NEED OF THE STUDY The incidence of mandibular third molars impactions have seen rapid growth in recent times and owing to this, surgical extraction of mandibular third molars happen to be the most frequent intervention in oral and maxillofacial surgery. Oral surgeons worldwide have used various strategies to minimize these post-operative complications. Hyaluronic acid (HA) is also one of them. Hyaluronic acid (HA) a large non-sulphated glycosaminoglycan that is an important component of extracellular matrix (ECM) and a biodegradable polymer. By virtue of its non-immunogenicity and non-toxicity, its use has been established in many medical disciplines, such as ophthalmology, dermatology, and rheumatology. Submucosal injection of hyaluronidase (HUD) also has been applied for supraglottic airway edema following tracheostomy. Hyaluronidase injection was reported in clinical dentistry several decades ago, but prospective controlled trials for hyaluronidase injection after mandibular third molar removal is lacking. In the present study, we primarily aimed to evaluate the efficacy of submucosal hyaluronidase injection for postoperative sequelae (mouth opening limitations, facial swelling, and pain) immediately after surgical extraction of the mandibular third molar. AIM The aim of the study is to evaluate the efficacy of submucosal injection of hyaluronidase after impacted mandibular third molar surgery with respect to comparison group. OBJECTIVE The objective of this study is to assess the efficacy of submucosal injection of hyaluronidase after impacted mandibular third molar surgery with regards to following parameters: 1. Trismus 2. Post-operative pain 3. Edema 4. Patient centered outcome questionnaire (PCOQ) MATERIALS AND METHOD – Following armamentarium and materials will be required for this study - - Intraoral periapical radiographs and Orthopantomogram.
- Injection of Hyaluronidase (HUD) 1,500 International Units (IU)
- (SHREYA LIFE SCIENCES PVT. LTD.)
- 0.9% Normal saline solution (AISHWARYA LIFESCIENCES LTD.)
- 2% lignocaine hydrochloride with 1:80,000 adrenaline (LIGNOX 2%, INDOCO REMEDIES LTD.)
- Disposable 3 ml syringe and 24-gauge needle (DISPO VAN)
- Insulin syringe (DISPO VAN)
- Minor oral surgical kit
- Silk thread / Measuring tape
- Vernier Caliper
Pre-designed pilot tested Patient centered outcome questionnaire (PCOQ) METHODOLOGY - TYPE OF STUDY - Randomized Controlled Trial (RCT)
- SOURCE OF THE DATA - The study will be conducted in the Department of Oral and Maxillofacial Surgery at Chhattisgarh Dental College and Research Institute, Rajnandgaon.
- STUDY DESIGN – Hospital based Randomized Controlled Trial (RCT).
- STUDY POPULATION – Patients attending dental OPD and advised third molar extraction.
CRITERIA FOR SELECTION OF PARTICIPANTS – INCLUSION CRITERIA - - Age – 18 - 40 years
- American Society of Anesthesiologists (ASA) I: A normal healthy patient.
- Patients with impacted mandibular third molars requiring surgical extraction under local anesthesia.
- Patients with Pederson’s difficulty index score 5-6 (Moderately Difficult)
- Compliance with the study following voluntary participation.
EXCLUSION CRITERIA - Impacted third molars with associated pathology & acute infection.
- Tobacco chewers and smokers.
- Medically compromised patients.
- Patients who have a known allergy to a local anesthetic solution.
- Pregnant and lactating females or patients on oral contraceptives.
SAMPLE SIZE – With the help of openepi.com, from Lee S et al (1), calculated sample size for intervention and control group will consist of participants each 30 participants – Total 60 study participants (with 10% additional case correction for lost to follow up) SAMPLING TECHNIQUE – Convenient Sampling Technique.
METHODOLOGY - In each participant, a written informed consent will be sought. A detailed case history with the help of case record form will be taken by interviewing participants to register basic details and examination will be done to rule out any systemic conditions with uncontrolled status that contraindicate third molar surgery. After proper counselling of participants, the randomization of participants to intervention and control group will be done by coin toss method. The intervention group will be injected with submucosal injection of Hyaluronidase (HUD), 1500International Units ( IU) /ml and other group shall be injected with saline water. In this study, double blinding shall be maintained throughout the study to avoid introduction of selection bias; neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over. The participants shall be followed up on Day 1, Day 3 and Day 7 in person visit, and shall be assessed over the outcome parameters of trismus, pain and oedema. Any participants with any type of side effect shall be counselled for immediate in person follow up in Out Patient Department (OPD) or can call telephonically to investigators.
SURGICAL PROCEDURE In the intervention group, local anesthesia will be achieved with the help of standard 2% lignocaine hydrochloride with 1:80,000 adrenaline, Ward’s / Modified Ward’s incision will be given, the buccal mucoperiosteal flap elevated & mandibular third molar will be extracted with odontomy and ostectomy followed by submucosal injection of Hyaluronidase (HUD)1500 IU/ml. The flap was adapted to the wound margin and sutured after submucosal injection of hyaluronidase (HUD) 1,500 International Units. A total of 1.0 mL will be injected in the base of a mucoperiosteal flap, 0.5 mL in the mesial margin and 0.5 mL in the distal margin. On the control side, a saline solution of 1.0 mL will be administered as a placebo in the same manner. All participants will undergo the standard procedure for surgical removal of impacted mandibular third molars. A prophylactic course of medications will be given: • Tab. Amoxicillin + Clavulanic Acid 625 mg for 3 days • Tab. Ketorolac 10 mg for 3 days • Tab. Pantoprazole 40 mg for 3 days Patients will be called for post-operative assessment on 1st, 3r d and 7th post-operative day. |