Abstract
The aim of this randomized controlled trial was to assess the effectiveness of fibrin sealants in achieving haemostasis and wound closure following mandibular third molar extraction, in comparison with conventional suturing. Thirty patients with bilateral mandibular third molar impactions were recruited for the study. Using a split-mouth study design, wound closure following extraction was done using fibrin sealant on the study side and suturing on the control side. Sample allocation was done by simple randomization. The primary outcome measures were (1) the time taken to achieve wound closure and haemostasis and (2) postoperative mouth opening, pain, and swelling. Data analysis involved descriptive statistics and paired t -tests ( P < 0.05). IBM SPSS software (v.20.0) was used for the data analysis. The study group demonstrated a statistically significant reduction in duration to achieve haemostasis (1.2 vs. 251.9 s; P < 0.001) and wound closure (152.8 vs. 328.8 s; P < 0.001) in comparison with the control group. The study group also exhibited significantly reduced pain scores (2.0 vs. 3.5; P < 0.001) and increased post-surgical mouth opening ( P < 0.001). No adverse effects of fibrin sealant were observed. In conclusion, fibrin sealant is a superior intraoral wound closure and haemostatic agent and a worthy alternative to suturing.
The achievement of haemostasis and good mechanical closure of the wound are of immense importance in the field of surgery. Sutures have remained the mainstay for wound and haemorrhage management for centuries, despite their relative demerits. Novel materials including staples, tapes, and tissue adhesives have been utilized as potential substitutes for sutures to achieve optimal surgical outcomes. Of these resources, tissue adhesives developed in the twentieth century, such as fibrin sealants, cyanoacrylates, bovine collagen and thrombin, polyethylene glycol polymer, and gluteraldehyde, have a unique place in the management of wounds.
Amongst all the other tissue adhesives, fibrin sealants, which mimic natural fibrin mesh, have garnered much attention. They have been in use since the early 1900s. The first reported use as a haemostatic agent was by Bergel in 1909. Since then, there have been many publications describing the role of fibrin glue as a haemostatic agent, tissue adhesive, and anastomotic agent for nerve and skin grafting.
Fibrin sealants have diverse clinical applications. They have been specifically indicated for haemostasis in cardiac, liver, and splenic procedures and for sealing colonic anastomoses. They are used widely in thoracic procedures for the management of bronchopleural fistulae. Fibrin sealants have also shown significant utility in the fields of microsurgery, burns, and ophthalmic and gynaecological surgery as a haemostatic agent, adhesive, and tissue approximating agent.
Mention of fibrin sealants in the oral and maxillofacial literature is limited, with only a few reports of its application as an ‘adjunct’ in vestibuloplasty, aesthetic facial surgery, head and neck reconstruction, and periodontal procedures. The role of fibrin sealants in routine dentoalveolar and intraoral surgical procedures needs to be explored and assessed, for better clinical application. These sealants may also be a valuable tool where there are special indications, such as for haemophiliacs and patients on anticoagulants, for whom a greater degree of haemorrhage control is required.
This clinical trial was designed to study the efficacy of fibrin sealant as an intraoral wound closure material and to compare it with conventional suturing, and at the same time, to evaluate patient response parameters.
Patients and methods
Study design
The study was designed as a randomized controlled clinical trial comparing fibrin sealant with conventional suturing using 3–0 black silk, for a sample of 30 patients undergoing bilateral extraction of mandibular third molars. The necessary approval for the study was obtained from the institutional review board and the study was performed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) statement. The study was done using the ‘split-mouth method’, where one side was assigned for fibrin sealant (study group) and the contralateral side for conventional suturing (control group) ( Fig. 1 ). Thus each patient was his/her own control, to negate inter-patient bias. The second side surgery was performed 3 weeks after the first side. This ensured complete healing of the surgical wound and eliminated an overlap of symptoms as well as a distortion of the results while calculating pain, swelling, and mouth opening. The patient pool was sequentially numbered 1–30. Lots were drawn, one for each patient, from sealed envelopes that contained combinations of the agent (fibrin sealant/suturing) and the side to be operated (right/left).
Patient selection
Thirty consecutive patients requiring surgical removal of bilateral mandibular third molars, with similar grades of difficulty, were recruited for this clinical trial. Patients were provided with an explanation of the study and gave consent for the procedure and clinical study.
The following inclusion criteria were applied: (1) ASA 1 (American Society of Anesthesiology) patient with no systemic diseases or conditions; (2) patient requiring surgical removal of bilaterally impacted mandibular third molars; (3) bilateral impactions with a relatively similar classification and degree of difficulty, based on the Pell and Gregory system ( Fig. 2 ); (4) patient agreement to the surgical procedure and clinical trial, providing informed consent.
The following exclusion criteria were applied: (1) presence of systemic diseases; (2) presence of bleeding disorders; (3) patients on anti-platelet or anticoagulant therapy; (4) pregnant or nursing mothers; (5) patients with a known history of allergy to lignocaine; (6) patient not consenting to the procedure or study.
Surgical procedure
All patients underwent surgical removal of the impacted teeth under local anaesthesia. A single operating surgeon performed all procedures. The patients underwent surgery on only one side at a given appointment, with the second side being operated on after a period of 3 weeks. Preoperatively, the maximum mouth opening (maximum inter-incisal opening (MIO) in millimetres) was noted for each patient. The surgical procedure was standardized as follows: (1) Site preparation with 5% povidone–iodine solution. (2) Local anaesthesia administered by inferior alveolar and buccal nerve blocks, using 2% lignocaine hydrochloride with 1:80,000 adrenaline bitartrate. (3) Conventional Ward’s incision to raise a mucoperiosteal flap. (4) Bone removal with a surgical drill under cold saline irrigation, for surgical exposure and delivery of the tooth.
Haemostasis and wound closure was performed with two 3–0 braided black silk interrupted sutures for the control group ( Fig. 3 ) and fibrin sealant (Baxter Healthcare, Vienna, Austria) for the study group ( Fig. 4 ). The fibrin sealant was prepared in accordance with the manufacturer’s instructions by reconstitution of the four components (fibrinolysis inhibitor solution, sealer protein, thrombin, and calcium chloride) and was applied with a ‘Duploject’ (double syringe device). The prepared sealant may be stored for a period of 4 h.
Parameters for outcome assessment
The time taken for wound closure (in seconds) was noted in both groups. The bleeding time (in seconds) after wound closure was noted. The time at which bleeding stopped completely was noted. Patients were given postoperative instructions and were recalled for review on days 1 and 7 postoperative, to assess the MIO, post-surgical pain, and swelling.
Review protocol
The patient was checked for pain on day 1 postoperative and for MIO and swelling on days 1 and 7 postoperative.
A numerical pain rating scale was used to assess pain. The patient was asked to rate the severity of pain from 0 to 10, where 0 indicated no pain at all, 5 indicated moderate pain, and 10 indicated the worst possible pain.
Facial swelling was measured (in millimetres) and recorded. The fixed reference points used to measure this were the following : A, the most posterior point on the tragus; B, the lateral canthus of the eye; C, the most lateral point on the corner of the mouth; D, the soft tissue pogonion, which is the most prominent point at the midline on the chin; E, the most inferior point on the angle of the mandible ( Fig. 5 ). The three reference lines used were AC, AD, and BE ( Fig. 5 ).
A baseline measurement was made just before surgery and similar measurements were done on days 1 and 7 post-surgery. The linear measurements AC, AD, and BE were measured using a flexible measuring tape. The degree of swelling was calculated as the difference between the averages of the preoperative and postoperative values, i.e. postoperative (AC + AD + BE) − preoperative (AC + AD + BE).
Statistical tests
Normality test results (Kolmogorov–Smirnov test and Shapiro–Wilk test) showed that the samples followed a normal distribution. Therefore parametric tests were used to analyze the data. As this was a split-mouth study, the paired t -test was used to compare the mean values between the control and experimental groups. The paired t -test was also applied for comparisons between time points. The level of significance was fixed as α = 0.05 (two-tailed). IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA) was used for the data analysis.
Results
Compared to the control group, the study group showed a statistically significant reduction in the durations for achieving local haemostasis and wound closure ( Table 1 ). The mean time taken for approximation of the wound with 3–0 silk sutures was found to be 328.8 s, as compared to a mean of 152.8 s with the fibrin sealant. The mean time for achieving haemostasis in the study group was 200 times faster than that in the control group (1.2 s vs. 251.9 s).
| Variable | Study group | Control group | P -value |
|---|---|---|---|
| Time to haemostasis, s | 1.2 ± 0.4 | 251.9 ± 67.9 | <0.001 |
| Time to wound closure, s | 152.8 ± 15.8 | 328.8 ± 40.0 | <0.001 |
| MIO on day 1 postoperative, mm | 35.8 ± 2.5 | 23.9 ± 2.6 | <0.001 |
| MIO on day 7 postoperative, mm | 41.3 ± 2.3 | 37.8 ± 2.2 | <0.001 |
| Postoperative pain score | 2.0 ± 1.5 | 3.5 ± 1.6 | <0.001 |
| Swelling on day 1 postoperative, mm | 6.8 ± 1.2 | 6.4 ± 1.3 | 0.168 |
| Swelling on day 7 postoperative, mm | 1.1 ± 0.5 | 1.0 ± 0.7 | 0.422 |
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