Intraosseous Versus Submucosal Dexamethsone Injection in Third Molar Surgery

NCT06720051 | Not Yet Recruiting DMC

• 1 other identifier: U1111-1315-4156
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if intraosseous dexamethasone injection is better for pain and swelling postop 3rd molar surgery than submucosal dexamethasone injection. The main questions it aims to answer are: Does intraosseous dexamethasone injection provide better pain relief and lessen facial swelling than submucosal dexamethasone injection Does intraosseous dexamethasone injection provide better interincisal opening than submucosal dexamethasone injection Researcher will compare both the techniques to see if intraosseous dexamethasone injection works better than submucosal dexamethasone injection Participants will: Be assessed at 3rd and 7th day postoperatively Pain will be assessed through visual analog scale score Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw. Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler

Conditions

Third Molar Surgery

Keywords

intraosseous dexamethasone injection; submucosal dexamethasone injection; Third molar surgery; facial pain in third molar surgery; facial swelling in 3rd molar surgery; interincisal opening in third molar surgery

Outcome Measures

Primary Outcomes (3)

• Pain

  Pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage. Pain will be assessed using visual analogue scale (VAS), which is a self-administered continuous scale comprised of a line of 10 cm in length, anchored by "no pain (score 0)" and "pain as bad as it could be (score 10)". The patient is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity; and score is determined by measuring the distance between "no pain (score 0)" anchor and the patient's mark. A higher score indicates greater pain intensity

  3rd and 7th day post operatively

• Interincisal opening

  Interincisal opening will be measured from the incisal edge of the maxillary central incisors to the incisal edge of mandibular central incisors at the midline by using millimeter ruler

  3rd and 7th day post operatively

• Facial swelling

  Facial swelling is the buildup of fluid in the tissues of the face. Facial measurement will be calculated as horizontal measurement plus vertical measurement divided by 2, where horizontal measurement will be taken as the distance between corner of the mouth and the earlobe attachment, and vertical measurement will be taken as distance from outer canthus of the eye to the angle of jaw

  3rd and 7th day post operatively

Study Arms (2)

Group A will undergo intraosseous dexamethasone injection after 3rd molar surgery

EXPERIMENTAL

In Group A, patients will receive 4 mg dexamethasone intraosseous injection into the bone distal to the socket of impacted third molar immediately after extraction of the third molar and before suturing

Procedure: Intraosseous dexamethasone injection after 3rd molar surgery

Group B will undergo submucosal dexamethasone injection after 3rd molar surgery

ACTIVE COMPARATOR

In Group B, patients will receive 4 mg dexamethasone submucosal injection into the buccal vestibule opposite to the surgical site of impacted third molar immediately after surgery.

Procedure: Submucosal dexamethasone injection after 3rd molar surgery

Interventions

Intraosseous dexamethasone injection after 3rd molar surgery PROCEDURE

In Group A, patients will receive 4 mg dexamethasone intraosseous injection into the bone distal to the socket of impacted third molar immediately after extraction of the third molar and before suturing

Group A will undergo intraosseous dexamethasone injection after 3rd molar surgery

Submucosal dexamethasone injection after 3rd molar surgery PROCEDURE

In Group B, patients will receive 4 mg dexamethasone submucosal injection into the buccal vestibule opposite to the surgical site of impacted third molar immediately after surgery.

Group B will undergo submucosal dexamethasone injection after 3rd molar surgery

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing mandibular third molar surgery
• Age 18 to 35 years
• Male and female

You may not qualify if:

• Uncontrolled systemic medical problems including diabetes and hypertension
• Presence of any cyst, tumor, or other pathological condition in the molar area
• Presence of any craniofacial anomalies, congenital deformities or syndromes
• Patients with known adverse effects of steroid use
• Previous history of orthodontic treatment
• Have a pain disorder or taking pain medications
• Pregnant and lactating mothers

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

• Sirintawat N, Sawang K, Chaiyasamut T, Wongsirichat N. Pain measurement in oral and maxillofacial surgery. J Dent Anesth Pain Med. 2017 Dec;17(4):253-263. doi: 10.17245/jdapm.2017.17.4.253. Epub 2017 Dec 28.

  PMID: 29349347 BACKGROUND

Central Study Contacts

Mahreen Mahmood, BDS

CONTACT

092-3319440050; mahreenmahmood510@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OMFS Resident

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: June 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)