Role of intravenous anti-oedema drug in "piezo-assissted" extraction of third molar.
- Conditions
- Patients who are diagnosed with partially or unerupted third molar requiring "piezo-assissted" surgical dental extraction.
- Registration Number
- CTRI/2020/04/024891
- Lead Sponsor
- Rahul Mukul Chaubey
- Brief Summary
Title of the study : Influence of intra-venous Dexamethasone in controlling post-operative complications in piezo-assisted third molar surgery.
Type of study : Prospective, Interventional.
Study period : 18 months ( 1 year and 6 months)
Aim of the study : To assess wheather administration of intra-venous dexamesthasone is instrumental to reduce post-operative complications following piezo-assisted third molar surgery.
Objectives of the study :
1) To administer intra-venous dexamethasone in test group of patients undergoing piezo-assisted third molar surgery.
2) To compare post-operative pain using VAS scale in both test and control group of patients.
3) To compare mouth opening/trismus using vernier caliper in both test and control group of patients.
4) To assess wheather piezo-assisted third molar surgeries require intra-venous dexamethasone to control post-operative complications.
Sample size : 60 patients above 18 years of age, divided into 2 groups based on block method of randomization (ABAB, AABB, ABBA, BABA, BBAA)
Group 1 : 30 patients (piezo-assisted impacted third molar surgery)
Group 2 : 30 patients (piezo-assisted impacted third molar surgery + Injection dexamethasone)
Detailed description of the procedure :
The study will be conducted in the Department of Oral and Maxillofacial Surgery, MCODS, Manipal. A detailed written informed consent will be obtained from each patient. Patients will be asked to rinse the oral cavity with 2% povidine-iodine solution 5 minutes prior to the procedure. All procedures will be performed by a single surgeon under local anaesthesia blockade of an inferior alveolar nerve (IAN), lingual and long buccal nerve block using 2% lidocaine hydrochloride with 1:200000 adrenaline. A modified wards’s incision with distal extension will be placed and full thickness mucoperiosteal flap will be reflected to expose the impacted teeth and surrounding bone. Following this piezosurgical unit and bone cutting piezo tips ( ACETON) and tooth cutting ninja tips (ACETON) will be used for carrying out trans-alveolar extraction of third molar. The wound closure will be achieved by placing using 3-0 black braided silk sutures. In group 2, post-operatively, all the patients will be administered injection. Dexamethasone 4mg. The post-operative follow-up will be scheduled on 1st, 3rd and 7th day. We will compare these parameters :
1) To compare post-operative pain using VAS scale in both test and control group of patients.
2) To compare swelling using facial measurements in both test and control group of patients.
3) To compare mouth opening/trismus using vernier caliper in both test and control group of patients.
Potential risks : Patients will be required to spend time during the pre-operative and post-operative follow up period. Chances of pain / oedema / trismus following impacted lower third molar removal.
Potential benefits : In clinical practice, piezo surgery plays an important role in reducing post-operative pain, trismus and also swelling. Supplementation with injection dexamesthasone will enhance its post-operative complications reducing effect.
Budget : Self-funded (Not applicable)
Ethical considerations and method to address issues : Ethical committee clearance and CTRI approval shall be taken prior to initiation of the study.
Compensation : Storage and maintenance of all trial database will be done for a period of 3 years. Reporting of adverse events will be done to Institutional Ethics Committee, Kasturba Hospital, Manipal. No compensation will be given to be a part of the study, however, compensation will be given in case of any adverse events/ injury during the period of the study by principal investigator. The study does not have any conflict of interest.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
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- Patients who are willing to participate in the study.
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- Patients above 18 years of age.
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- Pederson difficulty index 3-5.
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- ASA 1 (American society of Anaesthesiologists)/ASA 2 patients.
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- Patients on cardiac pacemakers.
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- Patients with systemic disease and drug allergy.
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- Patients with acute infection at the time of surgery such as pericoronitis, acute alveolar abscess.
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- Patients with dense sclerotic bone disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pain, oedema and mouth opening/trismus post-operatively after impacted third molar surgery with piezoelectric device with or without intra-venous dexamethasone. At the end of the study.
- Secondary Outcome Measures
Name Time Method The study will help in understanding the effect of intra-venous dexamethasone and help in better planning of third molar extractions. At the end of the study.
Trial Locations
- Locations (1)
Manipal College of Dental Sciences, Manipal
🇮🇳Udupi, KARNATAKA, India
Manipal College of Dental Sciences, Manipal🇮🇳Udupi, KARNATAKA, IndiaRahul Mukul ChaubeyPrincipal investigator8888822998chaubey27@gmail.com