Health Condition 1: K011- Impacted teeth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18–65 years, ASA I–II, indicated for surgical extraction of mesioangular impacted mandibular third molars (Pell & Gregory Class I/II, Position A/B), Pedersen difficulty 4–6, consent obtained
Exclusion criteria
Exclusion criteria: Deep bony impactions, acute infection, systemic diseases affecting healing, pregnancy/lactation, allergy to study medications, prior surgery at site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome- Postoperative Trismus: Measured as the maximum interincisal distance (in millimetres) between the maxillary and mandibular central incisors using a calibrated caliper, recorded 48 hours after surgery.Timepoint: Postoperative trismus: Measured as the maximum interincisal mouth opening (in millimetres) using a Vernier caliper. Assessment will be performed preoperatively (baseline), at 48 hours, and on day 7 after surgery. These time points correspond to the peak and resolution phases of postoperative trismus. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative Pain: Assessed using a 0- 10 cm visual analogue scale (VAS) at 6, 24, 48, and 72 hours, and on day 7 after surgery. 2. Facial Swelling: Quantified at baseline, 48 hours, and day 7 using standardized linear anthropometric measurements (tragus-pogonion-[A], tragus-oral commissure – [B], and gonion-lateral canthus – [C] ) 3. Operative Efficiency: Recorded as operative time (in minutes), along with documentation of any bone removal and tooth sectioning. 4. Postoperative Complications: Incidence of complications, including infection, alveolar osteitis (dry socket), and wound dehiscence, will be recorded and compared between groups. Timepoint: a. Postoperative pain: Evaluated using a 10 cm Visual Analogue Scale (VAS) to record patient-reported pain intensity. Assessments will be carried out at 6 hours, 24 hours, 48 hours, 72 hours, and day 7 postoperatively, to capture the onset, peak, and recovery pattern of postoperative pain. b. Facial swelling: Determined by calculating the percentage change in mean facial dimensions derived from three standardized linear measurements: tragus–pogonion, tragus–oral commissure, and gonion–lateral canthus. Measurements will be taken preoperatively, at 48 hours, and on day 7 after surgery. c. Operative efficiency: Recorded intraoperatively, including the total operative time (from incision to placement of final suture) and documentation of bone removal and tooth sectioning (Yes/No). d. Postoperative complications: Complications such as infection, alveolar osteitis, and wound dehiscence will be assessed clinically at day 7 and again at the 2-week postoperative follow-up to identify both early and delayed adverse events. | — |
Countries
India
Contacts
All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD