Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Early Phase 1

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.
    

Detailed description: 
      The study was conducted as a prospective randomized comparative clinical study at the
      Department of Oral and Maxillofacial Surgery, Guanghua School of Stomatology, Sun Yat-sen
      University, Guangzhou and included 60 patients who needed surgical removal of a single
      impacted mandibular third molar under local anaesthesia. The study included 37 male and 13
      female with age ranging from 20 to 40 years. Ethical approval was obtained from the
      Institutional Ethics Committee of Guanghua School of Stomatology, Sun Yat-sen University
      prior to the beginning of the study. The signed consent form obtained from all the patients
      after explaining the risks and benefits of the surgical procedure.

      All the Sixty patients were randomly assigned to one of 3 groups of 20 each irrespective of
      age and sex using single-blind technique. The three groups were categorized as Group A
      (intramuscular dexamethasone), Group B (submucosal dexamethasone) and Group C (no steroid).
      Group A was given 8mg intramuscular dexamethasone, Group B was administered with 4mg
      submucosal dexamethasone and the Group C had no steroid injection.

      The surgical procedure performed was same for all patients by the same operator. 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 A patients, 1 ml of dexamethasone (4mg) administered in the deltoid
      muscle before commencement of surgical procedure. In Group B patients, 1 ml of dexamethasone
      was administered in submucosa after local anesthesia and the Group C patients continued
      without receiving any preoperative medication. In Group B, to standardize the drug delivery
      in third molar region the investigators followed the method described by Arakeri et al.6 for
      third molar surgery. According to the technique, the investigators divided 1 ml Dexamethasone
      (4mg) is into 0.4 ml, 0.3 ml and 0.3ml parts. Following the local anesthesia, each part of
      dexamethasone was injected submucosally in the buccal (0.3 ml), lingual (0.3 ml) and
      retromolar (0.4 ml) region around the tooth to be extracted (Figure1, 2, 3).

      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. A small gauze pack was placed over the wound and routine post-extraction
      instructions advised to patient. The duration of procedure from incision to the last suture
      was documented.

      All patients were given amoxicillin 500 mg every 8 h orally for 5 days, and 500 mg of
      paracetamol postoperatively (every 6 h 1 tablet for 2 days). Patients are instructed to not
      to seek medical help for any postoperative discomfort without prior information to the
      surgeon.

      The patients were recalled postoperatively on 1-, 3 and 5 days to record swelling, trismus
      and pain.

      Pain, mouth opening, and facial swelling were objectively recorded at the first, third, and
      seventh postoperative days by an independent examiner.

      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".18 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. The evaluation of the facial swelling
      was performed by modification of Schultze-Mosgau et al method,19 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.

      The data were tabulated and electronically stored. Descriptive statistics were mean (standard
      deviation) used to present the data. Chi square test and the analysis of variance (ANOVA), as
      appropriate, was used to assess the significance of differences. The level of significance
      less than 0.05 (P < 0.05) were considered as significant. Statistical analysis was performed
      using Statistical Package for the Social Sciences (SPSS) version 21
    

Intervention name(s): dexamethasone acetate; submucosal dexamethasone injection; Third molar surgery; Amoxicillin and paracetamol
Intervention type(s): Drug; Drug; Procedure; Drug
Intervention description(s): 1 milliliter of dexamethasone (4milligram) administered in the deltoid muscle before commencement of surgical procedure; 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.; 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.; Amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively (every 6 hours 1 tablet for 2 days).
Intervention MeSH terms: Acetaminophen; Amoxicillin; Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment