| CTRI Number |
CTRI/2026/02/104335 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare healing after wisdom tooth removal using platelet concentrate (PRF) alone, PRF with gelfoam, and PRF with chitosan, using clinical examination and X-rays. |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic evaluation of PRF, PRF with Gelfoam and PRF with Chitosan in Mandibular Third Molar extraction socket healing - A Randomized Controlled 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 Akshaya Chavan |
| Designation |
Postgraduate student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738205590 |
| Fax |
|
| Email |
akshayachavan9360@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trupti Gandhewar |
| Designation |
Guide (Asso Prof, Dept of OMFS) |
| Affiliation |
Nair Hospital Dental College |
| Address |
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9819323729 |
| Fax |
|
| Email |
tgandhewar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshaya Chavan |
| Designation |
Postgraduate student |
| Affiliation |
Nair Hospital Dental College |
| Address |
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA
400008
India |
| Phone |
7738205590 |
| Fax |
|
| Email |
akshayachavan9360@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008 |
|
|
Primary Sponsor
|
| Name |
Nair Hospital Dental College |
| Address |
Nair Hospital Dental College, Mumbai Central, Mumbai , 400008 |
| 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 |
| Dr Akshaya Chavan |
Nair Hospital Dental College |
Department of Oral and Maxillofacial Surgery (room 107), Nair Hospital Dental College,
55, Dr Anandrao Nair Marg, in front of Maratha Mandir, Mumbai Central, Mumbai, Maharashtra 400008
Mumbai
MAHARASHTRA |
7738205590
akshayachavan9360@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Requiring surgical extraction of mandibular third molars |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PRF and Chitosan |
Randomization of participants into four groups will be carried out as per computer generated list of random numbers into group A, group B, group C and group D according to the intervention done to the extraction sockets after the extraction of indicated mandibular third molar. Group C: PRF Clot + Sterile Chitosan
Dose - 2ml PRF and 2ml Chitosan hydrogel
Frequency - Once (immediately after extraction)
Route - Both placed in extraction socket and sutures given
Duration - Follow up upto 3 months |
| Comparator Agent |
Natural Healing |
Randomization of participants into four groups will be carried out as per computer generated list of random numbers into group A, group B, group C and group D according to the intervention done to the extraction sockets after the extraction of indicated mandibular third molar. Group D: Natural healing (control)
No intervention done |
| Comparator Agent |
PRF and Gelfoam |
Randomization of participants into four groups will be carried out as per computer generated list of random numbers into group A, group B, group C and group D according to the intervention done to the extraction sockets after the extraction of indicated mandibular third molar. Group B: PRF Clot + Sterile Gelfoam
Dose - 2ml PRF
Frequency - Once (immediately after extraction)
Route - Placed followed by gelfoam in extraction socket and sutures given
Duration - Follow up upto 3 months |
| Intervention |
PRF Clot |
Randomization of participants into four groups will be carried out as per computer generated list of random numbers into group A, group B, group C and group D according to the intervention done to the extraction sockets after the extraction of indicated mandibular third molar.
Group A: PRF Clot alone
Dose - 2ml PRF
Frequency - Once (immediately after extraction)
Route - Placed in extraction socket and sutures given
Duration - Follow up upto 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18- 40 years.
2. Patients with good general health (ASA I).
3. Patients requiring surgical extraction of mandibular third molars. (impacted, carious or, periodontally involved lower third molars indicating need for extraction)
4. Patients with adequate mouth opening to permit standard surgical access.
5. Patients willing to participate.
6. Patients willing to provide written informed consent.
7. Patients willing to comply with the study protocol and follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic conditions affecting wound healing (uncontrolled diabetes mellitus, immunocompromised states).
2. Patients with bleeding disorders or platelet abnormalities.
3. Patients on anticoagulant or long-term steroid therapy.
4. Patients with active infection at the extraction site.
5. Smokers, alcoholics and tobacco users.
6. Pregnant or lactating women.
7. Patients allergic to local anesthetic agents.
8. Patients with previous surgery or pathology in the mandibular third molar region.
9. Mentally challenged patients or patients who are unable to communicate.
10. Patients unwilling to participate or unable to comply with follow-up visits.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Soft tissue healing (Modified Landry Healing Index)
2. Bone Regeneration (IOPA Xray using a Grid)
|
Day 3
Day 7
Day 14
1 month
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemostasis
2. Post Operative Pain (VAS score)
3. Swelling
4. Trismus (Maximum Inter Incisal Distance)
5. Incidence of Dry Socket
|
30 mins & 60 mins post extraction for hemostasis.
Day 1
Day 3
Day 7
Day 14
1 month
3 months
|
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/06/2026 |
| 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 is a prospective randomized controlled clinical trial designed to evaluate and compare the effectiveness of platelet rich fibrin alone, platelet rich fibrin combined with gelfoam, platelet rich fibrin combined with chitosan, and natural healing in mandibular third molar extraction socket healing. The study will be conducted in patients requiring surgical extraction of mandibular third molars attending the outpatient department of oral and maxillofacial surgery. Eligible participants aged 18 to 40 years with good general health will be recruited based on predefined inclusion and exclusion criteria and randomly allocated into four groups, PRF alone, PRF with gelfoam, PRF with chitosan, and control where no adjunct is used. The study will follow a standardized surgical extraction protocol and PRF preparation protocol, and it will be single blinded with assessor blinding, as patient and operator blinding are not feasible due to the visible nature of the materials and ethical considerations. Follow up assessments will be conducted at 30 minutes and 60 minutes post extraction, Day 1, Day 3, Day 7, Day 14, 1 month, and 3 months after surgery. The primary objective is to evaluate soft tissue healing and bone regeneration of extraction sockets among the four groups using clinical examination and radiographic assessment with intraoral periapical radiographs and grid analysis. Outcome parameters include soft tissue healing assessed using modified Landry healing index, bone regeneration assessed using radiographic measurements of alveolar bone height and anteroposterior socket width, hemostasis assessed by time to cessation of bleeding and modified bleeding severity scale, postoperative pain assessed using visual analogue scale, facial swelling assessed using standardized linear measurements between anatomical landmarks, trismus assessed by maximum inter incisal distance, and incidence of dry socket assessed clinically using standard diagnostic criteria. Data will be analyzed using appropriate statistical tests for intergroup and intragroup comparisons to determine whether addition of gelfoam or chitosan enhances the clinical and regenerative efficacy of platelet rich fibrin compared with PRF alone and natural healing, and to generate evidence based guidance for socket management following mandibular third molar extraction. |