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Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery

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ClinicalTrials.gov Identifier: NCT02837614
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Qian Tao, Sun Yat-sen University

Brief Summary:
The study composed of sixty patients, each of whom required surgical extraction of a single impacted mandibular third molar under local anaesthesia. The patients were randomly allocated to one of 3 groups of 20 each. The three groups were categorized as Group A (intramuscular dexamethasone), Group B (submucosal dexamethasone) and Group C (control). The objective measurements of facial pain, swelling, and trismus was performed by an independent examiner at baseline (preoperatively), and at days 1, 3, and 7 postoperatively.

Condition or disease Intervention/treatment Phase
Impacted Third Molar Tooth Drug: dexamethasone acetate Drug: submucosal dexamethasone injection Procedure: Third molar surgery Drug: Amoxicillin and paracetamol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A (intramuscular dexamethasone)
In Group A patients, 1 ml of dexamethasone (4mg) administered in the deltoid muscle before commencement of surgical procedure
Drug: dexamethasone acetate
1 milliliter of dexamethasone (4milligram) administered in the deltoid muscle before commencement of surgical procedure

Procedure: Third molar surgery
Surgical access was gained through standard Terrence Ward's incision to raise a full thickness mucoperiosteal flap. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation. The tooth sectioned at cemento-enamel junction whenever required and a Coupland elevator is used to elevate tooth or fragmented tooth out of socket. The socket examined for any debris and sharp bony margins smoothened. The empty socket was irrigated copiously and flap was sutured using three simple interrupted 3-0 black braided silk suture.

Experimental: Group B (submucosal dexamethasone)
In Group B patients, 1 ml of dexamethasone was administered in submucosa after local anesthesia
Drug: submucosal dexamethasone injection
Local anesthesia was achieved using 2% lignocaine hydrochloride and 1:100 000 adrenaline and a standard technique was followed to block Inferior alveolar, lingual and long buccal nerve in all patients. In Group B patients, 1 ml of dexamethasone was administered in submucosa. Investigators divided 1 ml Dexamethasone is into 0.4 milliliter, 0.3 milliliter and 0.3 milliliter parts. Following the local anesthesia, each part of dexamethasone was injected submucosally in the buccal, lingual and retromolar region around the tooth to be extracted. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation and tooth elevated. The flap was sutured using three simple interrupted 3-0 black braided silk suture. All patients were given amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively.

Procedure: Third molar surgery
Surgical access was gained through standard Terrence Ward's incision to raise a full thickness mucoperiosteal flap. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation. The tooth sectioned at cemento-enamel junction whenever required and a Coupland elevator is used to elevate tooth or fragmented tooth out of socket. The socket examined for any debris and sharp bony margins smoothened. The empty socket was irrigated copiously and flap was sutured using three simple interrupted 3-0 black braided silk suture.

Drug: Amoxicillin and paracetamol
Amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively (every 6 hours 1 tablet for 2 days).

Placebo Comparator: Group C (control)
Group C patients continued without receiving any preoperative medication.
Procedure: Third molar surgery
Surgical access was gained through standard Terrence Ward's incision to raise a full thickness mucoperiosteal flap. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation. The tooth sectioned at cemento-enamel junction whenever required and a Coupland elevator is used to elevate tooth or fragmented tooth out of socket. The socket examined for any debris and sharp bony margins smoothened. The empty socket was irrigated copiously and flap was sutured using three simple interrupted 3-0 black braided silk suture.

Drug: Amoxicillin and paracetamol
Amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively (every 6 hours 1 tablet for 2 days).




Primary Outcome Measures :
  1. Assessment of pain [ Time Frame: 1 week ]
    Postoperative pain was assessed using a visual analog scale (VAS) of 10 point scale with a score of 0 measured "no pain" and 10 correspond to "very severe pain".

  2. Trismus [ Time Frame: 1 week ]
    Mouth opening was measured using the maximum distance between the maxillary central incisors and the mandibular central incisors. The difference between sum of post-operative measurements and sum of pre-operative measurements was considered as trismus.

  3. Facial Swelling [ Time Frame: 1 week ]
    The evaluation of the facial swelling was performed by modification of Schultze-Mosgau et al method, and the facial measurements involved: 1. Tragus to the oral commissure 2.Tragus to the pogonion. The difference between sum of post-operative facial measurements and sum of pre-operative facial measurements was considered as facial swelling.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA (American Society of Anesthesiologists) class I individuals
  • Patients age between 18 - 40 years of age,
  • Patients presenting with diagnosis of Class II position B impaction (Pell and Gregory classification)
  • Patients who consent for regular recall visits

Exclusion Criteria:

  • Patients having acute infection at extraction site
  • Pregnant or lactating condition
  • Smoking or tobacco/areca nut chewing habit
  • Any systemic disease or medication therapy that could interfere with wound healing
  • Impacted tooth associated with periapical infection or lesion
  • Poor oral hygiene
  • Patients with immunocompromise conditions
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Responsible Party: Qian Tao, Dr, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02837614    
Other Study ID Numbers: SunYat
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Acetaminophen
Amoxicillin
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antipyretics