| CTRI Number |
CTRI/2025/10/095998 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The role of antibiotic loaded blood component in enhancing bone healing and implant stability. A clinical study |
|
Scientific Title of Study
|
Evaluation and comparison of the effects of antibiotics loaded A-PRF placed in extraction sockets on bone formation, implant stability and insertion torque in early implant placement at 8 Weeks - A Randomized
Controlled 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 Putta Sri Lakshmi Prasanna Anjaneyulu |
| Designation |
Post graduate student. |
| Affiliation |
Vishnu Dental College. |
| Address |
pg clinic no 8,block no 2, department of Prosthodontics and Implantology,
Vishnu Dental College,Vishnupur,Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9505868117 |
| Fax |
|
| Email |
puttaanjaneyulu2111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Satyanarayana Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College. |
| Address |
pg clinic no 8,block no 2, department of Prosthodontics and Implantology,
Vishnu Dental College,Vishnupur,Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Satyanarayana Raju |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College. |
| Address |
pg clinic no 8,block no 2, department of Prosthodontics and Implantology,
Vishnu Dental College,Vishnupur,Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293809 |
| Fax |
|
| Email |
satya@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Putta Sri Lakshmi Prasanna Anjaneyulu |
| Address |
Vishnu Dental College,Vishnupur,Bhimavaram.
pg. clinic no 8,Prosthodontics and Implantology,Bhimavaram,Vishnupur. |
| 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 Putta Sri Lakshmi Prasanna Anjaneyulu |
Vishnu Dental College |
PG clinic no: 8, Block 2,First Floor, Department Of Prosthodontics Crown and Bridge, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
9505868117
puttaanjaneyulu2111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comitiee,Vishnu Dental College. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K083||Retained dental root, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A-PRF therapy |
A-prf is prepared with patients own blood, at the time of extraction procedure and it is placed in extraction socket. Post operative systemic antibiotic therapy is indicated with Amoxicillin/Clavulanic Acid 625mg twice daily for three days or Clindamycin 150mg twice daily for three days |
| Intervention |
Amoxicillin/Clavulanic acid loaded A-PRF therapy |
0.5ml of 1.2gm Amoxicillin/clavulanic acid is loaded into A-PRF plug prepared from patient own blood. The plug is placed into the alveolar socket and the drug is loaded immediately into the plug |
| Intervention |
clindamycin loaded A-PRF therapy |
0.5ml of 600mg/4ml of clindamycin is loaded into A-PRF plug prepared from patient own blood. The plug is placed into the alveolar socket and the drug is loaded immediately into the plug |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists (ASA) -1 category
2.Bilateral or unilateral with one or more teeth advised for extraction in the premaxillary region.
3Non-restorable carious lesion
4.Root resorption, root caries and root fracture with questionable prognosis
5.Intact buccal cortical plate after extraction
|
|
| ExclusionCriteria |
| Details |
1.Patients subjected to radiotherapy in the head and neck.
2.Patients with poor compliance and smokers
3.Medical conditions or medications known to alter soft tissue or bone healing
4.Systemic infections
5.Roots extending into maxillary sinus
6.Dehiscence in buccal cortical plates after extraction
7.Patient on systemic antibiotics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| histomorphometric analysis |
2 months after extraction,while placing dental implant. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| insertion torque. |
2 months at the time of implant placement. |
| implant stability |
0,1 and 3 months. |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
30/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized,parallel group, multiple arm study, comparing the safety and efficacy of amoxicillin/clavulanic acid and clindamycin as an agents in local drug delivery evaluating soft and hard tissue healing ,this study contains one control and two experimental groups, comparing 0.5 ml of amoxicillin/clavulanic acid(1.2)gm in experimental group one and 0.5 ml of clindamycin(600mg/4 ml) in experimental group two, loaded into the A-PRF as local drug delivery placed into the extraction sockets without any postoperative antibiotics compared with control group where A-PRF alone is placed in the extraction sockets with post operative antibiotics prescribed. Primary out come is bone healing assessment (histomorphometric analysis) by bone coring at the time of dental implant placement ,secondary outcomes are insertion torqe at the time of implant placement, implant stability at 0,1and 3 months compared in both experimental and control groups. |