| CTRI Number |
CTRI/2024/05/068192 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Effectiveness of DFDBA Bone graft with Titanium Platelet Rich Fibrin (T-PRF) and Autologous Dentin Graft (ADG) with T-PRF in socket preservation after extraction |
|
Scientific Title of Study
|
Comparative
Evaluation of
Effectiveness of Demineralized
Freeze-Dried
Bone
Allografts
(DFDBA) with Titanium Platelet
Rich Fibrin
(T-PRF)
and Autologous Dentin Graft (ADG) with T-PRF in Alveolar Socket Preservation: A Randomised Control 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 |
Shivani Prafulla Thakre |
| Designation |
post graduate student,Department Of Periodontics and Implantology |
| Affiliation |
Sharad Pawar Dental College, Sawangi (Meghe) |
| Address |
Room NO. 003, Ground Floor, Department Of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007149767 |
| Fax |
|
| Email |
thakareshivani21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pavan Bajaj |
| Designation |
Associate professor, Department Of Periodontics and Implantology |
| Affiliation |
Sharad Pawar Dental College, Sawangi (Meghe) |
| Address |
Room NO. 003, Ground Floor, Department Of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8412045019 |
| Fax |
|
| Email |
pavbajaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivani Prafulla Thakre |
| Designation |
post graduate student,Department Of Periodontics and Implantology |
| Affiliation |
Sharad Pawar Dental College, Sawangi (Meghe) |
| Address |
Room NO. 003, Ground Floor, Department Of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA
442001
India |
| Phone |
8007149767 |
| Fax |
|
| Email |
thakareshivani21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept no 003, Department of periodontics and Implantology,Sharad Pawar Dental College,Datta Meghe Institute Of Higher Education and Research Campus, Sawangi (Meghe), Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College Sawangi Meghe Wardha |
| Address |
Datta Meghe Institute Of Higher Education and Research,Sawangi(Meghe), Wardha, Maharashtra, India, 442001
|
| 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 |
| Dr Shivani Prafulla Thakre |
Sharad Pawar Dental College Sawangi(Meghe) |
Room NO. 003, Ground Floor, Department Of Periodontics, Sharad Pawar Dental College, Datta Meghe Institute Of Higher Education and Research, Sawangi (Meghe),Maharashtra, India, 442001
Wardha
MAHARASHTRA |
8007149767
thakareshivani21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institiutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group - of Demineralized Freeze-Dried Bone Allografts (DFDBA) with Titanium Platelet Rich Fibrin (T-PRF) |
comparator : DFDBA+ T-PRF in control group |
| Intervention |
Test group- Autogenous dentin graft with T-PRF |
Intervention : ADG + T-PRF in test group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients indicated for implant following extraction. Because of reasons like, fracture of root, failure of endodontic treatment, resorption (internal and external), over-retained primary teeth, non-restorable carious lesions, residual roots.
2) A complete mouth plaque score of less than 25% indicates good oral hygiene.
3) Existence of a natural tooth in opposition
4) Adjacent teeth presence
5) Thick gingival biotype
6) The clinical and radiological appearance of the unbroken alveolar bone walls
7) 4 mm of bone radiographically at root apex
8) D-1, D-2 or D-3 bone quality.
|
|
| ExclusionCriteria |
| Details |
1. Patients with impaired systemic health that would interfere with the process involved with repair and healing of bones e.g. (Diabetes mellitus, Osteoporosis, Blood disorders, and Titanium allergy).
2. Significant differences in maxilla-mandibular space.
3. Presence of para functional habits such as bruxism or clenching.
4. Presence of proclined teeth, teeth with interdental spacing, rotated or mal-aligned anterior teeth.
5. History of alcoholism, excessive smoking or drug abuse.
6. D-4 bone quality.
7. Radiotherapy and chemotherapy history.
8. Debilitating tempro-mandibular joint pathosis.
9. Untreated dental diseases.
10. Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| radiographic analysis, we will access new bone formation, change in sockets vertical alveolar bone |
four months post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The main results are linear phenotypic dimensional changes, at baseline & four months after healing at two locations in the midfacial & midpalatal bone & soft tissue thickness. |
After four months of surgery |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="2"
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
|
AIM - assess and compare the effectiveness of DFDBA with T-PRF and ADG with T-PRF in socket preservation using clinical, radiological and histomorphometric analysis.
OBJECTIVES- Comparison of the effectiveness of DFDBA with T-PRF and ADG and T-PRF in alveolar ridge preservation therapy in terms of the quantity of newly formed bone and residual graft material that is histologically retained after four months of healing. METHODOLOGY- Sixteen patients having teeth indicated for extraction in maxilla and /or mandiblewill be selected. Eight patients in test group and eight patients in control group will be alloted. In test group ADG and T-PRF will be used and in control group DFDBA + T-PRF will be used. EXPECTED OUTCOME T-PRF along with Autologous dentin graft will lead to better radiographic bone fill and improved intrasocket measurements after 4 months of surgery. CONCLUSION- The socket preservation procedure have been proven to be effective in maintaining the ridge dimensions after extractions. socket preservation using ADG+ T-PRF may result in maintaing the alveolar ridge dimensions.
M
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