STUDY DESIGN:
The study was a prospective randomized control study. It was a split-mouth clinical study, designed to assess the efficacy of KT on post-operative manifestations after transalveolar extraction of mandibular third molar. The study was non blinded. Fifteen patients were included in the study for extraction of bilaterally impacted mandibular third molars with a similar difficulty score of 4-5 according to Pederson’s difficulty index. The oral cavity was divided into two groups. Group A was the ‘Test group’ (KT group) in which one side of patient’s face was subjected to application of Kinesiologic tape. Group B was the Control group (No KT) which was the other side of patient’s face, on which KT was not applied.
SAMPLE SETTING
The patients were selected from the Out-Patient Department (OPD) of the “Department of Oral and Maxillofacial Surgery, Sharad Pawar Dental College, Sawangi, Wardha’.
STUDY DURATION: November 2021- November 2022
Methods: Assigning interventions (for controlled trials):
- Allocation: Study population was divided randomly into 2 equal groups -Test group (KT) & control group (No KT) using table of random numbers.
- Blinding: Non blinding study
- Implementation: Independent observer
- Randomization: Simple using odd even method
Data collection, management and methods for analysis:
Data collection methods: Patients visiting OPD of “Oral and Maxillofacial Surgery department, Sharad Pawar Dental College”.
Ethics and dissemination:
This study is approved from institutional ethical committee “Sharad Pawar Dental College” “[Ref. No- DMIMS(DU)/IEC/2020-21/9418].”
Declaration: This research was done after approval by the guidelines agreed by IEC of DMIMS DU and was conducted under the Helsinki declaration 2013.
SAMPLE SIZE: 15 in both the groups
SAMPLE SIZE CALCULATION:
The sample size was calculated using the result of previous study of Gözlüklü Özgür et al (2019)[4]. The calculation of the sample size required for this study used the following formula at 95 percent confidence interval and 80 percent power of the study.
The testing of the Hypothesis for two means (equal variances), Standard deviation in group 1, SD1= 9.08. Standard deviation in group 2, SD2=6.88, (SP= SD1 + SD2/ 2); Mean difference between 1st and 2nd sample = 8.22, Effect size=1, Power (%)=80, Sided-2, where Z1-α/2 is critical value of the normal distribution at 1-ɑ/2 (confidence level of 95%, the critical value is 1.96 and ɑ is 0.05), the critical value is Z1-β of the normal distribution at 1-β (power of 80%, β is 0.2 and the critical value is 0.84), and ∆ is the mean difference in groups .
n = 15
Therefore, the calculated sample size for this study was 15 per group keeping in mind the distribution was made equally, 15 subjects allotted in study group ( with KT ) and control group (No KT).
CRITERION For INCLUSION:
- Age of 18 years and above.
- Bilaterally impacted mandibular third molar in a near similar difficulty index.
- A medical history devoid of any systemic conditions.
- A medical history able to introduce variables into the experiment and is devoid of any pharmacological therapy.
CRITERION FOR EXCLUSION:
- Patients with dissimilar type of 3rd molar impactions.
- Patients not willing to participate in the study.
- Patients presenting with uncontrolled systemic diseases.
Surgical procedure:
The surgical procedure involved two extractions for each patient, separated by a two-week interval. The procedure was performed by a single operator under aseptic conditions following standard surgical protocols. Local anesthesia was administered using 2% lignocaine with 1:200,000 epinephrine injected for appropriate nerve blocks. Incision was made using no. 15 surgical blade and a full thickness mucoperiosteal flap was elevated. Osteotomy was performed via round & fissured burs with irrigation of sterile saline, and the tooth was extracted using dental forceps or an elevator. The socket was curetted, and the uneven bone borders of the alveolus were smoothed. Finally, the flap was repositioned and sutured using 3-0 silk.
Application of Kinesio Tape:
Following extraction, Kinesio Tape (KT) was applied to test group 1. The tape used was Kinesio Tex Gold Finger Print. It was cut into five equal strips, each 1 cm in width and 18 cm in length, as shown in Figure 1. The strips were placed between the clavicle and the tragus-commissure line. The patients were assessed for pain, swelling, and trismus. Pain was evaluated subjectively on postoperative days 1 (T1), 2 (T2), 3 (T3), and 7 (T7) using a Visual Analog Scale (VAS), where 0 indicating no pain & 10 indicating the worst. Facial swelling was measured using a measuring tape on preoperative and postoperative days 1, 2, 3, and 7. The measurements were taken in the three lines as shown in Figure. 2. The measurement lines were inspired from a study by Ana Carolina Heras et al. (2019)(1). Line 1- from the most lateral point of the lips to the most posterior point of the tragus, Line 2- from the soft tissue pogonion point to the most posterior point of the tragus, Line 3- from angle of the mandible to the ala of the nose. Maximal mouth opening that is maximum inter-incisal distance (IID) was measured by using vernier callipers, post-operatively on 1st, 2nd, 3rd and 7th days
Statistical analysis: Under the guidance of the statistician, data was collected and tabulated in an excel sheet. The standard deviations and means of the measurements for each group were gathered for statistical analysis (SPSS 22.00 for windows; SPSS inc, Chicago, USA). The data was statistically analyzed for each assessment, using one way ANOVA. The use of student t-test along with chi square test determined the difference between two groups and the level of significance was kept at p < 0.05.