| CTRI Number |
CTRI/2025/02/080695 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A research to study the bone formation capacity of dentin taken from an extracted natural tooth and mixed with a blood cell concentrate. |
|
Scientific Title of Study
|
Use of autologous partially demineralized dentinal matrix (PDDM) with novel injectable platelet-rich fibrin (i-PRF) for bone grafting after impacted mandibular third molar surgery– A randomized 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 S K Jagdish |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Prosthodontics, E-Block, Room No.7, 3rd Floor,
Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9940163850 |
| Fax |
|
| Email |
jagdishsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Jagdish |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Prosthodontics, E-Block, Room No.7, 3rd Floor,
Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9940163850 |
| Fax |
|
| Email |
jagdishsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S K Jagdish |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Prosthodontics, E-Block, Room No.7, 3rd Floor,
Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9940163850 |
| Fax |
|
| Email |
jagdishsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute,
Department of Prosthodontics and
Department of Oral Surgery,
Rajiv Gandhi Salai,
Kelambakkam, Kancheepuram District,
Pin - 603103. |
|
|
Primary Sponsor
|
| Name |
Dr S K Jagdish |
| Address |
Department of Prosthodontics, Chettinad Dental College and Research Institute, E-Block, 3rd Floor, Room No. 7, Rajiv Gandhi Salai, Kelambakkam, Pin - 603103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Jagdish |
Chettinad Dental College and Research Institute |
Department of Prosthodontics and Implantology, Chettinad Dental College and Research Institute, E-Block, 3rd Floor, Room No.7, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU |
9940163850
jagdishsk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad Dental College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Extraction of mandibular 3rd molar tooth followed by grafting with PDDM mixed with novel i-PRF graft material. |
Oral prophylaxis will be done and patients will be prescribed 0.2% chlorhexidine mouthwash before tooth removal. Surgical removal of the tooth will be done by an experienced Oral and Maxillofacial Surgeon under local anesthesia (2% Lignocaine with adrenaline). A baseline intra-oral periapical radiograph (IOPA) will be taken immediately after tooth extraction using a standardized technique and exposure.
To prepare the PDDM, all the soft tissues on the extracted tooth will be cleaned using a scaler. Caries/restorations will be removed using a high seed airotor with water. After airdrying the tooth will be ground into small particles using a grinder or bone mill. The particles will be demineralized using 0.6 N HCl for 30 minutes and washed with buffered saline (pH 7.0) three to four times.
To prepare the novel i-PRF, 10 ml of venous blood will be collected from the cubital vein of the patient in a silica-coated vacutainer tube and centrifuged at 2000 g for 3 minutes. The i-PRF layer along with the buffy coat will be aspirated and mixed the prepared PDDM graft and allowed to clot
The sockets in the test group will grafted with PDDM+ novel i-PRF graft followed by primary closure.
All patients will be scheduled for follow-up visits on the 3rd day, 14th day, and 3 months. Postoperative radiographs will be obtained at 3 months. |
| Comparator Agent |
Extraction of mandibular 3rd molar tooth followed by no grafting. |
Oral prophylaxis will be done and patients will be prescribed 0.2% chlorhexidine mouthwash before tooth removal. Surgical removal of the tooth will be done by an experienced Oral and Maxillofacial Surgeon under local anesthesia (2% Lignocaine with adrenaline). A baseline intra-oral periapical radiograph (IOPA) will be taken immediately after tooth extraction using a standardized technique and exposure. The sockets in the comparator group will not receive any graft material. The site will be cleaned and irrigated followed by primary closure. All patients will be scheduled for follow-up visits on the 3rd day, 14th day, and 3 months. Postoperative radiographs will be obtained at 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with impacted mandibular 3rd molar indicated for extraction.
2. Impacted - vertical, horizontal, or mesioangular with mild to moderate difficulty (Pederson Classification).
3. Teeth with minimal caries / minimally restored
4. Patients with adequate mouth opening preoperatively.
5. Patients willing to come for follow-up visits.
|
|
| ExclusionCriteria |
| Details |
1. Impacted teeth that are grossly decayed / severe loss of tooth structure.
2. Complicated extraction – curved roots, fracture of the bone, or excessive intraoperative hemorrhage.
3. Patients with smoking/tobacco use.
4. Uncontrolled systemic diseases/bone/ bleeding disorders.
5. Patients with abscesses or periapical lesions.
6. History of allergy to any drugs/biomaterials.
7. Patients with a history of radiotherapy/chemotherapy.
8. Using drugs that may affect bone metabolism and healing (eg. Bisphosphonates, steroids etc.,)
9. Pregnant and lactating women / contraceptive use.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the relative bone density in the surgical site |
At baseline (immediately after tooth removal) and at 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of post-operative pain, swelling, mouth opening |
Baseline (before extraction), 3rd day and 14th day |
| Graft loss/rejection and infection |
Baseline to 3 months |
| Radiographic bone healing using |
At baseline (immediately after tooth removal) and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jagdishsk@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Aims and Objectives: This study aims to assess the bone regeneration potential of PDDM + novel i-PRF when used in 3rd molar extraction sites. . Material and Methods: Ethical approval will be obtained before the study is stated. All the procedures will be done in adherence with the Declaration of Helsinki. Informed and written consent will be obtained from all the patients who are willing to participate. The CONSORT guidelines will be followed for reporting the study. The study will be conducted as a randomized trial with two parallel arms. All the patients will be randomly assigned to either the test (PDDM +i-PRF) group or the control (no graft) group. Before the surgery, oral prophylaxis will be done and patients will be prescribed 0.2% chlorhexidine mouthwash. Surgical removal of the tooth will be done by an experienced Oral and Maxillofacial Surgeon under local anesthesia (2% Lignocaine with adrenaline). A baseline intra-oral periapical radiograph (IOPA) will be taken immediately after tooth extraction using a standardized technique and exposure. To prepare the PDDM, all the soft tissues on the extracted tooth will be cleaned using a scaler. Caries/restorations will be removed using a high seed airotor with water. After airdrying the tooth will be ground into small particles using a grinder or bone mill. The particles will be demineralized using 0.6 N Hcl for 30 minutes and washed with buffered saline (pH 7.0) three to four times. To prepare the novel i-PRF, 10 ml of venous blood will be collected from the cubital vein of the patient in a silica-coated vacutainer tube and centrifuged at 2000 g for 3 minutes. The i-PRF layer along with the buffy coat will be aspirated and mixed the prepared PDDM graft and allowed to clot. The sockets in the test group will not receive any graft material. The site will be cleaned and irrigated followed by primary closure. The sockets in the test group will grafted with PDDM+ novel i-PRF graft followed by primary closure. Relative Bone Density measurement: On 3-month recall visit, a postoperative IOPA will be made using the same exposure parameters as done at baseline. The pre and post-IOPA images will be analysed in an image analysis software (Image J) to measure the change in the grayscale as described in previous reports. The change in the relative bone density (grayscale value) from baseline and 3 months will be calculated. All patients will be recalled for follow-up on the 3rd day and the 14th day. The suture removal will be done on the 14th day. Assessment of Pain: (3rd and 14th day) A 10-point Visual Analog scale (VAS) will be used for measuring the pain scores on the 3rd day and 14th day. A score of 0 indicates “No pain” and 10 indicates “severe pain”.
Facial swelling: (3rd and 14th day) The extent of facial swelling will be assessed using the method proposed by Schultze-Mosgau et al.[8] Briefly, the distance between the tragus to the corner of the lip and the tragus to the pogonion will be measured. The average of these measurements will be made pre-operatively and during the follow-up, visits. The change in the measurements from the baseline and on 3rd day, and 14th day will be expressed as percentages. Mouth Opening: (3rd and 14th day) The mouth opening will be measured as the maximum distance between the upper and lower incisors using a digital caliper. Trismus will be calculated as the difference in mouth opening at baseline and during follow-up visits and expressed as percentages.[8] Graft loss/ rejection and postoperative infection: All the patients will be followed for a period of 3 months. Any loss of the graft/ rejection or infection at the surgical site during the follow-up period will be noted.
Radiographic bone density and healing : The radiographic bone density will be measured using any image analysis software as greyscale values. The pre and post-IOPA images will be analyzed for bone healing using the scale proposed by Kelly et al.
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