Study design

The research was a prospective randomized control split-mouth non-blinded clinical study model to assess the impact of the KT on post-operative sequalae after surgical removal of mandibular third molar. With the cumulative 15 patients to be allocated for removal of bilateral involved mandibular third molar in near similar difficulty index 4-5 according to Pederson scale, justifying the extraction under local anaesthesia. The study was done under two groups, Group A – Test group (KT) one side of patient’s face, subjected to beige tape application. Group B – Control group (No KT) other side of patient’s face, will be the controlled group without application of KT.

Sample setting

It was a hospital based experimental study in which the patient were allocated 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: Assignment of interventions (for controlled trials)

Allocation: Study population was randomized equally (n = 15) into two different groups (Test group & control group) using computer generated table of random numbers.

Implementation: Independent observer

Blinding (masking): Non blinding study

Randomization: Simple using odd even method

Data collection, management, and analysis methods

Data collection methods: Patients reporting to OPD of “Oral and Maxillofacial Surgery department, Sharad Pawar Dental College”.

Ethics and dissemination

The study is approved from institutional ethical committee “Sharad Pawar Dental College” “[Ref. No- DMIMS(DU)/IEC/2020–21/9418].”

Declaration

The research was conducted under the Helsinki declaration 2013 and after approval by the guidelines prescribed by IEC of DMIMS DU.

Sample size

Fifteen required in each groups.

Sample size calculation

The sample size was calculated using the result of previous study of Gözlüklü Özgür et al. (2020) [4]. The following formula was used to calculate the sample size required for this study at 95% confidence interval and 80% power of the study.

$$}_= \frac_^+ _^/\upkappa )(}_}}+ }_)\right.}^}^}$$

$$}_= \frac}^ _^+/_^)(}_}}+ }_)\right.}^}^}$$

The notation for the formulae are:

\(}_\)= sample size of group 1.

\(}_\)= sample size of group 2.

σ1 = standard deviation of group 1.

σ2 = standard deviation of group 2.

∆ = difference in group means.

K = ratio = n2/n1.

z(1-α/2) = two sided Z value (eg. Z = 1.96 for 95% confidence interval).

z(1-β) = power.

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 1.

Age of 18 years and above.

2.

Bilateral impacted mandibular third molar in a near similar difficulty index.

3.

A medical history devoid of any systemic pathological conditions.

4.

A medical history devoid of any pharmacological therapy able to introduce variables into the experiment.

Criterion for exclusion 1.

Patients not willing to be a part of the study

2.

Patients with uncontrolled systemic diseases.

3.

Patients reluctant to follow instructions.

Surgical procedure

The surgical procedure involved two extractions for each patient, separated by a two-week interval. The procedure was performed by an operator under aseptic conditions following standard surgical protocols. Local anesthesia was administered using 2% lignocaine with 1:200,000 epinephrine, delivered by inferior alveolar nerve, lingual, and long buccal nerve block injections. The surgical incision was made using a No. 15 scalpel blade, and a mucoperiosteal flap was raised. Osteotomy was performed using round and fissured burs with sterile saline irrigation, and the tooth was extracted using an elevator or dental forceps. The socket was curetted, and the irregular 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, with dimensions of 5 cm × 5 m. It was cut into five equal strips, each 1 cm in width and 18 cm in length, as shown in Fig. 1. The strips were placed between the clavicle and the tragus-commissure line (Fig. 2). The tape was applied every day for 7 days. It was changed once every morning. 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), with 0 indicating no pain and 10 indicating the worst pain. 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 Fig. 3. The measurement lines were inspired from a study by Ana Carolina Heras et al. (2019) [1]. Line 1- the most posterior point of the tragus to the most lateral point of the lip commissure, Line 2- the most posterior point of the tragus to the soft tissue pogonion point, Line 3- the ala of the nose to the angle of the mandible. Maximal mouth opening that is maximum inter-incisal distance (IID) was measured post-operatively on first, second, third and seventh days by using vernier callipers.

Fig. 1

Preparation of Kinesio Taping. A The tape was cut into 5 equal strips, 1 cm in width and 18 cms in length. B Fan strips of Kinesio Tape

Fig. 2

Application of Kinesio Tape in a patient

Fig. 3

Three Reference lines for measurement of swelling

The predictor variables in our study were age, gender, difficulty index of impacted tooth. However, the inclusion criteria was such that bias due to the above mentioned factors was not significant statistically. Outcome variables were post-operative pain, swelling, interincisal mouth opening. Same post operative medications were prescribed post operatively in both the groups therefore there were no major covariables in the study.

Statistical analysis

Data so collected was tabulated in an excel sheet, under the guidance of statistician. The means and standard deviations of the measurements per group were used for statistical analysis (SPSS 22.00 for windows; SPSS inc, Chicago, USA). For each assessment point, data were statistically analyzed using one way ANOVA. Difference between two groups was determined using student t-test as well as chi square test and the level of significance was set at p < 0.05.