| CTRI Number |
CTRI/2020/11/028974 [Registered on: 09/11/2020] Trial Registered Prospectively |
| Last Modified On: |
05/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of platelet rich fibrin matrix (PRFM) and demineralized freeze-dried bone allograft (DFDBA) in immediate implant. |
|
Scientific Title of Study
|
“Evaluation of effectiveness of platelet rich fibrin matrix with demineralized bone allograft in fresh extraction sockets with simultaneous Implant placement. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Bhombe |
| Designation |
Post Graduate |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Bank of India colony, Nagpur road, Nalwadi, WARDHA- MAHARASHTRA PIN - 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8805259554 |
| Fax |
|
| Email |
kbhombe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Baliga |
| Designation |
Professor |
| Affiliation |
BDS, MDS, MPhil, PhD |
| Address |
Department of Periodontics
Sharad Pawar Dental College Sawangi
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923604066 |
| Fax |
|
| Email |
baligavs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Bhombe |
| Designation |
Post Graduate |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Bank of India colony, Nagpur road, Nalwadi, WARDHA- MAHARASHTRA PIN - 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8805259554 |
| Fax |
|
| Email |
kbhombe@gmail.com |
|
|
Source of Monetary or Material Support
|
| DiponED Biointelligence, Bangaluru |
|
|
Primary Sponsor
|
| Name |
The Indian Council of Medical Research |
| Address |
The Indian Council of Medical Research
New Delhi, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Komal Bhombe |
Sharad Pawar Dental College |
Sawangi(Meghe)
Wardha
MAHARASHTRA |
8805259554
kbhombe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Teeth indicated for extraction |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immediate Implant |
Atraumatic extraction followed by Immediate Implant placement
single implant will be placed immediately following the extraction. The remaining gap distance will be filled with autologus PRFM and Particulate bone graft as per the size of the defect.
The patients will be followed 6 months after surgery. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Tooth which needs extraction due to root fractures, endodontic failures, internal and external resorption, over-retained deciduous teeth, non-restorable carious lesions, residual roots.
2. Good oral hygiene described as full mouth plaque score of ≤ 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. Presence of ≥4 mm of bone beyond root apex.
8. D-1, D-2 or D-3 bone quality.
|
|
| ExclusionCriteria |
| Details |
Systemic diseases that compromise bone healing process e.g. (diabetes, bleeding disorders, osteoporosis and allergies to titanium).
2. Severe maxilla-mandibular space discrepancies.
3. Para functional habits like bruxism and/or clenching.
4. Teeth with interdental spacing/ Proclinated teeth/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 |
| vertical and horizontal crestal bone changes around immediately placed implants. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| implant mobiliy. |
baseline, 3 months and 6 months |
|
|
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)
|
13/11/2020 |
| 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="13" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Dr. Komal Bhombe, Dr. Vidya Baliga. Evaluation of effectiveness of platelet rich fibrin matrix (PRFM) and demineralized freeze-dried bone allograft (DFDBA) placed into fresh extraction sockets with simultaneous Implant placement: A clinical and radiographic study. JCR. (2019), [cited September 15, 2020]; 6(6): 819-826. doi:10.31838/jcr.06.06.137 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND: Implant
dentistry has evolved over time with various novel protocols. These protocols
have guided in making the implant placement easier to a point that now the
outcomes can be predicted to a greater extent. Research using biomaterials such
as blood derived membranes and bone grafts have assisted in constant success of
this therapy. Several strategies including
placement of immediate implants have been proposed to preserve post extraction
alveolar ridge from resorption during healing. The immediate implant treatment
protocol serves many advantages including minimal surgical interventions, thus
reducing total treatment time, preservation of adequate bone height and aesthetic
outcomes especially in anterior region.
AIM: This study will be undertaken to evaluate effectiveness of implant
placement immediately followed by tooth removal with simultaneous PRFM and
DFDBA grafting using a two-stage protocol.
MATERIAL AND METHODS: This
study will be performed over one year period. Twelve patients, each having one
tooth indicated for extraction in the maxilla and/or mandible will be selected.
Implants will be placed into fresh extraction socket after augmentation with
autologous platelet concentrate and bone graft, using two stage protocol.
Second stage study will be performed 5-6 months following implant placement.
Abutments will be connected within 3-6 weeks and definitive metal ceramic
restoration will be placed.
EXPECTED RESULTS:
The success of the implant will be determined by the crestal bone changes and
stability after 6 months following the use of PRFM and Bone graft (DFDBA).
CONCLUSION: The
augmentation procedures have proved to be effective to achieve bone fill as
well as resolution of bone defects in surrounding implants. Bone augmentation
along with simultaneous implant placement may result in reduction of horizontal
bone resorption.
KEYWORDS:
Immediate implant, PRFM, DFDBA, Extraction socket, Atraumatic extraction.
|