NAME OF PRINCIPAL INVESTIGATOR: Dr. Shailja Sinha

                                                                 Department of Pediatrics and Preventive Dentistry,

                                                                 ITS CDSR, MURADNAGAR,

                                                                 GHAZIABAD,

                                                                 UP- 201206

You are being invited to participate in a research study. 

Study Title: Comparative evaluation of sedative, anxiolytic and post-operative effects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8-year-old children - An ELISA-based study.

Invitation Paragraph: I would like to invite you to take part in a research study. Before you take part in this research study, we wish to explain the study to you and give you the chance to ask questions. Please read carefully the information provided here. If you agree to participate, please sign the informed consent form. 

Introduction: This information sheet describes the purpose, procedures, benefits, and discomforts of the study and your right to withdraw from the study at any point in time. 

Purpose: The purpose of this study is to compare sedative, anxiolytic, and post-operative effects of oral melatonin and nitrous oxide inhalation sedation in 5 to 8 year old children immediately after administration of local anesthesia for invasive dental procedures. 

Study Procedure: Your relevant clinical history will be recorded; a clinical examination will be conducted and findings will be noted. After taking written informed consent, the child will be administered Oral Melatonin Syrup or Nitrous Oxide Inhalation Sedation followed by the collection of his/her saliva for Salivary Cortisol assessment using an ELISA kit both before and immediately after the administration of IANB for primary mandibular molar indicated for extraction. The costs of the tests included in the protocol that form the routine radiological, and clinical investigations for the management of the patient, shall be borne by the patient. The cost of any additional investigations that are not part of routine diagnostics shall be borne by the Principal investigator/ Concerned Department/ Institute and should be free for the patient.

Risks: There are no expected risks of saliva collection. The expected risk of Oral Melatonin and Nitrous Oxide Inhalation Sedation includes minimal side effects such as mild dizziness and light-headedness. In case of any adverse event/ injuries, the participants shall be treated without any further charges for the adverse event. However, there shall be no financial compensation to the patient from the institution or Principal Investigator. 

Benefits: The information obtained shall be used to compare the effects of Oral Melatonin Syrup and Nitrous Oxide Sedation for the pharmacological behavior management of the child. This would help to increase our knowledge about the use of Oral Melatonin in Pediatric Dentistry.

Confidentiality: Records of your participation will be kept confidential. Any publication of data will not identify you by your name. By signing the consent form, you authorize the sharing of your study-related records with the regulatory authorities and the Institutional Ethical Committee.

Information regarding withdrawal: You have the right to withdraw yourself from the study at any time during the course of study without any prejudice to your or your family’s right to undergo future treatment at I.T.S. CDSR, Muradnagar.

There is no risk or complications associated with this study and in case of any doubt, you can contact at 7001573934.