| CTRI Number |
CTRI/2025/04/085686 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of immediate placing of implant after tooth removal vs delayed placement of implant after 2 months of tooth removal using blood derived concentrates.
|
|
Scientific Title of Study
|
Comparing the efficacy of immediate implant placement vs delayed implant
Placement following socket preservation : A randomised controlled clinical 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 |
Dr S JANITHA |
| Designation |
Associate Professor |
| Affiliation |
Government dental college and research institute |
| Address |
Room No 3 Department of Periodontology Government DentalCollege and Research Institute Fort Victoria hospital campus KRMARKET Bangalore KR MARKET
BangaloreKARNATAKA560002
India
Bangalore
KARNATAKA
560002
India |
| Phone |
9901119025 |
| Fax |
|
| Email |
janithasubramani@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 |
| Address |
Room No 3 Department of Periodontology Government DentalCollege and Research Institute Fort Victoria hospital campus KRMARKET Bangalore KR MARKET
BangaloreKARNATAKA560002
India
Bangalore
KARNATAKA
560002
India |
| Phone |
09449630572 |
| Fax |
|
| Email |
periosmitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHAMMED ABRAR ARSHAD |
| Designation |
postgraduate student |
| Affiliation |
Government Dental College and Research Institute |
| Address |
Room No 3 Department of Periodontology Government DentalCollege and Research Institute Fort Victoria hospital campus KRMARKET Bangalore KR MARKET
BangaloreKARNATAKA560002
India
Bangalore
KARNATAKA
560002
India |
| Phone |
7019458602 |
| Fax |
|
| Email |
drabrar114@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College And Research institute Bangalore, near kr market,bangalore fort,bengaluru 560002, India |
|
|
Primary Sponsor
|
| Name |
Government Dental college and Research InstituteBangalore |
| Address |
Room No 3 Department of Periodontology Government DentalCollege and Research Institute Fort Victoria hospital campus KRMARKET Bangalore KR MARKET
BangaloreKARNATAKA560002
India
|
| 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 MOHAMMED ABRAR ARSHAD |
Government Dental College and Research Institute, Bangalore |
Room No 3 Department of Periodontology Government DentalCollege and Research Institute Fort Victoria hospital campus KRMARKET Bangalore KR MARKET
BangaloreKARNATAKA560002
India
Bangalore
KARNATAKA |
7019458602
drabrar114@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee and Review Board , Government Dental College and Research Insititute, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
• Socket preservation with PRF and delayed implant placement.(DIP) |
An atraumatic extraction using periotome and forceps will be performed as mentioned. PRF obtained from subject’s own blood will be filled into the socket up to the bony crestwith
light compression. Furthur, socket sealing will be performed by placing gelatin sponge over the exposed portion of the PRF, and the socket is then sutured using hidden x suturing technique with 4-0 silk suture.At 2 months of socket preservation, sites will be re entered for implant placement. After the administration of local anaesthesia, full thickness mucoperiosteal flap will be elevated using crestal incision.The preparation of osteotomy and implant placement will be in the prosthetically desired position and according to implant kit manufacturer’s instructions and sutured.pt will be reaclled after 4 months for prosthesis
|
| Intervention |
• Socket preservation with PRF and immediate implant placement (IIP) after extraction |
Atraumatic extraction involved an intrasulcular incision using a 15c blade and the insertion of a periotome in a wedging action on all sides around the root except for the labial surface. Then, the root will be luxated and removed using a root forceps. •The socket will be thoroughly debrided and irrigated with sterile saline to remove residual tissue and promote appropriate bleeding. The implant osteotomy will be prepared so that the implant engaged at least 3–5 mm of the bone apical to the extraction socket to achieve sufficient primary stability. Implants will be placed 1–2 mm apical to the buccal alveolar crest. Regarding the buccolingual position, implants will be placed slightly palatal to have at least a 2 mm buccal gap between the implant and the inner surface of the buccal plate. Following implant placement, the buccal gap will be filled with PRF to the level of the gingival margin. Flaps will be stabilized using a cris-cross hidden- X suture.patient will be recalled after 4 months of implant placement for prosthesis. |
|
|
Inclusion Criteria
|
| Age From |
24.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male and female subjects of >24 yrs of age Single non restorable tooth.
Thick gingival biotype,Adequate bone volume for the placement of immediate implant- D2and D3,An intact socket wall following extraction – Class 1 (kim 2020)
|
|
| ExclusionCriteria |
| Details |
History of any systemic disease. Medications that might affect bone turnover as bisphosphonates,Smokers,Any signs of any acute infection at the surgical site or the adjacent natural teeth,External or internal resorptions,Severe periodontal destruction at the site of implant placement,Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) Marginal bone loss and Horizontal width is measured between the groups as assessed by CBCT is set as the primary outcome |
at baseline , 4 months post implant placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Soft tissue healing index [Landry R, Turnbull Rand Howley T, 1988].
To asses pink esthetic score (PES)
|
1. soft tissue healing index will be measured atthe 7th day, 14th day & 4 months postoperatively.
2. To asses pink esthetic score (PES) as
T0- at baseline
T1- 4 months after implant placement.
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
10/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
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. To overcome this Immediate installation at the time of
extraction offers potential advantages for both practitioners and subjects. It
allows a decrease in treatment time and may result in an increase in subject
satisfaction.Some clinicians have argued that immediate implant installation
may prevent alveolar bone resorption and thus decrease the need for bone
augmentation procedure. Other‘s have questioned such benefits and highlighted
that immediate implant placement at the time of tooth extraction is associated
with an increase in surgical complications and may result in suboptimal
aesthetic outcomes . The
applications of platelet concentrate seem to enhance stability of implants and
have been used for socket preservation and along with immediate implant
placement.Hence this study is designed with the aim to is
to
compare efficacy of Immediate Implant Placement versus Delayed Implant
Placement following Socket Preservation using PRF. |