Comparative Assessment of Post-Operative Sequelae Following Surgical Removal of Mandibular Third Molar with and Without Extra-Oral Application of Kinesiologic Tape

Background: The transalveolar extraction of impacted mandibular third molars creates a huge level of injury to the delicate tissues of the oral cavity, which can initiate significant inflammatory reaction. Amongst some postoperative sequelae of third molar surgeriespain, trismus and facial oedema are the most common. Treating with taping therapy has shown acceptable outcomes in reducing pain and in managing post-operative muscle spasm. Objectives: The motive behind this research is to compare post-operative pain, swelling and trismus following third molar surgery in both test and control groups. Methodology: The research will be a prospective randomized control split-mouth non-blinded clinical study model to assess the impact of the Kinesiology Tape (KT) on post-operative sequalae following removal of mandibular third molar surgically. With the cumulative 15 patients to be allocated for operating bilaterally involved impacted mandibular third molar. The study will be 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. Each patient will undergo 2 operative surgeries at 2 week-interval Study Protocol Patil and Rajanikanth; JPRI, 33(60B): 2824-2829, 2021; Article no.JPRI.80059 2825 conducted by the same surgeon. Immediately after extraction extra-oral application of KT will be done for test group. Expected Results: The use of kinesiologic tape will be effective in improvement of post-operative discomfort of the patient in the conditions of reduction of swelling, pain and trismus. Conclusion: As kinesiologic taping originates from sports medicine, currently there are very limited evidencebased scientific studies for KT application for treatment of post-operative edema in head and neck surgeries. This study will help to evaluate the use of KT enabling patients to have a restful time after operation leading them to get a better quality of life.


INTRODUCTION
Third molar surgical procedures are the most well-known procedures carried out in oral surgery that have varying complications and sequelae in preoperative, perioperative and post-operative phases.
The transalveolar extraction of impacted mandibular third molars create a huge level of injury to the delicate tissues of the oral cavity, which can initiate significant inflammatory reaction [1]. As a consequence of this, patient may experience several problems counting pain, facial oedema, haemorrhage, alveolar osteitis, neural paraesthesia, and muscle spasm causing restricted mouth opening in the post-operative period. These sequelae are more pronounced in some patients producing varying degrees of discomfort to them.
Amongst these postoperative sequelae of third molar surgeries-pain, trismus and facial oedema are the most common. Not only are they inevitable but, also a matter of concern for both, the patient and the surgeon. Hence extensive research has been done in terms of postoperative management of third molar surgeries, especially pertaining to trismus, swelling and pain. Pharmacologic manipulation has also worked to alter the inflammatory response [1]. The optimum level of pain reaches within 3-5 h after the resolution of anaesthetic effect, and is present for 2-3 days, and then slowly fades by 7th day. On the other hand, swelling reach to its upper limit within 12-48 hours and fades by 5-7 days. Conversely, trismus continues until the pain and the inflammation diminishes [2]. Facial oedema has such degree variation that it affects patient's capability to cooperate with others, as well as to restart basic and instrumental activities of everyday living, primarily in first 3 postoperative days [3].
Taping treatment has shown acceptable outcomes in managing post-operative muscle spasm and in reducing pain. In 1970, Dr. Kase invented Kinesio taping (KT) which is an 'elastictherapeutic tape' particularly used in variety of sport and health condition including postoperative rehabilitation in oral and maxillofacial surgery. The taping begins started to be used in sports and musculoskeletal conditions with the focus to assist the injured delicate tissues (muscles and joints) assisting with diminishing pain. Some researches has concluded that the KT also controls the circulation of the blood and lymphatic system and also to assist in cleansing the congestions of haemorrhagic or lymphatic fluid by impacting the skin and fluids to move according to topical application of the tape, towards the vicinity of inferior pressure from areas of superior pressure [4,5].
Recently though, KT has gained some attention in this context. Some of the recent research have advocated the usage of KT is very useful and impactful management of postoperative complications of maxillofacial surgery. Even the hypothesis for effectiveness of KT seems weaker in some researches, recent ones have provided the evidence but it opens larger area to check the effectiveness of KT in post-operative oral surgery rehabilitation.
Our motive behind this research is to find whether theoretically based findings about KT can be implemented clinically as well [6].

Study Design
The research will be a prospective randomized control split-mouth non-blinded clinical study model to assess the impact of the KT on postoperative 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 will be 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 will be a hospital based experimental study in which the patient will be allocated from the Out-Patient Department (OPD) of the "Department of oral and maxillofacial surgery, Sharad Pawar Dental College, Sawangi", Wardha'.

METHODOLOGY
Informed consent will be obtained from all patients before inclusion in the study.

Patient Selection and Preparation
The present study will be performed on patients with the age 18 years and above with impacted lower third molars who will be undergoing transalveolar extraction with respect to lower third molars in the department.
All the patients will be informed about the study and their written consent to participate in the study will be obtained. Routine analysis of blood will be done to rule out any systemic disease. Case history of the patient will be recorded.

Surgical Procedure
Each patient will undergo 2 operative surgeries by the same oral surgeon at 2 week-interval. Under standard surgical protocol, surgery will be performed in aseptic conditions. Local anaesthesia will be given on the route of inferior alveolar nerve, lingual & long buccal nerve block injection using 2% lignocaine with 1:200000 epinephrine.
The incision will be given using surgical scalpel (No.15 blade) and a mucoperiosteal flap will be raised. Osteotomy will be performed using round & fissured burs with sterile saline irrigation. Crown or root sectioning will be done as per requirement. The tooth will be extracted using an elevator or dental forceps. The socket will be curetted and irregular bone borders of alveolus will be smoothened. Repositioning of flap will be done & sutured using 3-0 silk.

Application of Kinesio Tape
Immediately after extraction application of KT application will be done for test group. The skin should be cleaned, shaved if needed, and any remaining dampness and oil will be taken out. The KT with the size of 5 cm × 5 m will be used for the study. Tape length will be modified for every patient, differentiated by the distance (in the extended neck position) between the clavicle and the tragus-commissure line. The KT will be applied into 5 equal strips with approx [6]. 1cm of width, with the base of these strips placed just above the supraclavicular nodes (the target area for drainage). To activate the acrylic adhesive, the tape is gently rubbed [7]. After tape application, skin folds will be visible as the head is placed in normal position. The tape will be kept for 7 days in each patient.
The patients will be evaluated on the following parameters -Pain: Pain to be measured postoperatively and consequently from first to third day and on the 7th day as T1, T2, T3 and T7 respectively using gold standard Visual Analogue Scale (VAS) scale [8]. Patients will be asked to rate their pain these 4 days at the same time each day and submit it on the 7th day.
Swelling: Swelling of the face to be measured by measuring tape on post-operative days, first, second, third and seventh day. The measurements will be taken in following three lines [9] mentioned in the diagram below:  Trismus: Maximal mouth opening (maximum interincisal distance (IID)) will be measured postoperatively on first, second, third and seventh days by using Vernier callipers.

Assignment of interventions (for controlled trials):
 Allocation: Study population would be 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.

Data Collection, Management, and Analysis Methods
Data collection methods: Patients reporting to OPD of "Oral and Maxillofacial Surgery department, Sharad Pawar Dental College".

Declaration:
The research will be conducted under the Helsinki declaration 2013 and after approval by the guidelines prescribed by IEC of DMIMS DU.

EXPECTED RESULTS
The use of kinesiologic tape will be effective in improvement of post-operative discomfort of the patient in the conditions of reduction of swelling, pain and trismus. The study showed edema (on 2 nd and 5 th day after extraction) and intensity of pain (on 1st, 2 nd and 5 th day after extraction) was low on the KT side (p< 0.05). In addition, swelling and pain diminished on the KT side by 5 th day of extraction (p< 0.05). Introduction of KT therapy treatment in this study was successful to reduce the swelling and postoperative pain of the patients undergoing oral surgery. According to [10] Ristow et al. (2014,2014) and Tozzy et al. (2016), patients subjected to taping therapy reduced the edema by 60%, after the second postoperative day [8,9]. In a case report by Sarah Handerson et al., a female patient (26 yrs old) underwent elective surgical extraction of her lower third molar. Kinesio tape application was done to the patient's lower mandible and masseter region for a post-surgical lymphatic drainage, results showed a major decrease in pain, swelling and trismus. The healing time was also reduced to 5 days from 10 days. It suggests that taping is potentially as an efficient treatment following surgical removal of a wisdom teeth [11]. Related studies on third molars evaluation [10,12,13] and complications related to surgical removal [14][15] were reviewed.

CONCLUSION
As kinesiologic taping originates from sports medicine, currently there are very limited evidence-based scientific studies for exploring KT application for treatment of post-operative edema in head and neck surgeries. This study will help to examine and assess the use of KT enabling patients to have a comfortable time after operation and helps them getting better quality of life [9]. It may also reduce postoperative need for NSAID and analgesics, thus reducing the side effects associated with these drugs.

CONSENT
As per international standard or university standard, patient's written consent will be collected and preserved by the author(s).