| CTRI Number |
CTRI/2026/01/101682 [Registered on: 20/01/2026] Trial Registered Prospectively |
| Last Modified On: |
20/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Metronidazole coated silk sutures vs conventional silk sutures in healing of wound after surgical removal of lower wisdom tooth |
|
Scientific Title of Study
|
Effectiveness of Metronidazole coated silk sutures vs conventional silk sutures in healing of wound after disimpaction surgery of mandibular third molars A Randomised Control 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 |
Savi jain |
| Designation |
Intern |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9372014412 |
| Fax |
|
| Email |
savijain2812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SR Shenoi |
| Designation |
Head of Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220505 |
| Fax |
|
| Email |
ramakrishna.shenoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SR Shenoi |
| Designation |
Head of Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre, Nagpur |
| Address |
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822220505 |
| Fax |
|
| Email |
ramakrishna.shenoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental college and Research Centre, Digdoh hills, Nagpur, Maharashtra India 440019 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre Nagpur |
| Address |
02, Department of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre
Digdoh Hills Hingna road,
Nagpur,440019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SR Shenoi |
Ranjeet Deshmukh Dental College and Research Centre and ethics committee |
02, Department of Oral and Maxillofacial Surgery
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna road
Nagpur
Nagpur
MAHARASHTRA |
9822220505
ramakrishna.shenoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics committee |
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 silk sutures |
Conventional silk sutures will be used in suturing wounds after mandibular third molar disimpaction surgery. |
| Intervention |
metronidazole coated silk suture |
Sterilised silk sutures will be coated with metronidazole and will be used in suturing wounds after mandibular third molar disimpaction surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with impacted mandibular third molars visiting OMFS OPD who require disimpaction surgery
2 Patients above 18 years of age.
|
|
| ExclusionCriteria |
| Details |
1 Patients with any systemic disease.
2 Immuno compromised patients
3 Patients with active infection
4 Pregnant or lactating females
5 Drug abusers
6 Patient with moderate alcohol consumption
7 Patients not willing to give informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of metronidazole coated silk suture and conventional silk suture in wound healing after mandibular third molar disimpaction surgery.
|
Tissue colour, Bleeding on palpation, granulation tissue, incision margin, suppuration measured postoperatively on day 1, 3 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effectiveness of metronidazole coated silk suture and conventional silk suture in wound healing after suture removal in case of mandibular third molar disimpaction surgery.
|
Tissue colour, Bleeding on palpation, granulation tissue, incision margin, suppuration measured postoperatively on day 7 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 3 |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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) |
Not Yet Recruiting |
|
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 study is designed as a randomized controlled clinical trial to evaluate and compare the effectiveness of metronidazole-coated silk sutures and conventional silk sutures in wound healing following disimpaction surgery of mandibular third molars. A total of 34 patients fulfilling the inclusion criteria will be randomly allocated into two groups using computer-generated randomization. Group A will receive metronidazole-coated silk sutures, while Group B will receive conventional silk sutures for wound closure. All surgical procedures will be performed by the same operator under standardized aseptic conditions to minimize operator bias. Postoperative wound healing will be assessed using Landry et al. healing index on postoperative day 1,3 and day 7. Postoperative parameters such as pain, inflammation, and signs of infection will also be evaluated. The study aims to determine whether local delivery of metronidazole through suture material can reduce postoperative complications and enhance wound healing, thereby improving clinical outcomes after mandibular third molar surgery. |