Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery

NCT02837614 | Completed Early Phase 1

• 1 other identifier: SunYat
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (3)

• Assessment of pain

  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".

  1 week

• Trismus

  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.

  1 week

• Facial Swelling

  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.

  1 week

Study Arms (3)

Group A (intramuscular dexamethasone)

ACTIVE COMPARATOR

In Group A patients, 1 ml of dexamethasone (4mg) administered in the deltoid muscle before commencement of surgical procedure

Drug: dexamethasone acetate; Procedure: Third molar surgery

Group B (submucosal dexamethasone)

EXPERIMENTAL

In Group B patients, 1 ml of dexamethasone was administered in submucosa after local anesthesia

Drug: submucosal dexamethasone injection; Procedure: Third molar surgery; Drug: Amoxicillin and paracetamol

Group C (control)

PLACEBO COMPARATOR

Group C patients continued without receiving any preoperative medication.

Procedure: Third molar surgery; Drug: Amoxicillin and paracetamol

Interventions

dexamethasone acetate DRUG

1 milliliter of dexamethasone (4milligram) administered in the deltoid muscle before commencement of surgical procedure

Group A (intramuscular dexamethasone)

submucosal dexamethasone injection DRUG

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.

Group B (submucosal dexamethasone)

Third molar surgery PROCEDURE

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.

Group A (intramuscular dexamethasone); Group B (submucosal dexamethasone); Group C (control)

Amoxicillin and paracetamol DRUG

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

Group B (submucosal dexamethasone); Group C (control)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

dexamethasone acetate; Amoxicillin; Acetaminophen

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 25, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 19, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share