| CTRI Number |
CTRI/2022/01/039399 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
23/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of a "new Herbert screw" with standard plating for fracture of lower anterior jaw |
|
Scientific Title of Study
|
Comparison of Herbert cannulated bone screw (HBS 2) with miniplates for the osteosynthesis of the anterior mandibular fracture: An Exploratory randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adity Bansal |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Dentistry (Oral & Maxillofacial Surgery) All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9876611900 |
| Fax |
|
| Email |
aditybansal@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashi Chug |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Dentistry (Oral & Maxillofacial Surgery) All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand
Department of Dentistry (Oral & Maxillofacial Surgery) All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9876611900 |
| Fax |
|
| Email |
ashichug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adity Bansal |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Rishikesh |
| Address |
Department of Dentistry (Oral & Maxillofacial Surgery) All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9876611900 |
| Fax |
|
| Email |
aditybansal@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, 249203 |
|
|
Primary Sponsor
|
| Name |
Dr Adity Bansal |
| Address |
Department of Dentistry (Oral & Maxillofacial Surgery), All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, 249203 |
| Type of Sponsor |
Other [Other (Self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ashi Chug |
Department of Dentistry (Oral & Maxillofacial Surgery), All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, 249203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Adity Bansal |
AIIMS, Rishikesh |
Department of Dentistry (Oral & Maxillofacial Surgery), Level II, All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand, 249203
Dehradun
UTTARANCHAL |
9876611900
aditybansal@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M264||Malocclusion, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HBS 2 midi long thread osteosynthesis |
2 screws will be used: Screws used will be of defined dimension: 30mm overall length, blank shaft diameter of 2.0 mm; with proximal thread length of 5mm and diameter of 3.9mm; and distal thread length of 11 mm and diameter of 3.0 mm
Duration: 6 months |
| Comparator Agent |
HBS 2 mini long thread osteosynthesis |
2 screws will be used: Screws used will be of defined dimension: 30mm overall length, blank shaft diameter of 1.7mm; with proximal thread length of 5mm and diameter of 3.2 mm; and distal thread length of 11 mm and diameter of 2.5 mm
Duration: 6 months |
| Intervention |
Miniplates |
2.0 mm sub-apical miniplate with 4 holes; 2.0mm lower border miniplate with 6 holes
Duration: 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with anterior mandibular fractures (symphysis or parasymphysis fracture mandible)
Patients with anterior mandibular fractures (symphysis or parasymphysis fracture mandible), associated with additional maxillary or other associated facial fractures will also be included, unless anterior mandible requires reconstruction plate fixation
Age >18 and less than 50 years
Patients presenting within one week of fracture incident
|
|
| ExclusionCriteria |
| Details |
Patients with age of 18 years or less; or more than 50 years
Communited anterior mandibular fractures requiring obvious management with reconstruction plating
Patients with active infection (pus) at the site of fracture
Patients with bone loss at the site of fracture
Mal-united fractures or fractures presenting more than 1 week late
Edentulous patients requiring reconstruction plate
Patient with medical co-morbidities like neurological disorders or low GCS (Glasgow Coma Scale); spine/cervical injuries; uncontrolled diabetes; uncontrolled hypertension, cardio-vascular disorders, bleeding disorders: which contra-indicate surgical management.
Patient with known cancer or undergoing/having history of radio-therapy/chemo-therapy.
Patient who are active smokers/alcoholic
Pregnant patient
Patients lost to follow up
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare stability of the osteosynthesis by evaluating inter-fragmentary mobility, which will be done by bimanual palpation |
3 weeks, 6 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative occlusion |
3 weeks, 6 weeks, 3 months, 6 months |
| Post-operative infection (edema or pus at the post-operative site) |
3 weeks, 6 weeks, 3 months, 6 months |
| Post-operative nerve paraesthesia (using two-point discrimination) |
3 weeks, 6 weeks, 3 months, 6 months |
| Hardware fracture |
3 weeks, 6 weeks, 3 months, 6 months |
| Hardware loosening |
3 weeks, 6 weeks, 3 months, 6 months |
| Time taken for the procedure |
after exposure of fracture site till completion of osteosynthesis i.e intra-operatively |
| Pain score (Visual analogue scale: VAS score) |
3 weeks, 6 weeks, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/02/2022 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Though literature demonstrates wide variety of internal fixation choices for anterior mandibular fractures, however, there is no sufficient evidence about the superiority of HBS screw over the standard miniplate fixation. Also, none of the studies had similar dimensions of the HBS screw. Also, none of the studies defined the length of the proximal and distal threads of HBS screws. Furthermore, some of the studies did not mention whether they used single or double HBS screws in anterior mandible fixation; and other studies either utilized one or two HBS screws. Also, the number of the holes in minplate fixation was not defined in many studies. None of the studies in literature could be found comparing two different dimensions of HBS screws in view of their outcomes. Hence this study aims to eliminate all the limitations found in literature, along with evaluating and standardizing the most suitable dimensions of the HBS screw, along with standardizing the manufacturer. Furthermore, it aims to compare the outcomes with the standard miniplate fixation. |