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CTRI Number  CTRI/2025/09/094339 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 05/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Effect of Salmon Calcitonin Nasal Spray on Bone Healing After Wisdom Tooth Removal 
Scientific Title of Study   Evaluation of the Efficacy of Intranasal Salmon Calcitonin on Bone Healing Following Surgical Removal of Impacted Mandibular Third Molars — A Randomized Controlled Clinical 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  Harni N 
Designation  Post Graduate 
Affiliation  Madha Dental College 
Address  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600030
India 
Phone  9791048562  
Fax    
Email  n.harni001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Satheesh C 
Designation  Professor 
Affiliation  Madha Dental College 
Address  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600030
India 
Phone  9791048562  
Fax  9791048562  
Email  ch.satheesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Harni N 
Designation  Post Graduate 
Affiliation  Madha Dental College 
Address  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU
600030
India 
Phone  9791048562  
Fax    
Email  n.harni001@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Harni N 
Address  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069 
Type of Sponsor  Other [Dental 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 Harni N  Madha Dental College  Somangalam Main Rd, Madha Nagar, Kundrathur, Chennai, Sikkarayapuram, Tamil Nadu 600069
Chennai
TAMIL NADU 		 7273901234

n.harni001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical committee clearance madha dental college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K011||Impacted teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcitonin Nasal Spray  Observing bone healing and analgesic effect of calcitonin hormone after third molar removal surgery for a total period of three months. 
Comparator Agent  Comparing with normal bone healing.  Comparing with normal bone healing after third molar removal surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with impacted mandibular third molar.
Pederson difficulty index score of 6 and above.
Patients in the age group between 18 to 40 years
ASA-1 category
 
 
ExclusionCriteria 
Details  Patients with seafood alleregy
Patients with Peri apical pathology
ASA-2,3,4,5 and 6 CATEGORIES
Patient with any previous history of cardiomyopathy
Patient with any known history of Thyroid dysfunction.
Patient undergoing therapies with bisphosphonates and immunosuppressants.
Patient with any known history of osteoporosis or pathologic fractures.
Asthmatic patients.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
A total of 100 patients will be randomly divided into two groups: Group I will receive intranasal salmon calcitonin along with standard postoperative care, while Group II will receive only standard care.  Postoperative pain will be assessed using the Visual Analog Scale on days 1, 7, 14, 21, and 30. 
 
Secondary Outcome  
Outcome  TimePoints 
bone healing will be evaluated by radiographic assessment of bone density at the extraction site immediately after surgery.  Assessed at 4 weeks, and at 12 weeks. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   20/09/2025 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This randomized controlled study will evaluate the efficacy of salmon calcitonin nasal spray on bone healing and postoperative pain following surgical removal of impacted third molar. A total of 100 patients will be randomly divided into two groups : Group 1 will receive intranasal salmon calcitonin along with standard postoperative care, while group 2 will receive standard care. Post op pain will be assessed using Visual Analogue Scale VAS on day 1,7,14,21 and 30, and bone healing will be evaluated by radiographic assessment of bone density at extraction site immediately after surgery, at 4 weeks and 12 weeks. 
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