Safety and Efficacy of Resveratrol in Healing of Maxillofacial Fractures: A Randomized Control Study

AIM AND OBJECTIVES

AIM:

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

OBJECTIVES:

Primary

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

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

Secondary

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

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

RESEARCHQUESTION:

Is the procedureof 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 ofDentistry (Oral and Maxillofacial Surgery) and Department of Biochemistry, All India Institute of Medical Sciences, Jodhpur.

5. Materials

1.    ELISA kit for osteocalcinwith 98 wells

2.    Tablet Resveratrol 1g

6. Methodology

A randomizedcontrol study will be conducted in the Department of Dentistry AIIMS Jodhpur incollaboration with Department of Biochemistry.

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

Group A controlgroup (20 patients)

Open reductionand Internal fixation followed by administration of Placebo.

Group B – studygroup (20 patients)

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

7. Sampleselection criteria

Inclusioncriteria

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

2.    ASA I or II

Exclusioncriteria

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.     BITEFORCE:

Maximumvoluntary bite force is recorded in right and left molar region and mean willbe 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 forcegenerated will be converted in to numerical values.

2.BLOOD BONE MARKERS

Blood sampleswill be taken from patients from both the groups and evaluated for SerumOsteocalcin and Alkaline Phosphatase at Preoperatively, 4th and 12thweek postoperatively.