| CTRI Number |
CTRI/2024/12/078652 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Bone Grafting Techniques for Dental Implants: Using Standard Bone Graft vs. Bone Graft with Healing Factors for Faster Recovery.
|
|
Scientific Title of Study
|
Comparative evaluation of Demineralized Freezed Dried Bone Allograft Vs Demineralized Freezed
Dried Bone Allograft with Platelet Rich Fibrin in Immediate implant replacement |
| 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 Melwin Ebenezer J |
| Designation |
Postgraduate student |
| Affiliation |
|
| Address |
Room no 3, Department of Oral and Maxillofacial surgery,
Sree Balaji Dental College & Hospital
Velachery Main Road,
Pallikaranai,
Chennai - 600 100.
Tamilnadu, India
Chennai
TAMIL NADU
600100
India |
| Phone |
8870090042 |
| Fax |
|
| Email |
melwinomfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balakrishnan R |
| Designation |
Professsor |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no 3, Department of Oral and Maxillofacial surgery,
Sree Balaji Dental College & Hospital
Velachery Main Road,
Pallikaranai,
Chennai - 600 100.
Tamilnadu, India
Chennai
TAMIL NADU
600100
India |
| Phone |
8870090042 |
| Fax |
|
| Email |
drbalakrishnanomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Melwin Ebenezer J |
| Designation |
Postgraduate student |
| Affiliation |
Sree Balaji Dental College and Hospital |
| Address |
Room no 3, Department of Oral and Maxillofacial surgery,
Sree Balaji Dental College & Hospital
Velachery Main Road,
Pallikaranai,
Chennai - 600 100.
Tamilnadu, India
Chennai
TAMIL NADU
600100
India |
| Phone |
8870090042 |
| Fax |
|
| Email |
melwinomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mil Medical Dental Systems Private Limited, Rasoya House, Kheta Layout, NH7, 2nd floor, Plot no 20/21, Wardha Rd, New Sneh Nagar, Nagpur, Maharashtra , India 440015 |
|
|
Primary Sponsor
|
| Name |
Dr Melwin Ebenezer J |
| Address |
Room no 3, Department of Oral and Maxillofacial surgery,Sree Balaji Dental College & Hospital
Velachery Main Road,
Pallikaranai,
Chennai - 600 100.
Tamilnadu, India |
| Type of Sponsor |
Other [self] |
|
|
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 Melwin Ebenezer J |
Sree Balaji Dental College And Hospital |
Room No 3
Department of oral and Maxillofacial Surgery ,Sree Balaji Dental College & Hospital
Velachery Main Road,
Pallikaranai,
Chennai - 600 100.
Tamilnadu, India
Chennai
TAMIL NADU |
8870090042
melwinomfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE BALAJI DENTAL COLLEGE AND HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Demineralized freeze dried bone allograft |
DFDBA stands for Demineralized Freeze-Dried Bone Allograft. It’s a bone graft material commonly used in dental procedures to promote bone regeneration. DFDBA is derived from human bone, which undergoes a process to remove mineral content while preserving bone-inducing proteins, such as BMPs (bone morphogenetic proteins). This makes it particularly effective for stimulating new bone formation when placed in areas needing regeneration, like in implant sites or defect areas in the jaw.
Because DFDBA is an allograft (from a donor), it integrates well with the patient’s own bone, encouraging osteoconduction (providing a scaffold for new bone growth) and, in some cases, osteoinduction (actively stimulating bone growth). |
| Intervention |
Platelet rich fibrin |
PRF is obtained from the patients own blood through a process of centrifugation without any additives. This allows for a natural concentration of platelets and growth factors, which are essential for healinng.PRF contains growth factors like PDGF (platelet-derived growth factor), TGF-β (transforming growth factor-beta), and VEGF (vascular endothelial growth factor), which play a crucial role in tissue regeneration and angiogenesis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Requires extraction of Non-restorable Maxillary Anterior Teeth (Vertical tooth fracture,Grossly decayed,RC failure)
Patients who are willing to participate in studt
|
|
| ExclusionCriteria |
| Details |
patients with more than 50percent bone loss
uncontrolled systemic disease
severe parafunctional habits
poor oral hygiene maintenance
pregnancy
patients under medications that compromises bone healing |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Good Osseointegration |
3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in pain
Reduction in swelling
Increased soft tissue healing |
3 month,6 month |
|
|
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 3 |
|
Date of First Enrollment (India)
|
07/01/2025 |
| 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 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
|
A randomized controlled clinical trial will be carried out on said sample sizes of non-restorable single rooted teeth sites(Maxillary anteriors). Sites were randomized into demineralized freeze dried bone allograft (DFDBA) combined with PRF as test group and only DFDBA as control groups using a coin toss method.Sequential drilling will be followed and Implant will be placed in the prepared osteotomy site .After the placement of graft material, PRF membrane was used to cover it. The clinical parameters recorded were bone healing ,formation & implant stability . All the parameters were recorded at baseline and at 90 and 180 days |