FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091143 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of two treatments for dry Socket: Platelet-Rich Fibrin vs Zinc Oxide Eugenol 
Scientific Title of Study   COMPREHENSIVE EVALUATION OF PLATELET-RICH FIBRIN AND ZINC OXIDE EUGENOL IN MANAGEMENT OF ALVEOLAR OSTEITIS AT TWO CENTRES : A 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 SREEHARI K N 
Designation  POST GRADUATE STUDENT 
Affiliation  KVG DENTAL COLLEGE AND HOSPITAL SULLIA 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KVG DENTAL COLLEGE AND HOSPITAL SULLIA DAKSHINA KANNADA KARNATAKA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7907921605  
Fax    
Email  sreeharikodakkad269n@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SUMANTH UNKALKAR 
Designation  READER 
Affiliation  KVG DENTAL COLLEGE AND HOSPITAL SULLIA 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KVG DENTAL COLLEGE AND HOSPITAL SULLIA DAKSHINA KANNADA KARNATAKA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9036125346  
Fax    
Email  Drsumanth05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SREEHARI K N 
Designation  POST GRADUATE STUDENT 
Affiliation  KVG DENTAL COLLEGE AND HOSPITAL SULLIA 
Address  DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY KVG DENTAL COLLEGE AND HOSPITAL SULLIA DAKSHINA KANNADA KARNATAKA

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7907921605  
Fax    
Email  sreeharikodakkad269n@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR SREEHARI K N  
Address  DEPT. OF ORAL AND MAXILLOFACIAL SURGERY K.V.G DENTAL COLLEGE,SULLIA, DK, KARNATAKA- 574327 
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SREEHARI K N  Department of Oral and Maxillofacial Surgery, KVG Dental College & Hospital satellite centre Sullia  Department of Oral and Maxillofacial Surgery, KVG Dental College & Hospital satellite centre Sullia
Dakshina Kannada
KARNATAKA 
7907921605

sreeharikodakkad269n@gmail.com 
DR SREEHARI K N  KVG DENTAL COLLEGE AND HOSPITAL SULLIA  DEPARTMENT OF ORAL & MAXILLOFACIAL SURGERY, KVG DENTAL COLLEGE & HOSPITAL, KURUNJIBHAG, SULLIA PIN CODE: 574327
Dakshina Kannada
KARNATAKA 
7907921605

sreeharikodakkad269n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE KVG DENTAL COLLEGE AND HOSPITAL SULLIA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ALVEOLAR OSTEITIS 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COMPREHENSIVE EVALUATION OF PLATELET-RICH FIBRIN AND ZINC OXIDE EUGENOL IN MANAGEMENT OF ALVEOLAR OSTEITIS  PRF or ZOE will be placed in socket of patients with informed consent. Patients are recalled on the 1st, 3rd, 5th and 7th days, and pain, healing, and complications (if any) are evaluated and recorded 
Comparator Agent  PRF or ZOE  COMPREHENSIVE EVALUATION OF PLATELET-RICH FIBRIN AND ZINC OXIDE EUGENOL IN MANAGEMENT OF ALVEOLAR OSTEITIS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient age group ranging between 18 and 70 years
Both males and females diagnosed with alveolar osteitis.  
 
ExclusionCriteria 
Details  Patients who are allergic to ZOE and/or to other medications prescribed in the study
Patients below the age of 18 years and above the age of 70 years
Pregnant patients
Medically compromised patients, for example, diabetes in which healing is delayed
Patients having fractured root or foreign body in the dry socket. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of PRF and ZOE
in treatment of Alveolar osteitis by measuring pain reduction and healing of wound as clinical outcomes 
at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Complications such as delayed healing, abscess, osteomyelitis, space infections, &
foreign body reactions are noted. Sockets that remained unhealed even after the 10th
day are considered to be delayed healing. 
4 weeks 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/08/2025 
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="1"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Alveolar osteitis (AO), or "dry socket," is a painful condition of jaws that typically begins one to three days following the extraction of teeth. Once other causes of pain in the region are eliminated, Blum defined dry socket as "postoperative pain in and around the extraction site, which increases in severity at any time between 1 and 3 days after the extraction, accompanied by a partially or completely disintegrated blood clot within the alveolar socket, with or without halitosis". Crawford used the term "dry socket" in 1896 to describe the condition. This condition has also been called othernames, such as fibrinolytic alveolitis, alveolitis sicca dolorosa, postoperative alveolitis, alveolalgia, septic socket, necrotic socket, localized osteomyelitis, and delayed extraction wound healing. Clinical manifestations and symptoms of AO are severe, often radiating, throbbing pain within and around the extraction socket, a clot-less extraction socket that can even appear totally empty or partially filled with a grayish-yellow membrane of necrotic tissue, foul mouth odor, offensive taste, gingival edema, and localized lymphadenitis. Oral anaerobic bacteria, anatomical site,traumatic removals, overuse of irrigation solution at the surgical area, curettage of the extraction socket, mechanical removal of the blood clot, fibrinolysis of the blood clot, smoking, oral contraceptives, immunosuppression, female sex, and vasoconstrictors are some of the possible etiologies of dry socket. Alveolar lavage, medicated dressings, analgesics, antibiotics, topical anesthetics, and obtundent, and their combinations, are the usual methods applied in the management of AO. Dry sockets can be treated with many medicines such as iodoform, zinc oxide eugenol (ZOE), acemannan, guaiacol, chlorobutanol, neocone, alvogyl, butylparaminobenzoate, and chlorhexidine. For the purpose of treating dry sockets, the sedative, antimicrobial, and obtundent properties of ZOE have been utilized in the form of intra-alveolar dressings. Platelet-rich fibrin (PRF) is a second-generation platelet concentrate that was introduced by Choukroun et al in 2001. PRF is a tetra meric polymer gel that has the ability to accelerate the formation of new bone and physiologic healing of wounds by injecting circulating stem cells, platelets, leukocytes, cytokines, and growth factors in its matrix. It has been postulated that application of PRF may accelerate the healing process of the extraction socket, which will reduce postoperative pain wherein PRF serves as a scaffold for enhanced healing. In 2021, Reeshma S et al. compared efficacy of platelet-rich fibrin with zinc oxide eugenol in the relief of pain in alveolar osteitis published in Health Science Reports and resulted in PRF gives greater pain relief than ZOE but study lacks evaluation of wound healing. Therefore the current study intended to assess efficacy of PRF and ZOE in treatment of Alveolar osteitis by measuring pain reduction and healing of wound as clinical outcomes.

 
Close