| 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
|
|
|
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
|
|
|
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
|
|
|
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. |