Safety and Efficacy of Drug Resveratrol in Healing of Maxillofacial Fractures

Phase 4

Not yet recruiting

• Conditions: Fractures of other specified skulland facial bones,

• Registration Number: CTRI/2021/10/037437
• Lead Sponsor: ALL INDIA INSTITUTE OF MEDICAL SCIENCES

Brief Summary

**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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-10-20
• Study Start: 2021-10-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Evaluation of Bite force	Pre-operatively

Trial Locations

Locations (1)

All India institute of medical sciences; 🇮🇳 Jodhpur, RAJASTHAN, India

All India institute of medical sciences

🇮🇳Jodhpur, RAJASTHAN, India

DR ANKITA CHUGH

Principal investigator

08003996891

ankitamody@gmail.com