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CTRI Number  CTRI/2026/01/102124 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 13/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Use of a Silver-Containing Absorbable Sponge to Reduce Pain, Bleeding, and Infection After Tooth Extraction compared to standard dental extraction protocol 
Scientific Title of Study   ROLE OF COLLOIDAL SILVER INFUSED GELATIN SPONGE IN REDUCTION OF POST OPERATIVE COMPLICATIONS FOLLOWING DENTAL EXTRACTIONS : A SPLIT MOUTH STUDY 
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 Karanpartap Singh Sidhu 
Designation  Post Graduate Student 
Affiliation  Yenepoya Dental College 
Address  Department of Oral and Maxillofacial surgery Yenepoya Dental College Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9256900097  
Fax    
Email  kaypeesidhu97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arvind Rao H T 
Designation  Additional Professor  
Affiliation  Yenepoya Dental College 
Address  Department of Oral and Maxillofacial surgery Yenepoya Dental College Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448142508  
Fax    
Email  arvind_raoht@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arvind Rao H T 
Designation  Additional Professor  
Affiliation  Yenepoya Dental College 
Address  Department of Oral and Maxillofacial surgery Yenepoya Dental College Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9448142508  
Fax    
Email  arvind_raoht@rediffmail.com  
 
Source of Monetary or Material Support  
Aegis life sciences 215 216 Mahagujarat Industrial estate Phase 3 Changodar Moraiya Sanand Ahmedabad 382213 Gujarat India 
 
Primary Sponsor  
Name  Yenepoya Dental College  
Address  Yenepoya Dental College Yenepoya Deemed to be University Mangalore Karnataka 575018 
Type of Sponsor  Other [Private 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 Karanpartap Singh Sidhu  YENEPOYA DENTAL COLLEGE  Department of Oral and Maxillofacial surgery DEPARTMENT - 4
Dakshina Kannada
KARNATAKA 		 9256900097

kaypeesidhu97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YENEPOYA ETHICS COMMITTEE 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with grossly decayed or prophylactic removal of teeth indicated for extraction without any co-morbidities and systemic diseases. 
Patients  (1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COLLOIDAL SILVER INFUSED GELATIN SPONGE   Following dental extraction, a sterile colloidal silver–infused gelatin sponge is placed intra-socket immediately after tooth removal. The sponge is adapted to fill the extraction socket and left in situ to act as a local hemostatic and antimicrobial dressing. No routine postoperative antibiotics are prescribed.Closure done by 3-0 silk suture. Postoperative pain management is limited to rescue analgesics given only if required. 
Comparator Agent  Standard dental extraction   Dental extraction is performed using standard surgical technique without placement of any intra-socket material.Closure with 3-0 silk suture. Postoperative management includes routine systemic antibiotics and analgesics as per standard institutional protocol. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Participants requiring bilateral extraction of molars or premolars
2 Subjects in Age group between 18 to 55 years
3 Individuals under ASA I category
4 Willing to participate and provide informed consent

 
 
ExclusionCriteria 
Details  1 Allergy to silver or medications used in study
2 Subjects with Acute oral infections
3 Smokers and alcohol consumers
4 Pregnant or lactating women
5 Systemic conditions affecting healing (eg Diabetes Mellitus)
6 Immunocompromised patients
7 Unwilling to participate 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is the incidence of postoperative complications at the extraction site, including bleeding, pain, infection, and delayed wound healing, following dental extraction.  The primary outcome will be assessed at baseline (immediately after tooth extraction) and during the postoperative follow-up period on postoperative day 1, postoperative day 3, postoperative day 7, and at 4 weeks after extraction. 
 
Secondary Outcome  
Outcome  TimePoints 
Total number of rescue analgesics tablets paracetamol 500mg consumed by the participant following study side extraction on post operative days.  1st 3rd and 7th postoperative day 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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   N/A 
Date of First Enrollment (India)   05/02/2026 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Dental extraction is a common procedure that may be associated with post operative complications such as pain bleeding swelling and delayed wound healing. The oral cavity is constantly exposed to saliva and bacteria which can interfere with clot stability and healing of the extraction socket. Effective local measures are required to control bleeding reduce infection risk and promote wound healing.

Colloidal silver infused gelatin sponge is a locally acting material with hemostatic and antimicrobial properties. Gelatin sponge helps in clot formation and stabilization while colloidal silver reduces microbial load at the extraction site without the need for systemic antibiotics.

This study is designed as a randomized split mouth interventional study to evaluate the effectiveness of colloidal silver infused gelatin sponge in reducing post operative complications following dental extractions. Patients requiring bilateral extraction of molars or premolars will be included in the study. One extraction site will receive colloidal silver infused gelatin sponge while the contralateral site will serve as control without any intra socket material.

Post operative medication protocol will differ between the study and control sites with the study side receiving rescue analgesics only while the control side will receive standard post extraction antibiotics and analgesics.

Post operative outcomes including soft tissue healing pain bleeding swelling and number of rescue analgesic medications consumed will be assessed at predefined time points. The results of this study may help in improving post extraction wound management and reducing reliance on systemic antibiotics in routine dental practice.
 
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