| CTRI Number |
CTRI/2026/01/100174 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Socket Preservation After Molar Extraction: Comparing Bone Graft and Platelet rich fibrin in Adult Patients" |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Demineralised Bone
Matrix With Resorbable Collagen Membrane And Platelet Rich
Fibrin After Extraction Of Mandibular Molar For Socket
Preservation. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kshitija dhoke |
| Designation |
2nd year MDS post graduate student |
| Affiliation |
Nair hospital dental college |
| Address |
maxillofacial surgery department 1st floor OPD building nair hospital dental college dr AL nair marg mumbai central mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
07083506144 |
| Fax |
|
| Email |
kshitijadhoke20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Snehal Ingole |
| Designation |
Associate professor |
| Affiliation |
Nair hospital dental college |
| Address |
maxillofacial surgery department 1st floor OPD building nair hospital dental college 55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
07083506144 |
| Fax |
|
| Email |
ingole.snehal@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. kshitija dhoke |
| Designation |
2nd year MDS post graduate student |
| Affiliation |
Nair hospital dental college |
| Address |
nair hospital dental college 55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
07083506144 |
| Fax |
|
| Email |
kshitijadhoke20@gmail.com |
|
|
Source of Monetary or Material Support
|
| nair hospital dental college |
|
|
Primary Sponsor
|
| Name |
nair hopsital dental college |
| Address |
55, Dr. AL Nair marg in front of maratha mandir mumbai central mumbai |
| Type of Sponsor |
Government medical college |
|
|
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 |
| kshitija dhoke |
Nair Hospital Dental College |
maxillofacial surgery department 1st floor OPD building 55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
07083506144
kshitijadhoke20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee nair hospital dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
carious mandibular molar |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
osseograft and GTR membrane |
osseograft is demineralized bone graft which is place din extraction socket and over which GTR membrane which is collagen membrane is placed and suturing is done |
| Intervention |
platelet rich fibrin |
3ml of platelet rich fibrin is placed in extraction socket and wait for 4 months for new bone formation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1) Individual Falling In 18-39 years And 40-60 years Age Groups
2) Individual In Need of Mandibular Molar Extraction.
3) Healthy Individual Without Any Co- Morbidity |
|
| ExclusionCriteria |
| Details |
1) Individuals With Known H/O Of Thyroid Disorder, Renal
Disease, Diabetes Mellitus, Uncontrolled Hypertension,
Under Antiplatelets & Anticoagulant Therapy, Bronchial
Asthma.
2) Pregnant Females |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare and Evaluate of Efficacy of Demineralised Bone
Matrix with Resorbable Collagen Membrane and Platelet Rich
Fibrin for Preservation of Alveolar Socket after Extracti on of
Mandibular Molars. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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 - NO
|
|
Brief Summary
|
This study includes patients (18–60 years) undergoing mandibular molar extraction at the Oral and Maxillofacial Surgery Department. After obtaining informed consent and basic blood investigations (CBC), patients will be randomly assigned to two groups: -
Group A: Socket preservation using Demineralised Dentin Matrix (Osseograft) with a Resorbable Collagen Membrane. -
Group B: Socket preservation using Platelet-Rich Fibrin (PRF) prepared from autologous blood by centrifugation at 3000 rpm for 10 minutes. Each group will be further divided into subgroups based on age (18–39 and 40–60). All extractions will be performed under local anesthesia using standard aseptic protocols by a single operator. After placement of materials, resorbable sutures will be placed. Patients will receive standard post-extraction medications (Amoxicillin 500 mg and Diclopara TDS for 5 days). CBCT scans will be taken before extraction and at 4 months post-operatively. Healing will be evaluated at 7 days and 4 months post-op. Parameters assessed include: -
Alveolar bone height and width (using CBCT measurements), -
Bone density via gray scale values (DICOM viewer), -
Clinical healing (pain, swelling, infection), -
Comparison of socket healing between materials. |