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CTRI Number  CTRI/2026/01/100924 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 09/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Stem Cell Therapy
Surgical/Anesthesia
Preventive
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing Medicines to Reduce Pain, Swelling, and Discomfort After Wisdom Tooth Surgery 
Scientific Title of Study   Comparative evaluation of dexamethasone, vitamin-c and platelet growth factors in postoperative sequelae of impacted third molar: Randomised 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  DR AMBHUJA AGRAWAL 
Designation  Oral and Maxillofacial Surgery Resident 
Affiliation  Saraswati Dental College and Hospital 
Address  Saraswati Dental College and Hospital 233, tiwariganj, Faizabad road Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone  8982983180  
Fax    
Email  ambhuja5499@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR IRFAN UL HASSAN HAJI 
Designation  Professor 
Affiliation  SARASWATI DENTAL COLLEGE 
Address  room no. 5, Oral and Maxillofacial Surgery,Saraswati Dental College and Hospital 233, tiwariganj, Faizabad road Lucknow 226028

Lucknow
UTTAR PRADESH
226028
India 
Phone  9596477410  
Fax    
Email  dr.irfanhaji@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR AMBHUJA AGRAWAL 
Designation  Oral and Maxillofacial Surgery Resident 
Affiliation  Saraswati Dental College and Hospital 
Address  room no. 5, Oral and Maxillofacial Surgery,Saraswati Dental College and Hospital 233, tiwariganj, Faizabad road Lucknow

Lucknow
UTTAR PRADESH
226028
India 
Phone  8982983180  
Fax    
Email  ambhuja5499@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  SARASWATI DENTAL COLLEGE AND HOSPITAL 
Address  Saraswati Dental College and Hospital 233, tiwariganj, Faizabad road Lucknow 226028 
Type of Sponsor  Private 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 AMBHUJA AGRAWAL  Saraswati Dental College and Hospital  Room no. 5, ground floor Department of Oral and Maxillofacial Surgery , Saraswati Dental College and Hospital 233, tiwariganj, Faizabad road Lucknow 226028
Lucknow
UTTAR PRADESH 		 08982983180

ambhuja5499@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Buman Ethics Committee   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 
Comparator Agent  Conventional extraction socket management (Gelfoam alone / no local medicament)  total 14 Postoperative days. Patient is followed up on day 3, 1 week and 2 weeks 
Intervention  Gelfoam impregnated with concentrated growth factors, vitamin C, and dexamethasone  total 14 Postoperative days. Patient is followed up on day 3, 1 week and 2 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients categorized under ASA-I and ASA-II health status

Mesioangular, Position B, Level 2 mandibular third molar impaction

 
 
ExclusionCriteria 
Details  Pregnant & Lactating mother
Patient having active infection in or around surgical site
Patients on long-term steroid therapy
Patients not willing to participate in the study
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain assessment (VAS Scale)
2.Swelling evaluation (Facial measurements)

3.Mouth opening (Interincisal width)
 		 Day 3, 1 week, and 2 weeks postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic consumption  Day 3, 1 week, and 2 weeks postoperatively 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (ambhuja5499@gmail.com).

  6. For how long will this data be available start date provided 08-12-2027 and end date provided 08-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study evaluates postoperative sequelae following surgical removal of impacted mandibular third molars using Gelfoam impregnated with concentrated growth factors, vitamin C, and dexamethasone placed in the extraction socket. Concentrated growth factors promote wound healing and tissue regeneration, vitamin C enhances collagen synthesis and provides antioxidant support, while dexamethasone helps in controlling postoperative inflammation. Postoperative pain, facial swelling, and trismus were assessed at predetermined intervals to evaluate clinical outcomes. The study aims to determine the effectiveness of this combined local application in reducing postoperative complications and improving patient recovery and comfort following impacted third molar surgery. 
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