| CTRI Number |
CTRI/2025/08/092795 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Types of Stitches for lower jaw Wisdom Tooth Surgery: Polydioxanone vs Polyglactin 910 |
|
Scientific Title of Study
|
Comparison of the effect of 4-0 polydioxanone and 4-0 polyglactic 910 suture material in mandibular third molar surgery-a split mouth study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| No |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dharaneesh SK |
| Designation |
Post graduate student |
| Affiliation |
Madha dental college and hospital |
| Address |
Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
8973663196 |
| Fax |
|
| Email |
skdharaneesh98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak A Pandyan |
| Designation |
Professor & Head of the department |
| Affiliation |
Madha dental college and hospital |
| Address |
Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
9884314123 |
| Fax |
|
| Email |
dr.deepakpandyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dharaneesh SK |
| Designation |
Post graduate student |
| Affiliation |
Madha dental college and hospital |
| Address |
Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
8973663196 |
| Fax |
|
| Email |
skdharaneesh98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069 |
|
|
Primary Sponsor
|
| Name |
Dr Dharaneesh SK |
| Address |
Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069 |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 DHARANEESH SK |
Madha dental college and hospital |
Room no 05, Department of Oral and Maxillofacial Surgery, Madha dental college and hospital,
Somangalam main road ,Madha nagar ,Kundrathur,Chennai,Sikarayapuram,Tamilnadu 600069
Kancheepuram
TAMIL NADU |
8973663196
skdharaneesh98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, MADHA DENTAL COLLEGE AND HOSPITAL, CHENNAI |
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 |
| Intervention |
4-0 polydioxanone |
To compare post operative wound healing, pain, mouth opening and swelling on day 01, day 03 and day 07 post operatively |
| Comparator Agent |
4-0 polygalactin 910 suture material |
To compare post operative wound healing, pain, mouth opening and swelling on day 01, day 03 and day 07 post operatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient requiring removal of bilateral mandibular third molars with Pederson difficulty index greater than 6
2. Patients in the age group above 18 years
3. ASA-1,2 category |
|
| ExclusionCriteria |
| Details |
1.Patient with existing medical conditions
2. Immunocompromised patient
3. ASA- 3,4,5 and 6 categories |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Facial oedema
2. VAS pain score |
Immediate, 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Facial oedema
2. Soft tissue healing
3. Maximal interincisal opening
4. VAS pain score |
Third day and seventh day post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/09/2025 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 compares the effects of two types of absorbable sutures — 4-0 polydioxanone (PDS) and 4-0 polyglactin 910 (Vicryl) — used after surgical removal of lower wisdom teeth (mandibular third molars). The research evaluates healing, pain, swelling, and postoperative complications to determine which suture material offers better outcomes for patients. |