanoacrylates, it may be better for wound healing and
therefore we believe that there is a need for clinical evaluation of
its role in intraoral wound closure.
We agreed with the study of Setiya et al with regard to the bleeding
index, where they studied the evaluation of phagocytosis, the
advantages and disadvantages of cyanoacrylate tissue adhesive,
through wound closure after surgical extraction of the impacted
lower molars. They were studied on 50 patients with impacted
lower molars. The statistical analysis showed that the use of Cyanoacrylate
wound closure tape causes less pain after surgery, as
well as bleeding and swelling compared to the use of sutures, and
therefore there was better hemostasis than the control side, but
the healing was the same in both groups [14].
We also agreed with the study of those who obtained good results,
better hemostasis and fewer complications after surgical
extraction of impacted lower molars in the study side in which
surgical tape was used compared with the control side in which
surgical sutures were used [15].
We also agreed with the study of Surindar et al, who obtained
effective and statistically significant results regarding hemostasis
index after minor intraoral surgeries and proved that cyanoacrylate
adhesive acts on instant polymerization upon adhesion with
these oral tissues [20].
In the same way, Kulkarni et al noted the use of cyanoacrylate
after periodontal surgery [3].
We also agreed with the study of Milton et al, who observed that
there is immediate hemostasis during treatment of the bleeding
pulp [16].
We also agreed with fuad and maged study, they concluded the hemostatic
effect of cyanoacrylate in warfarin-treated patients who
underwent oral surgery [9].
We also agreed with the study of ghoreishian et al that showed
that the hemostatic effect of cyanoacrylate was significantly better
compared to conventional suture on the first and second day
after surgery [18].
The same result was noted by ajit et al [15].
Also in our study, significant and significant results were obtained
for the advantage of iceberg glue in hemostasis compared to the
suture side, where it was found that the degree of bleeding after
3 hours, 6 hours, 9 hours was lower than in the tissue adhesive
group where (p = 0.0104; p = 0.000; p = 0.003), respectively,
where p-value < 0.05, while there were no significant differences
after 12 hours, where (p = 0.152), and p-value > 0.05 compared
with the tailoring party.
Also in our study, we obtained significant and noticeable results
for the preference of iceberg glue in the intensity of pain compared
to the suture side. < 0.05 while there was no significant
difference on the seventh d9ay ( p = 0.053) and p-value > 0.05
compared with the suture side.
Regarding the pain metric, we agree with the researcher’s pasqualini
and cocero [2] who found that the pain was less severe with
secondary healing than with primary healing after surgical extraction
of impacted molars.
The same applies to the study of the researcher Ellis [17]) who
noticed that the pain was less in the tissue adhesive group than
in the suture group, in contrast to the result obtained by the researcher
Ghoreishian et al [18] which there were no fundamental
differences pain between the two groups in his study.
Researcher kulkarni [3] found that the pain was less after using
tissue adhesives after periodontal surgeries.
Researcher Boaz et al [19] concluded that tissue adhesive causes
less pain than suture, while researcher Ajit et al [14] saw significant
differences in pain intensity in both groups after three days
of surgery, and this is what it may return due to the lack of tissue
infections after this period.
Also in the study snehasetiya et al [14] saw a significant decrease in pain intensity on the first, second and third postoperative days
in favor of the tissue adhesive group.
Conclusion
Iceberg glue has a significant and effective effect on hemostasis
and pain after surgical extraction of impacted lower molars compared
with traditional suture with 3/0 silk thread.
Acknowledgement
This research was funded by Damascus University.
References
-
[1]. Hupp JR, Tucker MR, Ellis E. Contemporary oral and maxillofacial surgery.
2008.
[2]. Pasqualini D, Cocero N, Castella A, Mela L, Bracco P. Primary and secondary closure of the surgical wound after removal of impacted mandibular third molars: a comparative study. Int J Oral Maxillofac Surg. 2005 Jan 1;34(1):52-7.
[3]. Kulkarni S, Dodwad V, Chava V. Healing of periodontal flaps when closed with silk sutures and N-butyl cyanoacrylate: a clinical and histological study. Indian J Dent Res. 2007 Apr-Jun;18(2):72-7.Pubmed PMID: 17502712.
[4]. Saltz, R. and D.M. Toriumi.Tissue glues in cosmetic surgery.CRC PressI Llc. 2004.
[5]. Kumar VR, Rai AB, Priyayadav. Comparative evaluation of n-butyl cyanoacrylate and silk sutures in intra oral wound closure-A clinical study. J. Adv. Oral Res. 2010 Oct;1(1):37-42.
[6]. Leggat PA, Smith DR, Kedjarune U. Surgical applications of cyanoacrylate adhesives: a review of toxicity. ANZ J. Surg. 2007 Apr;77(4):209-13.
[7]. Leonardi M, Barbara C, Simonetti L, Giardino R, Aldini NN, Fini M, et al. Glubran 2: a new acrylic glue for neuroradiological endovascular use. Experimental study on animals. Interv Neuroradiol. 2002 Sep 30;8(3):245-50. Pubmed PMID: 20594482.
[8]. Dogon IL, Heeley JD. A study on the use of fluoroalkyl cyanoacrylate adhesive as a hemostatic agent and dressing after exodontia. Oral Surg Oral Med Oral Pathol. 1978 Apr;45(4):503-15.Pubmed PMID: 417279.
[9]. Al-Belasy FA, Amer MZ. Hemostatic effect of n-butyl-2-cyanoacrylate (histoacryl) glue in warfarin-treated patients undergoing oral surgery. J Oral Maxillofac Surg. 2003 Dec;61(12):1405-9.Pubmed PMID: 14663804.
[10]. Soni A, Narula R, Kumar A, Parmar M, Sahore M, Chandel M. Comparing cyanoacrylate tissue adhesive and conventional subcuticular skin sutures for maxillofacial incisions--a prospective randomized trial considering closure time, wound morbidity, and cosmetic outcome. J Oral Maxillofac Surg. 2013 Dec;71(12):2152.e1-8.Pubmed PMID: 24237777.
[11]. Inal S, Yilmaz N, Nisbet C, Güvenç T. Biochemical and histopathological findings of N-butyl-2-cyanoacrylate in oral surgery: an experimental study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Dec;102(6):e14-7.Pubmed PMID: 17138158.
[12]. Kazzi MG, Silverberg M. Pediatric tongue laceration repair using 2-octyl cyanoacrylate (dermabond(®)). J Emerg Med. 2013 Dec;45(6):846-8.Pubmed PMID: 23827167.
[13]. Buric N. Use of N-butyl cyanoacrylate with metacryloxisulfolane (glubran 2) surgical glue for flapless closure of oroantral communication. Implant Dent. 2013 Jun;22(3):238-43.Pubmed PMID: 23442603.
[14]. Setiya S, Halli R, Shah A, Chhabaria G, Singh T. Comparative evaluation of efficacy of tissue glue and sutures after surgical removal of impacted mandibular third molars–A prospective controlled clinical study. J Oral Maxillofac Surg Med Pathol. 2015 Mar 1;27(2):183-8.
[15]. Waite PD, Cherala S. Surgical outcomes for suture-less surgery in 366 impacted third molar patients. J Oral Maxillofac Surg. 2006 Apr;64(4):669-73. Pubmed PMID: 16546647.
[16]. Berkman MD, Cucolo FA, Levin MP, Brunelle LJ. Pulpal response to isobutyl cyanoacrylate in human teeth. J Am Dent Assoc. 1971 Jul;83(1):140-5. Pubmed PMID: 5281165.
[17]. Ellis DA. Comparison of skill suture and N–Butlyl–2–cyanoacrylate on the healing of skin wound. Aust Dent J. 1995 Feb;40(1):43-5.
[18]. Ghoreishian M, Gheisari R, Fayazi M. Tissue adhesive and suturing for closure of the surgical wound after removal of impacted mandibular third molars: a comparative study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jul;108(1):e14-6.Pubmed PMID: 19464207.
[19]. Mizrahi B, Weldon C, Kohane DS. Tissue adhesives as active implants. In- Active implants and scaffolds for tissue regeneration. 2010: 39-56.
[20]. Bhaskar, S.N. and J. Frisch. Use of cyanoacrylate adhesives in dentistry.J Am Dent Assoc.1968. 77(4): 831-837.
