) AIM AND OBJECTIVES OF THE STUDY AIM To compare and evaluate the efficacy of cyanoacrylate tissue adhesive over silk suture for the closure of wound after surgical removal of impacted mandibular third molars. OBJECTIVES To evaluate the closure time, pain, bleeding, and wound healingfollowing placement of 3-0 silk suture for the closure of surgical wound after impacted third molar impaction. To evaluate the closure time, pain, bleeding, and wound healing following placement of cyanoacrylate tissue adhesive for the closure of surgical wound after third molar impaction. To compare the closure time,pain,bleeding,and woundhealing between 3-0 silk suture and cyanoacrylate tissue adhesive. 5) STUDY DESIGN Prospective interventional study 6) MATERIALS AND METHODS 6.1) MATERIALS Disposable gloves Local anesthesia Mouth mask Mouth mirror Tweezers Cotton and gauze Kidney tray B P blade Dials Periosteal elevator Kay Austin retractor Cupland elevator Apex elevator Bone cutting burs Micromotor Suction tip Mandibular third molar forceps 3-0 silk suture Needle holder Scissors Cyanoacrylate tissue adhesive 6.2) METHODOLOGY The patients coming to the OPD of the Department of Oral and Maxillofacial Surgery, Yenepoya Dental College, who are diagnosed with mesioangularimpacted submergedmandibular third molar, classified as class II position B, according to Pell and Gregory’s classification, and indicated for surgical removal will be included in this study. A detailed case history will be taken with clinical examination. Pretreatment OPGwill be obtained. The inferior alveolar, long buccal, and lingual nerves will be anesthetized with 2% lidocaine hydrochloride with epinephrine 1:80000 using conventional block technique. The buccal approach with Ward’s incision flap is used. The flap will bereflected and osteotomy will be performed by buccal guttering technique with a number 702 or 703straight fissure bur under copious irrigation with sterile 0.9% normal saline solution. The tooth will be sectioned (if required) with astraight fissure bur, then all parts of the tooth will be removed. Once the extraction is completed, the socket will be curetted and sharp bony edges will be rounded up with bone file along with copious irrigation consisting of about 50ml of 0.9% normal saline. v CLOSURE METHOD Group A: After achieving hemostasis, the flap will be repositioned and closed with a 3-0 silk suture using an interrupted suturing technique. Three sutures will be placed; one at the mesial relieving incision, the second-placed distal to the second molar, and the third-placed distal to the extraction socket to achieve healing by primary intention. Group B: After achieving hemostasis, the flap will be repositioned and closed by usingcyanoacrylate glue [Mervilyte(Iso Amyl 2-Cyanoacrylate), dispensed in ampules of 0.25ml]. The wound edges will be adapted together with a tissue holding forceps, then 1st layer of cyanoacrylate glue will be applied by dropping the liquid from a syringe and needle (provided by the manufacturer) along the whole incision lines (distal incision, mesial relieving incision, and flap over the socket), followed by another layer after 20 seconds. The closure will be done to achieve healing by primary intention. To prevent inadvertent oral exposure to cyanoacrylate, the flap will be isolated from the adjacent oral mucosa with sterile gauze roll. After the extraction, subjects will be informed to eat a soft diet and avoid using the operated side for mastication within the first 24 hours. Normal oral hygiene including warm saline mouth rinse and tooth brushing to be started a day after surgery. All subjects will be given similar preoperative medications of IV Dexamethasone 4mg stat and postoperative medications, which are commenced immediately after the procedure, Cap. Amoxicillin 500 mg 8hrly for 5 days, Tab. metronidazole 400mg 8hrly for 3 days and Tab. Diclofenac Sodium 50 mg 8hrly for 3 days. The patients will be followed up on 1st, 3rd, and7thpost-operative days to evaluate the efficacy of the procedure. After tooth removal patients are instructed to · Do not rinse your mouth for 4 hours. · Do not remove the cotton / gauze placed over the wound foe at least one hour. Bite down firmly on the cotton for half an hour. · Do not place your tongue or finger over the wound area. · Eat only soft food for the rest of the day. · Do not take hot drinks, avoid alcohol and smoking for the rest of the day. · Do not chew on the affected side for at least 2 days. · Use prescribed medicines regularly. · If the tooth socket continues to bleed even after 2 hours place a piece of gauze or cotton over the socket and close the mouth firmly for 15-30 minutes. If still continues seek dental or medical advice CLINICAL ASSESSMENT: The following parameters are taken into consideration for the assessment of the procedure: Closure Time: will be evaluated by recording the time via stopwatch from the start of the placement till the completion of the procedure. In group A, the closure time is regarded as the time between the placement of the first suture and the final suture. In group B, the closure time is regarded as the time between the placement of the first drop of Mervilyte and the final drop. Post-operative pain: will be evaluated by a 10 level Visual Analogue Scale (VAS) with the patient placing a mark on the scale to indicate an intensity range from no pain ‘0’ to severe/unbearable pain ‘10’. This will be recorded in patients with silk suture and cyanoacrylate tissue adhesive on the1st, 3rd, and 7th postoperative day. Bleeding:Will be evaluated by 4 level Visual Analog Scale (VAS). This will be recorded in patients with silk suture and cyanoacrylate tissue adhesive on the 1st and 3rd, postoperative day. | GRADE | TYPE OF BLEEDING | DESCRIPTION | | 0 | No bleeding | The patient does not detect any blood in Saliva | | 1 | Oozing | The patient detects slight blood but it is not very noticeable | | 2 | Accidental bleeding | The patient has low bleeding sometimes | | 3 | Continuous bleeding | The patient has low bleeding often | | 4 | Massive Bleeding | Continues high bleeding | Wound healing; Will be evaluated by 3 score10. This will be recorded in patients with silk suture and cyanoacrylate tissue adhesive on the 1st, 3rd,and 7th postoperative day. | SCORE | DESCRIPTION | | 1 | Uneventful wound healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence. | | 2 | Uneventful wound healing with slight gingival edema, erythema, patient discomfort or flap dehiscence, but no suppuration | | 3 | Poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence or any suppuration | 6.3)STUDY SETTING The proposed study will be a comparative study with the following procedural steps Obtaining approval for the study protocol from the institutional ethics committee, Yenepoya University, and obtaining official permission to conduct the study from the institutional ethics committee, Yenepoya University, Hospital Authority. 6.4) SOURCE OF DATA The study will be conducted on patients visiting in the DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, YENEPOYA DENTALCOLLEGE,Mangalore, Karnataka. SAMPLING TECHNIQUE Simple random sampling 6.5)SAMPLE SIZE 5% level of significance and 80% power and effect size of 0.5, the sample size will be 7in each group. Group A: Closure with 3-0 silk suture for sample size 7 Group B: Closure with cyanoacrylate tissue adhesive for sample size 7 SAMPLE SIZE CALCULATION The sample size is calculated by using G* POWER software, mean in group A (silk suture) is 4.05 and the standard deviation is 0.43, and the other group, group B mean is 3.42 and the standard deviation is 0.39 (from the related article) and level of significance is 5% with 80% power the total sample size in each group is 7. 6.6) INCLUSION CRITERIA 1. Patients who are having mesioangular or horizontally impacted mandibular third molar (ClassII Position B, PELL & GREGORY classification). 2. Patient in the age group of 18-35 years 3. Not allergic to the drugs or anesthetic agent used in the surgical protocol. 4. ASA Grade1 Normal healthy patients. 6.7) EXCLUSION CRITERIA 1. Pregnant or lactating patients. 2. Patients with signs of pericoronitis or active infection. 3. Patients with deleterious habits such as smoking, alcoholic. 4. Patients with poor oral hygiene 6.8) STATISTICAL ANALYSIS I. Descriptive statistics II. ANOVA / Kruskal-Wallis test |