| CTRI Number |
CTRI/2025/07/091745 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARATIVE EVALUATION OF THE SUTURELESS AND MULTIPLE SUTURE TECHNIQUE IN THIRD MOLAR IMPACTION: A CLINICAL TRIAL |
|
Scientific Title of Study
|
Comparative Evaluation of the Sutureless and Multiple Suture Technique in Third Molar Impaction: A Clinical 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 |
ISHITA RANGNANI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPT OF ORAL AND MAXIILOFACIAL SURGERY, ROOM NO 2 KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE Moradabad UTTAR PRADESH 244001 India |
| Phone |
9358837602 |
| Fax |
|
| Email |
ishitarangnani@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PRANSHU CHAUHAN |
| Designation |
READER |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
ROOM NO 104, STAFF QUARTERS, KOTHIWAL DENTAL COLLEGE
Moradabad UTTAR PRADESH 244001 India |
| Phone |
8077963158 |
| Fax |
|
| Email |
chauhanpranshu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PRANSHU CHAUHAN |
| Designation |
READER |
| Affiliation |
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE |
| Address |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO. 2, KOTHIWAL DENTAL COLLEGE
UTTAR PRADESH 244001 India |
| Phone |
8077963158 |
| Fax |
|
| Email |
chauhanpranshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| KOTHIWAL DENTAL COLLEGE, MORADABAD |
|
|
Primary Sponsor
|
| Name |
ISHITA RANGNANI |
| Address |
314, Kothiwal Dental College, Moradabad, Uttar Pradesh 244001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ISHITA RANGNANI |
KOTHIWAL DENTAL COLLEGE |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY, ROOM NO. 2 Moradabad UTTAR PRADESH |
9358837602
ishitarangnani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS AND REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z40-Z53||Encounters for other specific health care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Multiple Sutures |
Multiple sutures are given in incision site during third molar impaction surgery. |
| Intervention |
Suture-less technique |
No sutures are given in incision site during third molar impaction surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-American Society of Anaesthesiologists (ASA) physical status I subjects between 20 and 50 years of age, both male and female were included in the study.
-Indications for extraction of a single impacted mandibular third molar under local anaesthesia
-Patients with mesioangular, distoangular, horizontal and vertical impactions according to Winter’s classification
-Absence of symptoms such as facial swelling or limited mouth opening from any cause within 5 days preceding surgery.
|
|
| ExclusionCriteria |
| Details |
- Pregnant females, lactating mothers
- History of allergy to the drugs used in this study.
- Patients not willing for the procedure or not willing to give written informed consent.
- Medically compromised patients.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain |
Post-operative day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain, Oedema, trismus, complications, flap healing in the experimental arm, analgesic consumption, Quality of life |
DAY 0, 7 AND 28 |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="3" 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
|
Comparative evaluation
of the sutureless and multiple suture technique in third molar impaction: a
clinical TRIAL
One of the most
frequent procedures in oral and maxillofacial surgery is the surgical extraction
of mandibular third molars. The average incidence of third molar impaction is 24.40%
approximately with significant regional variations1. Although
environmental characteristics are more likely to be the cause of these
differences, genetic factors may play a role. Primary closure of the operating
site is usually advocated but is not always essential as advocated by the
French Health Authority (HAS)2. There is still debate regarding the
optimal surgical methods, particularly with regards to the mucosal closure after
surgical removal of impacted mandibular third molar. The two approaches used
are to allow for healing by either primary or secondary intention. Suturing of sockets
after extraction is recommended by some groups on the grounds that wound
approximation help in bleeding control and decreases the contamination of operative
site and therefore, enhance the rate and quality of healing. Others, however,
favor healing by secondary intention because it allows the surgical site to
naturally drain, lowering the risk of inflammatory response. Dubois et al. compared hermetic closure to
sites where the mesial portion of the wound was allowed to heal through
secondary intention.3
On the fifth day, wound dehiscence was noted in fifty percent of the
hermetically sutured patients, though no infection was present. They also found that sutured patients had a tendency for incomplete
closure, even though there were no changes in postoperative swelling, pain, or
infection. Following the extraction of an impacted wisdom tooth, subsequent
research has compared surgical site closure methods.4–6. None,
however, have assessed quality of life, pain, oedema, trismus, complications,
and the use of painkillers after more than seven days following surgery in a
sizable cohort. Although the results showed significant heterogeneity because
of the variations in the incision techniques used, a meta-analysis of five studies
found that secondary closure reduced pain7. There is currently not
enough data to determine whether alveolar osteitis, infection, or bleeding
responds better to primary or secondary healing.
|