| CTRI Number |
CTRI/2022/02/040352 [Registered on: 16/02/2022] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MINIPLATE DESIGN] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ASSESSMENT OF A MODIFIED BONE FIXATION PLATE FOR TREATMENT OF LOWER JAW FRACTURES |
|
Scientific Title of Study
|
EVALUATION OF A MODIFIED TITANIUM MINIPLATE FOR THE TREATMENT OF MANDIBULAR ANGLE FRACTURES: A PROSPECTIVE CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JAKKIREDDY PRASANNA KUMAR |
| Designation |
POST GRADUATE |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of oral and maxillofacial surgery, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE-524002.
Nellore
ANDHRA PRADESH
524002
India
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
7893584807 |
| Fax |
|
| Email |
pjreddy1394@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D SATHYA KUMAR |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of oral and maxillofacial surgery, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE-524002.
Nellore
ANDHRA PRADESH
524002
India
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9441127171 |
| Fax |
|
| Email |
satyadevireddy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D SATHYA KUMAR |
| Designation |
PROFESSOR & HEAD OF THE DEPARTMENT |
| Affiliation |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
| Address |
Dept of oral and maxillofacial surgery, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE-524002.
Nellore
ANDHRA PRADESH
524002
India
Nellore
ANDHRA PRADESH
524002
India |
| Phone |
9441127171 |
| Fax |
|
| Email |
satyadevireddy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NARAYANA DENTAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
Dr JAKKIREDDY PRASANNA KUMAR |
| Address |
ROOM.NO:2, GROUND FLOOR, NARAYANA DENTAL COLLEGE AND HOSPITAL, CHINTHAREDDYPALEM, NELLORE-524002 |
| 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 |
| JAKKIREDDY PRASANNA KUMAR |
NARAYANA DENTAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY,ROOM NUMBER 2, narayana dental college and hospital, nellore
Nellore
ANDHRA PRADESH |
7893584807
pjreddy1394@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: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MODIFIED DESIGN TITANIUM NON-COMPRESSION MINIPLATE |
Evaluation of the stability and adequacy of reduction of a modified design non-compression titanium miniplate in mandibular angle fractures. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients age > 18 yrs and < 55 yrs.
2. Patients with unilateral or bilateral angle fractures
3. Co-existing fractures of mandible at sites along with angle fractures
4. Angle fractures in partially edentulous and completely dentulous patients. |
|
| ExclusionCriteria |
| Details |
1. Patients who are not fit for general anesthesia.
2. Patients who don’t give consent for study.
3. Comminuted fractures at the angle region.
4. Infected/malunited fracture of the mandibular angle
5. Completely edentulous patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of the stability and adequacy of reduction of a modified non-compression titanium miniplate in mandibular angle fractures |
1WEEK, 1MONTH, 3MONTHS, 6MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
23/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Facial bone fractures are common following assaults, motor vehicle accidents
and falls & among these fractures 40% of them involve the mandible. 2. Among this 40%, 30-40% of fractures involve mandibular angle region and
Angle fractures continue to generate complication rates as high as 32% and are
challenging for management. 3. Champy and others have described the ideal line of osteosynthesis which is now
well known and accepted, forming the basis of internal fixation using mini-plates
and screws. 4. Recently locking mini plate monocortical fixation approach has gained
popularity, and studies have described low complication rates of 12-16%
especially with the use of champy’s technique but however the stability of single
mini-plate fixation at angle has been challenged in more recent biomechanical
studies. 5. A new non-compression miniplate has been designed that provides similar
advantages to the Champy technique. 6. This new miniplate differs from others used in the treatment of mandibular angle
fractures by offering more adequacy of fixation and stability to the lateral
displacing forces at the fracture site than conventional single miniplates and it
could be useful in treatment of non-comminuted, non-complicated, and
minimally displaced mandibular angle fractures. |