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A study to compare two surgical methods for removing lower wisdom teeth — one using a modified incision and the other using the traditional incision — to see which is safer and more effective.

Efficacy and Safety of Modification of Ward’s Incision Without Distal Release Versus Conventional Ward’s Incision in Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096614
Enrollment
88
Registered
2025-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K011- Impacted teeth

Interventions

Intervention1: Modification of Ward incision design Without Distal Release: A two-limb conservative mucoperiosteal flap designed to omit the distal releasing incision. The first limb begins at the dis

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES BIBINAGAR HYDERABAD
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Anurag Negi

All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD

drfrijoxavier@gmail.com08884070768

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026