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Impacted Third Molar ToothEarly Phase 1NCT02837614

Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery

A Early Phase 1 study testing dexamethasone acetate, submucosal dexamethasone injection and Third molar surgery in people with Impacted Third Molar Tooth, run by Sun Yat-sen University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Impacted Third Molar Tooth
What is being tested?
dexamethasone acetate, submucosal dexamethasone injection and Third molar surgery
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Oct 2015to Mar 2016
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read the 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

Being tested
dexamethasone acetate, submucosal dexamethasone injection, Third molar surgery, Amoxicillin and paracetamol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexamethasone acetateDrug

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

  • submucosal dexamethasone injectionDrug

    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.

  • Third molar surgeryProcedure or 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.

  • Amoxicillin and paracetamolDrug

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

Study groups in NCT02837614
Study groupRoleWhat they receive
Group A (intramuscular dexamethasone)Active comparatorIn Group A patients, 1 ml of dexamethasone (4mg) administered in the deltoid muscle before commencement of surgical procedure
Receives: Drug: dexamethasone acetate; Procedure: Third molar surgery
Group B (submucosal dexamethasone)ExperimentalIn Group B patients, 1 ml of dexamethasone was administered in submucosa after local anesthesia
Receives: Drug: submucosal dexamethasone injection; Procedure: Third molar surgery; Drug: Amoxicillin and paracetamol
Group C (control)Placebo comparatorGroup C patients continued without receiving any preoperative medication.
Receives: Procedure: Third molar surgery; Drug: Amoxicillin and paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: 1 week

  2. 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.

    Measured: 1 week

  3. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02837614
Sponsor's protocol ID
SunYat
Status last verified
Jul 2016
First submitted
25 Jun 2016
Last updated
19 Jul 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing dexamethasone acetate, submucosal dexamethasone injection and Third molar surgery in people with Impacted Third Molar Tooth, run by Sun Yat-sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of pain (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2016.

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