CTRI Number |
CTRI/2021/12/038608 [Registered on: 14/12/2021] Trial Registered Prospectively |
Last Modified On: |
13/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Single Arm Study |
Public Title of Study
|
Effectiveness of T-PRF and DFDBA in socket preservation for implant placement. |
Scientific Title of Study
|
Evaluation of the effectiveness of titanium-prepared platelet rich fibrin (T-PRF) and demineralized freeze-dried bone allograft (DFDBA) in socket preservation followed by implant placement using two stage approach.†|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ranu Oza |
Designation |
Post graduate student |
Affiliation |
Post graduate student, Sharad Pawar Dental College |
Address |
Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001
Wardha MAHARASHTRA 442001 India |
Phone |
08669021556 |
Fax |
|
Email |
ranuoza@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Prasad Dhadse |
Designation |
Professor and Head |
Affiliation |
Professor and Head, Sharad Pawar Dental College |
Address |
Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001
Wardha MAHARASHTRA 442001 India |
Phone |
09822689401 |
Fax |
|
Email |
drprasaddhadse@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ranu Oza |
Designation |
Post graduate student |
Affiliation |
Post graduate student, Sharad Pawar Dental College |
Address |
Department of Periodontics, Sharad Pawar Dental College, Wardha, Sawangi, 442001
Wardha MAHARASHTRA 442001 India |
Phone |
08669021556 |
Fax |
|
Email |
ranuoza@gmail.com |
|
Source of Monetary or Material Support
|
Sharad Pawar Dental College and Hospital, Sawangi, Meghe, Wardha, 442001 |
|
Primary Sponsor
|
Name |
Sharad Pawar Dental College and Hospital |
Address |
Sharad Pawar Dental College and Hospital, Wardha: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 Ranu Oza |
Sharad Pawar Dental College and Hospital |
Department of Periodontics, Room number 03, Wardha, Sawangi, 442001 Wardha MAHARASHTRA |
07588415693
ranuoza@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 |
Root piece |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Atraumatic extraction followed by ridge preservation.
Implant placement after 3 months |
Ridge preservation using DFDBA+T-PRF
Intraoral placement of T-PRF and DFDBA into extraction socket.
After 3 months dental implant to be placed |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Inclusion criterias:
1. Tooth indicated for extraction. Reasons might be any one like, fracture of root, failure of endodontic treatment, resorption (internal and external), over-retained primary teeth, non-restorable carious lesions, residual roots.
2. Oral hygiene indicated with plaque score ≤ 25%.
3. Presence of opposing natural tooth.
4. Presence of adjacent teeth.
5. Thick gingival biotype.
6. Radiographic and clinical appearance of intact alveolar bony walls.
7. 4 mm of bone radiographically at root apex
8. D-1, D-2 or D-3 bone quality.
|
|
ExclusionCriteria |
Details |
Exclusion criterias:
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. Width of keratinized gingiva less than 2mm at implant site.
8. Debilitating tempro-mandibular joint pathosis.
9. Untreated dental diseases.
10. Pregnant and lactating mothers.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. To evaluate bucco-lingual changes of sockets before and after ridge preservation.
2. To evaluate vertical and horizontal crestal bone changes around post extraction implant placement.
3. To evaluate success rate of delayed implant placement in ridge preservation / socket preservation.
|
To be evaluated after 3 months of ridge preservation and then after 3 months of implant placement |
|
Secondary Outcome
|
Outcome |
TimePoints |
NIL |
NIL |
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
15/12/2021 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
ABSTRACT
Background: Implant dentistry has evolved over time with various
novel protocols. The focus of the implant therapy is now
shifting to a stable restoration rather than mere osseointegration. Placement of dental implants has become an
indispensable part of mainstream dentistry, offering an improved quality of
life to patients. The primary indicator for the repair or preservation of
osseous structures following disease or trauma is the rehabilitation of
edentulous ridges to allow the installation of endosseous implants. One of the
physiological changes that occurs after tooth extraction is alveolar ridge
resorption. The first year
after tooth extraction sees major dimensional shifts in the extraction socket,
with two-thirds of the bone loss occurring during the first three months. A variety of bone graft materials and platelet concentrates which
are abundant in growth factors have been incorporated that provides the added
effect of combination for early and better healing.
Objectives: Evaluation of effectiveness of “Titanium Prepared Platelet Rich
Fibrinâ€(T-PRF) and “Demineralized Freeze-Dried Bone Graftâ€(DFDBA) in socket
preservation and simultaneous evaluation of implant stability three months after implant placement using two
stage protocol.
Methodology: Present study will be performed over one year period. Twelve
patients, each having one tooth indicated for extraction in either of the
arches will be selected. Atraumatic extraction will be done followed by socket
preservation using combination of T-PRF and DFDBA to promote early healing
followed by placement of implant.
Expected results: We expect early and better results of bone formation in healing
sockets after preservation using T-PRF and DFDBA, which will be advantageous
for implant placement. Better results in terms of bone volume, bone height,
bone density and histomorphometry are expected.
Conclusion: Combination of T-PRF and DFDBA is expected of
creating novel outcomes.
Keywords: T-PRF, Socket Preservation, Dental Implant, DFDBA. |