| CTRI Number |
CTRI/2021/06/034263 [Registered on: 16/06/2021] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Preservation of socket dimension after tooth removal by using bone graft and blood derived platelet concentrates
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Scientific Title of Study
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Biologically Oriented Alveolar Ridge Preservation using Demineralized Freeze Dried Bone Allograft(DFDBA)With Albumin-Platelet Rich Fibrin Biofiller Compared To DFDBA And Blood Clot Alone In Extraction Socket Preservation-A Randomized Controlled Study |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smitha K |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Government Dental college and Research Institute,B |
| Address |
Room No 3 Department of Periodontology Government Dental College and Research Institute Fort Victoria hospital campus KR MARKET Bangalore
KR MARKET
Bangalore
KARNATAKA
560002
India |
| Phone |
09449630572 |
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smitha K |
| Designation |
Professor and Head Of The Department |
| Affiliation |
Government Dental college and Research Institute,B |
| Address |
Room No 3 Department of Periodontology Government Dental College and Research Institute Fort Victoria hospital campus KR MARKET Bangalore
KR MARKET
KARNATAKA
560002
India |
| Phone |
09449630572 |
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswathi S Nair |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Government Dental college and Research Institute,B |
| Address |
Room No 3 Department of Periodontology Government Dental College and Research Institute Fort Victoria hospital campus KR MARKET Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9496736946 |
| Fax |
|
| Email |
aswathinair369@gmail.com |
|
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Source of Monetary or Material Support
|
| Government dental college and a Research Institute |
|
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Primary Sponsor
|
| Name |
Government Dental college and Research InstituteBangalore |
| Address |
Fort ,K R market,
Victroria hospital campusBangalore |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smitha K |
Government Dental college and research institute,Bangalore |
RoomNo3,Department of periodontology,Fort,Victoria Hospital Campus,KR market,Bangalore
Bangalore
KARNATAKA |
09449630572
periosmitha@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Review board,Government Dental College and Research Institute,bangalore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Type 1 extraction socket with buccal plate measuring greater than or equal to 1 mm and less than or equal to 3 mm in thickness with adjacent teeth in periodontal health |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biologically oriented alveolar ridge preservation(BARP) using Demineralized Freeze Dried Bone Allograft(DFDBA) with albumin platelet rich fibrin biofiller(Alb-PRF) for extraction socket preservation. |
Alb-PRF will be prepared according to the following protocol:For PRF preparation 5 ml blood will be collected from subjects and transferred to vacutainer tubes without anticoagulant and is centrifuged at 2700 rpms for 12 mins at room temperature. The PRF clot will be present in the middle of the tube,just between a jelly like red blood cell layer at bottom and a supernatant serum at the top which is removed with sterile tweezer. The PRF clot and the upper layer (platelet-poor plasma layer) will be collected in 5 ml sterile glasstubes and heated at 75°C for 10 minutes using a water bath to create denatured albumin gel(Alb). Following heating, the albumin gel will be allowed to cool to room temperature for 10 minutes. Then the remaining cells containing growth factors found within the buffy coat layer will be thereafter coated with the cooled albumin gel to form Alb-PRFwhich will be placed into the apical part of the socket. This combination combines lower-resorption properties of the albumin gel with the higher cell content and growth factorcontent of the PRF.
The socket will be filled with Alb- PRF Biofiller up to 4-5 mm from the most coronal extension of the bone crest which acts as a scaffold. DFDBA graftis placed on top of the biofiller to fill the coronal part of the socket (graft layer). Socket sealing will be performed by placing gelatin sponge over the exposed portion of the graft, and the socket is then sutured using hidden x suturing technique with 4-0 silk suture.No effort will be made to approximate the wound margins by approximating the flaps. |
| Intervention |
DFDBA alone for extraction socket preservation. |
The same DFDBA as used above will be hydrated with sterile saline and added in the sockets with light compression up to the bony crest. Socket sealing will be then performed by placing gelatin sponge over the exposed portion of the graft, and the socket is then sutured using hidden x suturing technique with 4-0 silk suture. |
| Comparator Agent |
Naturally Healing Extraction socket with blood clot alone |
Further curettage of the socket walls will be performed to allow the socket to fill with blood up to the bony crest. The gelatin sponge will be applied in the same manner as described above and suturing is done using hidden X suturing technique with 4-0 silk suture. |
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Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects of age 19-45yrs.
ASA(American Society Of Anaesthetologists) Physical status 1.
Hopeless or non-restorable single tooth indicated for extraction and future implant placement.
Type 1 extraction socket with buccal plate measuring greater than or equal to 1 mm and less than or equal to 3 mm in thickness, with adjacent teeth in periodontal health.
|
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| ExclusionCriteria |
| Details |
Subjects with compromised medical conditions contraindicating the surgical procedures.
Subjects taking medication influencing the bone metabolism and bone healing.
Subjects with the habit of smoking.
Subjects with known metabolic disorders.
Subjects in which tooth is extracted due to periodontal breakdown.
Subjects with acute infection ( or presence of pus) in or close to the site intended for extraction.
Pregnant and Lactating mothers.
Subjects with poor oral hygiene.
Subjects who are allergic to any of the materials used in the study
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Bone dimensional changes (bone height, bone width and bone mineral density) between the three groups as assessed by CBCT is set as the primary outcome |
Bone dimensional changes (bone height, bone width and bone mineral density) from baseline to 4 months post-operatively between the three groups as assessed by CBCT is set as the primary outcome. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Soft tissue healing index [Landry R, Turnbull R and Howley T, 1988].
2.Buccolingual ridge width using bone calipers
|
1.soft tissue healing index will be measured at the 7th day, 14th day and 4 months postoperatively.
2.Buccolingual width measured using bone calipers will be measured at baseline(after extraction)and 4 months postoperatively.
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Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2021 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
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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
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [periosmitha@gmail.com].
- For how long will this data be available start date provided 05-06-2021 and end date provided 05-07-2024?
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
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Brief Summary
|
Alveolar bone resorption that occurs after tooth loss yields diminished alveolar ridge dimensions.Alveolar ridge preservation(ARP)) aids the surgeon in achieving optimal placement of implant with desired implant diameter while maintaining the aesthetics of overlying tissues.Studies have revealed that grafting of the alveolus results in persistence of residual graft particles embedded into the newly formed bone delaying the rate of bone deposition and mineralization.To overcome this a simplified,novel technique was introduced,namely, Biologically Oriented Alveolar Ridge Preservation(BARP) for ARP that restricts socket grafting to the coronal portion of the socket. Albumin-Platelet rich fibrin(Alb-PRF) is prepared by mixing Heat treated platelet poor plasma(albumin gel)and the buffy coat layer(liquid PRF).This combination allows lower resorption properties of albumin gel along with higher cellular and growth factor content of the liquid PRF layer to be remixed.DFDBA has been shown to have osteoinductive potential and produce more vital bone.To our knowledge,no study has been conducted comparing the clinical efficacy of Biologically oriented alveolar ridge preservation (BARP) using DFDBA with Albumin-Platelet rich fibrin(Alb-PRF) biofiller ,DFDBA alone and naturally healing extraction socket with blood clot alone in extraction socket preservation.Hence this study is designed with the aim to evaluate and compare the efficacy of BARP using DFDBA with Alb-PRF biofiller, DFDBA alone and naturally healing extraction socket with blood clot alone in preserving alveolar ridge dimensions after tooth extraction. |