| CTRI Number |
CTRI/2026/03/105888 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A STUDY IN PATIENTS WITH LOWER JAW FRACTURES COMPARING TWO METHODS OF FIXING THE UPPER AND LOWER TEETH TO ANALYSE WHICH METHOD PROVIDE BETTER STABILITY AND PATIENT COMFORT. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF CONVENTIONAL ERICH ARCH BAR AND SCREW RETAINED HYBRID ARCH BAR FOR MAXILLOMANDIBULAR FIXATION IN THE CLOSED REDUCTION OF UNDISPLACED SYMPHYSIS AND PARASYMPHYSIS FRACTURES OF MANDIBLE ,A PROSPECTIVE NON RANDOMIZED COMPARATIVE CLINICAL STUDY. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAVITHAMOL MICHAEL |
| Designation |
POST GRADUATE |
| Affiliation |
Al Azhar Dental College Thodupuzha |
| Address |
ROOM NO.2 , DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, AL AZHAR DENTAL COLLEGE,PERUMPALLICHIIRA,THODUPUZHA,IDUKKI
Idukki
KERALA
685605
India |
| Phone |
7353040412 |
| Fax |
|
| Email |
savithamichael100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANKAR VINOD |
| Designation |
PROFESSOR |
| Affiliation |
Al Azhar Dental College Thodupuzha |
| Address |
ROOM NO. 2, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, AL AZHAR DENTAL COLLEGE,PERUMPALLICHIIRA,THODUPUZHA,IDUKKI
Idukki
KERALA
685605
India |
| Phone |
9895064657 |
| Fax |
|
| Email |
sankarvinodv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SAVITHAMOL MICHAEL |
| Designation |
POST GRADUATE |
| Affiliation |
Al Azhar Dental College Thodupuzha |
| Address |
ROOM NO.2,DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY, AL AZHAR DENTAL COLLEGE,PERUMPALLICHIIRA,THODUPUZHA,IDUKKI
Idukki
KERALA
685605
India |
| Phone |
7353040412 |
| Fax |
|
| Email |
savithamichael100@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAVITHAMOL MICHAEL |
| Address |
DEPT OF ORAL AND MAXILLOFACIAL SURGERY, AL AZHAR DENTAL COLLEGE, THODUPUZHA |
| 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 |
| SAVITHAMOL MICHAEL |
AL AZHAR DENTAL COLLEGE |
ROOM NO.2, DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,AL AZHAR DENTAL COLLEGE, PERUMPALLICHIRA, THODUPUZHA, IDUKKI
Idukki
KERALA |
7353040412
savithamichael100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL ERICH ARCH BARS |
GROUP A-CONVENTIONAL ERICH ARCH BARS. ARCH BARS ADAPTED FROM 1ST MOLAR TO 1ST MOLAR.SECURED USING 26G SS CIRCUMDENTAL WIRES.MMF ACHIEVED USING TIE WIRES.REMOVAL AFTER 6 WEEKS |
| Intervention |
SCREW RETAINED HYBRID ARCH BAR |
GROUP B-SCREW RETAINED HYBRID ARCH BAR. SECURED USING SELF DRILLING SCREWS.MMF ACHIEVED USING TIE WIRES.REMOVAL AFTER 6 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
UNDISPLACED MANDIBULAR FRACTURES INVOLVING SYMPHYSIS AND PARASYMPHYSIS
WITHIN 1 WEEK OF ORIGINAL TRAUMA
COMPLETE DENTITION FROM 1ST MOLAR TO 1ST MOLAR IN BOTH ARCHES SHOULD BE PRESENT |
|
| ExclusionCriteria |
| Details |
FRACTURES INDICATED FOR ORIF
PATIENTS WITH INFECTED OR PATHOLOGICAL FRACTURES
EDENTULOUS JAW
MEDICALLY COMPROMISED PATIENTS
PATIENTS WITH ADVERSE ORAL HABITS SUCH AS SMOKING AND ALCOHOL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
OCCLUSAL STABILITY
TIME FOR PLACEMENT
TIME FOR REMOVAL
|
2 WEEKS AND 6 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ARCH BAR STABILITY |
ASSESSED USING STABILITY SCORING SYSTEM |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/03/2026 |
| 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="1"
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 IS A PROSPECTIVE NON RANDOMIZED CLINICAL STUDY COMPARING CONVENTIONAL ERICH ARCH BARS AND SCREW RETAINED HYBRID ARCH BAR FOR MAXILLOMANDIBULAR FIXATION IN THE CLOSED REDUCTION OF UNDISPLACED SYMPHYSIS AND PARASYMPHYSIS FRACTURES OF MANDIBLE.THE PRIMARY OUTCOMES ARE OCCLUSAL STABILITY,TIME FOR APPLICATION AND TIME FOR REMOVAL. SECONDARY OUTCOME IS ARCH BAR STABILITY WHICH IS ASSESSED USING STABILITY SCORING SYSTEM |