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CTRI Number  CTRI/2021/10/037437 [Registered on: 21/10/2021] Trial Registered Prospectively
Last Modified On: 20/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Safety and Efficacy of Drug Resveratrol in Healing of Maxillofacial Fractures 
Scientific Title of Study   Safety and Efficacy of Resveratrol in Healing of Maxillofacial Fractures: A Randomized Control 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 ANKITA CHUGH 
Designation  Additional Professor  
Affiliation  AIIMS Jodhpur 
Address  Department of Dentistry AIIMS Jodhpur Basni Industrial area Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996891   
Fax    
Email  ankitamody@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ANKITA CHUGH 
Designation  Additional Professor  
Affiliation  AIIMS Jodhpur 
Address  Department of Dentistry AIIMS Jodhpur Basni Industrial Area

Jodhpur
RAJASTHAN
342005
India 
Phone  08003996891   
Fax    
Email  ankitamody@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SHIVKUMAR CHOPANE  
Designation  Junior Resident 
Affiliation  AIIMS Jodhpur 
Address  204, Department of Dentistry, AIIMS Jodhpur Basni Industrial Area, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9765931438  
Fax    
Email  shivkumarchopane@gmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,JODHPUR  
 
Primary Sponsor  
Name  ALL INDIA INSTITUTE OF MEDICAL SCIENCES  
Address  Basni Industrial Area, Phase 2,Jodhpur-342005  
Type of Sponsor  Government medical college 
 
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 
DR ANKITA CHUGH  All India institute of medical sciences   Room No 213, Department of Dentistry, Block A, Second Floor, OPD Block
Jodhpur
RAJASTHAN 		 08003996891

ankitamody@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S028||Fractures of other specified skulland facial bones,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  group A-Tab Resveratrol 500mg BD  Open reduction and internal fixation with administration of Tab Resveratrol 500mg BD for 1 month 
Comparator Agent  group B-Placebo group.  Open reduction and Internal fixation followed by administration of Placebo. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients between the age of 20-60 years with maxillofacial fractures
2. ASA I or II
 
 
ExclusionCriteria 
Details  1. Age <20 years and >60 years
2. Pregnant or lactating females
3. Hypercalcemia, Paget’s disease or any other bone disorder
4. Malignant tumours
5. Patients earlier having radiation treatment.
6. Patients on Vitamin D therapy or any other bone medications
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the safety and efficacy of resveratrol on healing of maxillofacial fractures.  Pre-operatively
1st week post-operatively
4th week post-operatively
8th week post-operatively
12th week post-operatively 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Bite force  Pre-operatively
1st week postoperatively
4th week postoperatively
8th week postoperatively
12th week postoperatively 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   31/10/2021 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

AIM AND OBJECTIVES

AIM:

To evaluate and compare the safety and efficacy of resveratrol on healing of maxillofacial fractures.

OBJECTIVES:

                   Primary

·       To compare the levels of serum Osteocalcin and Alkaline phosphatase between Resveratrol and control group in maxillofacial trauma cases

·       To correlate the findings with bite force measurements in both the groups

                   Secondary

·       To evaluate any adverse outcomes like infection, delayed union and non-union.

·       To evaluate the incidence of drug related adverse events in experimental group.

RESEARCH QUESTION:

Is the procedure of bone healing fastened on administration of Resveratrol?

NULL HYPOTHESIS:

Fracture healing is same with or without the use of Resveratrol.

MATERIALS AND METHODS

1. Study Design:        Randomized control trial.     

2. Sample size:           40 patients (20 in each group)

3. Duration:               18 months

4. Site of study:         The study will be carried out in the Department of Dentistry (Oral and Maxillofacial Surgery) and Department of Biochemistry, All India Institute of Medical Sciences, Jodhpur.

5. Materials

1.     ELISA kit for osteocalcin with 98 wells

2.     Tablet Resveratrol 1g

6. Methodology

A randomized control study will be conducted in the Department of Dentistry AIIMS Jodhpur in collaboration with Department of Biochemistry.

A sample of 40 patients with maxillofacial fracture will be randomly divided into 2 groups

Group A control group (20 patients)

Open reduction and Internal fixation followed by administration of Placebo.

Group B – study group (20 patients)

Open reduction and internal fixation with administration of Tab Resveratrol 500mg BD for 1 month.

7. Sample selection criteria

Inclusion criteria

1.     Patients between the age of 20-60 years with maxillofacial fractures

2.     ASA I or II

Exclusion criteria

  1. Age <20 years and >60 years
  2. Pregnant or lactating females
  3. Hypercalcemia, Paget’s disease or any other bone disorder
  4. Malignant tumours
  5. Patients earlier having radiation treatment.
  6. Patients on Vitamin D therapy or any other bone medications

8.  Parameter Evaluation:

1.      BITE FORCE:

Maximum voluntary bite force is recorded in right and left molar region and mean will be calculated in all patients of both the groups at preoperatively, 1st, 4th, 8th , 12th week using Flexi force sensor. It act as a force sensing resistor in an electrical circuit. The force generated will be converted in to numerical values.

2.BLOOD BONE MARKERS

Blood samples will be taken from patients from both the groups and evaluated for Serum Osteocalcin and Alkaline Phosphatase at Preoperatively, 4th and 12th week postoperatively.

 
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