| CTRI Number |
CTRI/2025/11/097279 [Registered on: 12/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the effects of placental extract on the healing process following extraction. |
|
Scientific Title of Study
|
Evaluating role of placental extract in extraction socket healing using chitosan microspheres as delivery vehicle |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iniya Shree |
| Designation |
Post Graduate Student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital
Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9488627387 |
| Fax |
|
| Email |
driniyashree@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Jayanthi.L |
| Designation |
Assistant Professor |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital
Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9488627387 |
| Fax |
|
| Email |
drjayanthishyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Iniya Shree |
| Designation |
Post Graduate Student |
| Affiliation |
Meenakshi Ammal Dental College and Hospital |
| Address |
Meenakshi Ammal Dental College and Hospital
Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9488627387 |
| Fax |
|
| Email |
driniyashree@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi Ammal Dental College and Hospital |
|
|
Primary Sponsor
|
| Name |
Iniya Shree |
| Address |
Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Iniya Shree |
Meenakshi Ammal Dental College and Hospital |
Meenakshi Ammal Dental College and Hospital Alapakkam Main Road, Janaki Nagar, Maduravoyal, Chennai
Chennai
TAMIL NADU
600095
India
Chennai
TAMIL NADU |
9488627387
driniyashree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committec, Meenakshi Ammal Dental Colege and Hospital, Maduravoyal, Chennai-95. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental Extraction |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
chitosan Placental extract microspheres (Chi-plac) |
The placenta serves as a natural reservoir of biologically active compounds—including hormones, proteins, peptides, growth factors, nucleic acids, glycosaminoglycans (GAGs), and polydeoxyribonucleotides (PDRNs)—all of which are essential for fetal growth and development. Owing to this rich composition, placental extracts have demonstrated notable healing potential and have been widely used over the years for various conditions such as ulcers, burn injuries, chronic wounds, pressure ulcers, and as post-surgical dressings. Chitosan, a naturally occurring polysaccharide derived from insect exoskeletons, crustacean shells, and fungal cell walls, is also known as soluble chitin. It is non-toxic, biocompatible, biodegradable, and its degradation products are harmless and fully absorbed by living organisms. These properties make chitosan an excellent carrier medium for drug delivery systems. In our study, we utilized the unique properties of chitosan to incorporate placental extract, creating a stable formulation aimed at enhancing wound healing. |
| Comparator Agent |
Plain Chitosan |
Chitosan, a naturally occurring polysaccharide derived from insect exoskeletons, crustacean shells, and fungal cell walls, is also known as soluble chitin. It is non-toxic, biocompatible, biodegradable, and its degradation products are harmless and fully absorbed by living organisms. These properties make chitosan an excellent carrier medium for drug delivery systems |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
It will be conducted on 10 patients undergoing bilateral mandibular third molar/premolar removal at the Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital. Only medically fit patients classified as ASA I or II, and consenting to participate will be included. |
|
| ExclusionCriteria |
| Details |
Patients with habits such as smoking or alcohol use, systemic illnesses contraindicating extraction, pregnancy (first and third trimester), bleeding disorders, malignancies, those on oral contraceptives, or patients showing allergic response to placentrex on prick testing will be excluded. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of pain, swelling, mucosal healing, and bone regeneration following placement of chitosan–placental extract microspheres in extraction sockets compared to control. |
Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, 1 month, and 3 months post-extraction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/12/2025 |
| 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="0"
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
|
Introduction: Following tooth extraction, the socket undergoes a series of remodeling and regenerative processes to restore the normal continuity of the bone. However, in certain cases, this complex regenerative process may be delayed or incomplete. The placenta serves as a natural reservoir of biologically active compounds—including hormones, proteins, peptides, growth factors, nucleic acids, glycosaminoglycans (GAGs), and polydeoxyribonucleotides (PDRNs)—all of which are essential for fetal growth and development. Owing to this rich composition, placental extracts have demonstrated notable healing potential and have been widely used over the years for various conditions such as ulcers, burn injuries, chronic wounds, pressure ulcers, and as post-surgical dressings. Chitosan, a naturally occurring polysaccharide derived from insect exoskeletons, crustacean shells, and fungal cell walls, is also known as soluble chitin. It is non-toxic, biocompatible, biodegradable, and its degradation products are harmless and fully absorbed by living organisms. These properties make chitosan an excellent carrier medium for drug delivery systems. In our study, we utilized the unique properties of chitosan to incorporate placental extract, creating a stable formulation aimed at enhancing wound healing. To further evaluate this product, we assessed its drug release profile, particle size distribution, cytotoxicity, and performed scanning electron microscopy (SEM) analysis.Objectives of the project: - To develop biocompatible chitosan microspheres incorporating human aqueous placental extract (APE) for localized regenerative therapy in dental extraction sockets.
- To achieve sustained and controlled release of placental bioactive molecules, preserving their therapeutic activity over time.
- To enhance tissue healing and regeneration in dental extraction sites through a synergistic combination of chitosan and placental extract.
- To design a microsphere system free of cytotoxic crosslinkers, ensuring safe local application in the oral cavity.
To provide a tailored, clinically translatable delivery platform that overcomes limitations of current synthetic and natural polymer systems for improved bone and soft tissue healing in extraction sockets. |