| CTRI Number |
CTRI/2024/09/074175 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between early and delayed implant placement in patients with tooth socket preservation done using the blood components |
|
Scientific Title of Study
|
Comparison of quality of bone formation, insertion torque and implant stability between early implant placement and delayed implant placement in sockets preserved with A-PRF A Randomized 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 |
Dr Neelarchana Seelam |
| Designation |
Post graduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge,PG - 8, Block - 2, Vishnu Dental College,Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
09515642045 |
| Fax |
|
| Email |
archanamaha04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A V Rama Raju |
| Designation |
Professor and Principal |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge, PG - 8, Block - 2, Vishnu dental college,Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9949372409 |
| Fax |
|
| Email |
ramarajuav@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A V Rama Raju |
| Designation |
Professor and Principal |
| Affiliation |
Vishnu Dental College |
| Address |
Department of Prosthodontics and Crown and Bridge, PG - 8, Block - 2, Vishnu dental college,Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9949372409 |
| Fax |
|
| Email |
ramarajuav@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,Vishnupur,Bhimavaram, West Godavari district, AndhraPradesh, India
Pincode 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Neelarchana Seelam |
| Address |
Post Graduate Student,Department of Prosthodontics, PG - 8, Block - 2, Vishnu Dental College,Vishnupur, Bhimavaram,pincode-534202 |
| Type of Sponsor |
Other [Self] |
|
|
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 Neelarchana Seelam |
Vishnu Dental College |
Department of Prosthdontics and Crown and Bridge, PG - 8, Block - 2, Vishnupur, Bhimavram,Pincode 534202
West Godavari
ANDHRA PRADESH |
9515642045
archanamaha04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 months evaluation of Alveolar Socket preservation done with Advanced-Platelet Rich Fibrin (A-PRF) |
Following the Atraumatic tooth extraction using a piezo surgical unit and luxators, the alveolar extraction socket will be packed with A-PRF plugs (prepared from the patients whole blood), covered with an A-PRF membrane, and allowed to heal. Clinical and histological evaluation of bone quality will be done after 2 months
|
| Comparator Agent |
3 months evaluation of Alveolar Socket preservation done with Advanced-Platelet Rich Fibrin (A-PRF) |
Following the Atraumatic tooth extraction using a piezo surgical unit and luxators, the alveolar extraction socket will be packed with A-PRF plugs (prepared from the patients whole blood), covered with an A-PRF membrane, and allowed to heal. Clinical and histological evaluation of bone quality will be done after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with age 20 – 50 years
2. American Society of Anaesthesiologists (ASA) -1 category
3. Bilateral or unilateral with one or more teeth advised for extraction in the maxillary premolar region
4. Non-restorable carious lesion
5. Root resorption, root caries and root fracture with questionable prognosis
6. Intact buccal cortical plate after extraction
|
|
| ExclusionCriteria |
| Details |
1. Patients subjected to radiotherapy in the head and neck
2. ASA – II, III, IV, V patients
3. Patients with poor compliance
4. Chronic smokers
5. Medical conditions or medications known to alter soft tissue or bone healing
6. Active local or systemic infection
7. Roots extending into the maxillary sinus
8. Dehiscence in buccal cortical plates after extraction |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Implant stability quotients (ISQ) between early implant placement and delayed implant placement |
At Baseline, 1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Insertion torque |
Baseline - at the time of implant placement. |
| Quality of bone formation |
Baseline - at the time of implant placement. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/09/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The success of dental implants largely depends on the quality of bone formation, the mechanical stability of the implant at the time of placement, and the long-term stability during the healing process. Bone quality and implant stability are critical determinants of osseointegration. Advanced platelet–rich fibrin (A-PRF) has emerged as a promising biomaterial for enhancing bone healing and regeneration. It contains a high concentration of growth factors and cytokines, which can accelerate tissue healing and bone regeneration. Preservation of extraction sockets using A-PRF aims to maintain the alveolar ridge’s volume and quality. This could solve ongoing debates in implant dentistry on optimal timing for implant placement following tooth extraction.This randomized control trial aimed to compare the quality of bone formation, insertion torque, and implant stability between early implant placement (EIP) at 8 weeks and delayed implant placement (DIP) at 12 weeks in extraction sockets preserved with advanced platelet-rich fibrin (A-PRF).Twenty patients requiring extractions in the maxillary premolar region will be randomized into two groups: EIP (Early Implant Placement - 8 weeks post-extraction) and DIP (Delayed Implant Placement - 12 weeks post- extraction). All the teeth will be extracted atraumatically using piezotomes, and sockets will be preserved using A-PRF. Primary outcomes of the study included histomorphometric analysis of bone, insertion torque values measured at the implant placement, and implant stability quotient (ISQ) measured at placement and after 1 and 3 months. |