A comparative study on the effectiveness of Iso–amyl cyanoacrylate tissue adhesive to silk sutures in the closure of periodontal flap:

A split-mouth study

 

Dr. Dipika¹, Dr. Sankari M¹, Dr. Gopal Nambi²

¹Dept of Periodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences,

Chennai, Tamilnadu, India.

²Dept of Physical Therapy, College of Applied Medical Sciences, Prince Sattam Bin Abdul Aziz University,

Al-Kharj, Saudia Arabia.

 

ABSTRACT:

Background: Many factors contribute to uneventful and healthy postoperative healing. Hence the primary union between flap margins during the closure of periodontal flap, post-surgery is of utmost importance. Isoamyl cyanoacrylate is a tissue adhesive, which can be used for the closure of elevated flaps to overcome the problems associated with conventional suture material like silk. Aim: This study aims to compare healing after periodontal flap surgery using isoamyl cyanoacrylate tissue adhesive and silk sutures. Materials and Methods: The split-mouth study was carried out on twenty patients who needed flap surgery for pocket therapy. The outcome measures measured were plaque index (PI), colony forming units (CFU), C-reactive protein levels pre and 1 week after flap surgery, wound healing index and VAS score for discomfort, aesthetics and ease of maintenance 1 week post-op. Paired t‑test was used for intragroup post procedure improvement in each parameter, and independent sample t‑test was used for intergroup comparison. Results: the cyanoacrylate group showed significant improvement in Plaque Index, colony forming units, C-reactive protein levels and VAS score for discomfort, aesthetics and ease of maintenance. Conclusion: Iso-amyl cyanoacrylate tissue adhesive is an effective procedure in periodontal flap surgery. Clinical Significance: Iso-amyl effectively reduces chair side time due to ease of application and shows better patient compliance due to minimal discomfort and better aesthetics when compared to conventional suture materials.

 

 

 

INTRODUCTION:

Periodontal flap surgery is a routinely employed procedure in the management of moderate to deep periodontal pocket. Intimate adaptation of the flap to the prepared root surface during the immediate post-surgical phase is essential for the reestablishment of the dentogingival unit.¹

 

Sutures are commonly used to hold the flap in place. Materials like silk, nylon, catgut and polyglycolic polylactic acid derivatives are routine used suture material, with silk being the most commonly used material.^2,3 Tissue trauma due to needle penetration, scar formation, secondary infection, need to sterilize, second visit for suture removal are some of the shortcomings of the conventional suture material.⁴ In addition, “wicking” of silk suture makes the surgical site prone to secondary infection.⁵ Staphylococcus aures is the organism commonly associated with wound infection, some of the other organisms impliated are: Pseudomonas aeruginosa, Enterobacteriaceae, Enterococcus spp. And opportunistic fungi like candida.⁶ To overcome these limitations of conventional sutures the search for newer materials was done, cyanoacrylate is one such material.

Coover was the first to synthesize cyanoacrylate in 1959. The chemical structure of cyanoacrylate is H 2C = C (CN) COOR, where R- is an alkyl group ranging from methyl to decyl.^7,8 The lower homologs were cytotoxic and its use in medicine was discontinued, however, higher homologs, starting from butyl are considered safe.⁹ Cyanoacrylate has high tensile strength, is biocompatible and has anti-bacterial properties and is widely used in gastrointestinal surgeries, ophthalmic surgeries.¹⁰

 

The aim of this study was to compare the effectiveness of iso-amyl cyanoacrylate tissue adhesive to conventional silk suture base on clinical, microbiological parameters, CRP levels, early healing index (EHI) and patient related factors of pain/ discomfort, ease of maintenance and aesthetics after periodontal flap surgery.

 

MATERIAL AND METHODS:

This comparative, split-mouth, single-blinded study (assessor was blinded to the study) included 20 patients with persistent moderate to deep periodontal pockets (PPD > 5mm) in at least 2 quadrants after 3 weeks of scaling and root planning. The protocol was approved by the institutional review committee for human subjects (SRB/MDS/PERIO/18-19/0024) and the study was conducted in accordance with the Helsinki Declaration of 1975, as revised in 2013. The sample size was calculated based on post-hoc analysis of similar studies on cyanoacrylate adhesives, with the power of the study adjusted to 80%. An informed consent was obtained from the patients. (fig-1 depicts COSORT flow chart of the study).

 

Fig-1: Study flow chart

The study subjects were aged between 30-50 years. The inclusion criteria were persistent periodontal pocket 5 mm or more bilaterally, 3 weeks after phase 1 periodontal therapy, with radiographic evidence of horizontal bone loss. The exclusion criteria were known systemic diseases and/or drug therapy which may interfere with wound healing, drug allergies to any of medications used in the study, habit of smoking, tobacco chewing, or any other habit that might influence the disease or the treatment outcome and pregnant or lactating mother and patients with angular bony defects which would require grafting procedure and may interfere with the outcome and subjects not willing to participate were excluded.

 

Three weeks following phase 1 therapy; which consisted of scaling and root planning, the baseline measurements of probing pocket depth and plaque index was recorded and subgingival plaque sample and GCF was collected for measuring CFU and CRP levels. All the surgical procedures were performed under local anesthesia (2% lignocaine with epinephrine 1:100,000) by a single trained surgeon. A sulcular incision was made at the site were surgery was planned. A conventional undisplaced mucoperiosteal flap was raised on the labial/buccal and lingual/palatal aspects of the involved teeth. Thorough debridement was carried by removing local irritants and diseased granulation tissue using curettes and ultrasonic instruments (fig-2). After debridement, the flap was trimmed and repositioned to accomplish as much complete interproximal closure as possible. The quadrants treated were randomly assigned by flipping a coin to two Groups, namely: Group A: iso-amyl cyanoacrylate tissue adhesive (Amcrylate^® 0.25 ml as shown in fig-3) and Group B: silk sutures (Ethicon Mersilk #3-0 Black Braided Suture).

 

 

Fig-2: flap elevation

 

Fig-3 Iso-amyl cyanoacrylate tissue adhesive

 

The cyanoacrylate adhesive was applied to the test site as instructed by the manufacturer (fig-4). In the quadrants where silk sutures were placed, simple interrupted suture/ direct loop was the suture technique of choice. No periodontal dressing was placed. Postsurgical instructions were given. Antibiotics (Amoxicillin 500mg three times a day) and analgesics (combination of Aceclofenac 100mg and Paracetamol 325mg) were prescribed for 5 days. Patient was instructed not to brush his/her teeth at the surgical site for 1 week. Chlorhexidine mouthwash 0.12% was prescribed, to be used twice a day for 2 weeks. Sutures were removed after 1 week and post-operative parameters were measured (fig-5). The healing in all cases was uneventful; however, loss of a single suture was seen in 2 cases in the silk suture group.

 

Fig-4 Application of Iso-amyl cyanoacrylate

 

Fig-5 One week post-operative

 

Healing of flap was assessed after 1 week using wound healing index (WHI by Huang et al)¹¹ and a subjective assessment of pain/discomfort, aesthetics and ease of maintenance was done using the VAS scores ranging from 0-10 (where 10 = maximum discomfort/lack of aesthetics/difficult to maintain and 0 = no discomfort/ aesthetic/easy to maintain). The data collected was analyzed using SPSS 16 software.

 

RESULTS:

The data was analyzed using t-test and it was found that the baseline values of PI, colony forming units and CRP levels between the groups did not show any statistical significance implying that the sample was homogeneous. The post - operative value for same was statistically significant between the groups (p < 0.05) and there was a statistical significance (p < 0.05) between the pre and post values of group A (cyanoacrylate group). The healing index, assessed 1week post – operative showed a statistical significance (p < 0.05) between the groups (table 1). The patient related parameters: post - operative discomfort/pain, ease of maintenance and aesthetics were measured using the visual analog scale (VAS), which showed a statistical significance between the two groups (fig 6).

 

Fig-6 Graph showing difference between the silk and cyanoacrylate groups.

 

Table 1 Pre and post values of CRP, CFU, Plaque index and Healing Index in Cyanoacrylate and Silk Group.

Variables	CRP		CFU		Plaque Index		H. Index
	Baseline	Post	Baseline	Post	Baseline	Post	Post
Cyanoacrylate	1.40 ± 0.32	0.44 ± 0.23	13.5 ± 0.5	11± 0.5	1.51 ± 0.10	1.43 ± 0.19	1.8 ± 0.55
Silk	1.41 ± 0.34	0.92 ± 0.36	13.4 ± 0.6	18 ± 0.8	1.57 ± 0.18	1.95 ± 0.29	2.3 ± 0.67
P – value	0.9242	0.0001	0.5703	0.0001	0.2004	0.0001	0.0139

 

DISCUSSION:

The present study was conducted to compare the effectiveness of iso-amyl cyanoacrylate tissue adhesive to silk sutures when used to approximate the flap after periodontal surgery. The post-surgical healing 1week post-operative was assessed using wound healing index (Huang et al), PI, CRP levels in GCF, CFU at baseline and 1week post - operative. Subjective assessment of pain/discomfort, aesthetics and ease of maintenance was done using 10 point VAS scale. The baseline values of plaque index, CFU and CRP levels in GCF between the groups was not significant suggestive of a homogenous sample.

 

There is a mean reduction post-operative values in the PI scores in the cyanoacrylate group which was statistically significant whereas the silk group showed an increase in PI scores, this could be attributed to the fact that the patient was refraining from mechanical oral hygiene procedures and that the silk suture collected plaque due to its multi-filamentous nature.⁵

 

Similarly, a mean reduction in the microbiological parameter i.e. CFU was seen in the cyanoacrylate group which is attributed to the ease with which oral hygiene was maintained and antibacterial property of cyanoacrylate adhesive.^12,13 This finding is in conjunction with the findings of Kulkarni et al.¹⁴ However, there was an increase in the mean number of CFU in the silk group for which the lack of mechanical oral hygiene measures which led to plaque accumulation could be held responsible.¹⁵

 

C-reactive protein (CRP) is an acute phase reactant which represents an early, non-specific reaction to a variety of injury.¹⁶ Normal level of CRP is 1.0mg/L, CRP levels are elevated during inflammatory conditions, cardiovascular diseases and infections.¹⁷ Levels of CRP are elevated in gingivitis and periodontitis when compared to healthy individuals and reduce following therapy, our study is in agreement with the same.¹⁸ The more significant reduction in the CRP levels in the cyanoacrylate group can be attributed to the lower plaque accumulation were as the silk suture showed tendency for plaque accumulation.

 

The VAS scores showed significant difference between the two groups in terms of post-operative discomfort, aesthetics and ease of maintenance, these were in conjunction with the findings of similar studies.^19,20

 

CONCLUSION:

Based on our study results we conclude that iso-amyl cyanoacrylate tissue adhesive is an effective treatment in periodontal flap surgery.

 

CLINICAL SIGNIFICANCE:

Iso-amyl effectively reduces chair side time due to ease of application and shows better patient compliance due to minimal discomfort and better aesthetics when compared to conventional suture materials.

 

CONFLICT OF INTEREST:

None.

 

ACKNOWLEDGEMENT:

The authors are thankful to all the participants and contributors of this study and the publication was supported by Deanship of Scientific Research, Prince Sattam Bin Abdul Aziz University.

 

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Received on 09.09.2019           Modified on 13.11.2019

Accepted on 11.01.2020         © RJPT All right reserved