| CTRI Number |
CTRI/2025/10/096614 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Frijo Xavier |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD |
| Address |
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA
508126
India |
| Phone |
08884070768 |
| Fax |
|
| Email |
drfrijoxavier@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Frijo Xavier |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD |
| Address |
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA
508126
India |
| Phone |
08884070768 |
| Fax |
|
| Email |
drfrijoxavier@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Negi |
| Designation |
professor and head |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD |
| Address |
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA
508126
India |
| Phone |
9868604172 |
| Fax |
|
| Email |
dranurag.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES BIBINAGAR HYDERABAD, india 508126 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BIBINAGAR HYDERABAD |
| Address |
bibinagar , hyderabad, telangana, india PIN - 508126 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Frijo Xavier |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, bibinagar, hyderabad |
Room no 4, ground floor, AYUSH Building,All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD
Nalgonda
TELANGANA |
8884070768
drfrijoxavier@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS) Bibinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Ward’s Incision |
A standard triangular mucoperiosteal flap with an anterior releasing incision beginning at the distobuccal line angle of the mandibular second molar, extending obliquely into the buccal vestibule, a sulcular incision along the buccal gingival margin of the second molar, and a distal releasing limb extending posterolaterally toward the external oblique ridge. This design provides broad surgical access for third molar removal. The flap will be raised under local anaesthesia, followed by bone guttering and tooth sectioning as required. The wound will be closed using 3-0 black silk sutures. |
| Intervention |
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 distobuccal corner of the mandibular second molar and curves anterolaterally toward the vestibule, terminating near the mesiobuccal line angle. The second limb runs along the cervical margin of the third molar without any distal release. The distal soft tissues are gently undermined to achieve adequate exposure for tooth removal. Following extraction, two sutures will be placed—one securing the papilla distal to the second molar and one across the extraction socket—while leaving the anterior limb unsutured to allow dependent drainage. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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 |
|
| ExclusionCriteria |
| Details |
Deep bony impactions, acute infection, systemic diseases affecting healing, pregnancy/lactation, allergy to study medications, prior surgery at site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
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.
|
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. |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This research project investigates the postoperative outcomes of two surgical flap designs, the conventional Ward’s incision and a modified version without a distal releasing incision for the extraction of impacted mandibular third molars. Surgical removal of these teeth is a routine procedure but often leads to complications such as pain, swelling, and restricted jaw movement (trismus). While the conventional Ward’s flap provides excellent surgical access, it may contribute to greater postoperative discomfort due to its extensive tissue reflection. A modified approach that eliminates the distal releasing incision has been proposed to reduce these complications while maintaining sufficient surgical access. However, there is a lack of high-quality comparative studies on this topic. The primary objective of this study is to determine whether the modified Ward’s incision results in reduced postoperative morbidity compared to the conventional method. Secondary objectives include comparing pain lefvels, facial swelling, operative efficiency, and complication rates between the two techniques. The study will be conducted as a randomized controlled trial at the Department of Dentistry, AIIMS Bibinagar, involving 54 participants (27 in each group) aged 18–35 years. Patients will be randomly assigned to either the conventional or modified flap group, with outcomes assessed at multiple time points post-surgery. The findings are expected to provide evidence-based recommendations for oral surgeons, potentially improving patient comfort and recovery after third molar surgery. By addressing a gap in current research, this study could influence clinical practice by supporting the adoption of a less invasive flap design with comparable efficacy. Key measurements will include interincisal mouth opening (to assess trismus), pain scores using a visual analogue scale (VAS), and facial swelling through standardized linear measurements. Operative time, need for bone removal, and complications such as infection or dry socket will also be recorded. Statistical analysis will compare outcomes between groups, with adjustments for baseline differences. The study anticipates that the modified flap will lead to better postoperative recovery, including less trismus, reduced pain, and decreased swelling, without compromising surgical success |