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CTRI Number  CTRI/2025/04/084497 [Registered on: 09/04/2025] Trial Registered Prospectively
Last Modified On: 08/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "Evaluating Treatment outcomes in Lower Jaw Fractures at two sites with Mixed (combination of stiff and flexible) versus flexible fixation  
Scientific Title of Study   Evaluation of treatment outcomes in double mandibular fracture management with mixed versus non-rigid fixation – A randomized controlled 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  DrPavithraM 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS, Mangalagiri, Andhra Pradesh - 522503 
Address  Dr.Pavithra, Room number 444, Department of dentistry, fourth floor OPD block AIIMS, Old sanitorium, Near APSP Battalion, Mangalagiri - 522503, District Guntur Andhrapradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  7338971873  
Fax    
Email  m02jul024035@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jitendra Chawla 
Designation  Associate Professor 
Affiliation  AIIMS, Mangalagiri, Andhra Pradesh - 522503 
Address  Dr. Jitendra Chawla, Room number 444, Department of dentistry, fourth floor OPD block AIIMS, Old sanitorium, Near APSP Battalion, Mangalagiri - 522503, District Guntur Andhrapradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  7350521361  
Fax    
Email  jitendra.dental@aiimsmangalagiri.edu.in  
 
Details of Contact Person
Public Query  
Name  DrPavithraM 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS, Mangalagiri, Andhra Pradesh - 522503 
Address  Dr.Pavithra, Room number 444, Department of dentistry, fourth floor OPD block AIIMS, Old sanitorium, Near APSP Battalion, Mangalagiri - 522503, District Guntur Andhrapradesh 522503

Guntur
ANDHRA PRADESH
522503
India 
Phone  7338971873  
Fax    
Email  m02jul024035@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DrPavithraM 
Address  Room number 444 Department of dentistry, fourth floor OPD block AIIMS, old sanitorium, near APSP battalion Mangalagiri 522503 District Guntur, Andhra pradesh  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrPavithraM  AIIMS Mangalagiri  All India Institute of Medical Sciences, Old TB Sanitorium, Near APSP battalion, Mangalagiri - 522503 Dist-Guntur, Andhrapradesh
Guntur
ANDHRA PRADESH 		 7338971873

m02jul024035@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE,(ECR/1416/Inst/AP/2020), Government of India, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S026||Fracture of mandible,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1: Patients in this group will receive rigid fixation at one fracture site and non-rigid fixation at the other. (Mixed fixation)  1) Rigid Fixation - Defined as a method that prevents interfragmentary movement during functional activities. In this study, rigid fixation includes the following methods: a. Two 2-mm non-compression locking or nonlocking miniplates b. A three-dimensional geometric plate. c. A reconstruction plate (non-locking 2.7 mm or locking 2.4 mm thick) d. Two 2.4-mm lag screws e. A single plate with a minimum thickness of 1.25 mm with at least three screws on either side of the fracture line 2) Nonrigid Fixation - Defined as a functionally stable fixation that allows micromovement between the bone fragments. In this study, nonrigid fixation includes the following methods: a. A conventional 2 mm locking or non-locking 4-hole miniplate with a gap 
Comparator Agent  Group 2: Patients in this group will receive non-rigid fixation at both fracture sites. (Non-rigid fixation)  Nonrigid Fixation - Defined as a functionally stable fixation that allows micromovement between the bone fragments. In this study, nonrigid fixation includes the following methods: a. A conventional 2 mm locking or non-locking 4-hole miniplate with a gap 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1) Patients with double mandibular fractures (ipsilateral or contralateral)
2) Patients with permanent dentition and a sufficient number of teeth to evaluate occlusion.
3) Patients or their guardians who are willing to provide written informed consent for the surgical procedure and follow-up.
 
 
ExclusionCriteria 
Details  1) Comminuted mandibular fractures.
2) Fractures associated with active infection, non-union, malunion
3) Patients with ASA – IV / Immunocompromised patients
4) Patients with bone and metabolic disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the treatment outcomes of mixed fixation (Group-1) versus non-rigid fixation (Group-2) in patients with double mandibular fractures by evaluating preoperative and
postoperative bite force, occlusal alignment, hardware integrity, and wound healing status. 		 Bite force, occlusal alignment, hardware integrity, wound healing status - a day before surgery, after surgery day-1, after 6 weeks and 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objectives:
• To assess the radiographic alignment of fractures following fixation
• To assess the functional outcomes post-fixation, including bite force & occlusal stability.
• To evaluate the complications such as wound infection, wound dehiscence, hardware failure, & neurosensory disturbances following fixation
 		 Radiographic alignment of fractures - Preoperative, postoperative day 1, after 3 months
Bite force & occlusal stability, Wound infection, wound dehiscence, hardware failure, & neurosensory disturbance - a day before surgery, after surgery day-1, after 6 weeks & 3 months 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   19/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [m02jul024035@aiimsmangalagiri.edu.in].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 01-07-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Mandibular fractures are among the most common fractures of the facial skeleton, and the complex

anatomy of the mandible makes it susceptible to fractures at multiple sites, which can be on the same side or opposite. Over the past 40 years, mandibular

fractures have been treated using a technique called open reduction and internal fixation, which for a single fracture, can involve either a single miniplate

for non-rigid fixation or stronger reconstruction plates for rigid fixation. However, treating double mandibular fractures is challenging because the segment

in between two fractures lack support on either side resulting in rotational movement. Previous studies recommend different approaches for the management

of double mandibular fractures. Some suggest that a non-rigid fixation scheme can be used for both fractures, few suggest rigid fixation at least at one

fracture site and others recommend rigid fixation for both fractures. Despite the common occurrence of double mandibular fractures (22% to 52%), there is

limited knowledge regarding standardized, evidence-based, best fixation strategies. To address this gap, the present randomized controlled trial (RCT) will

compare the outcomes of non-rigid fixation alone and a combination of rigid and non-rigid internal fixation. This study aims to provide clearer guidelines

for the management of double mandibular fractures, ensuring better treatment outcomes and functional rehabilitation.

 
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