| CTRI Number |
CTRI/2025/07/091854 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of bone graft and fibrin treatment compared to standard healing in adults after tooth extraction |
|
Scientific Title of Study
|
Efectiveness of xenograf and injectable PRF (I-PRF) Compared to Xenograft, and unassisted healing for Socket Preservatlon in Adults U ndergoing Tooth Extraction |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRAMEETHA GEORGE ITTYCHERIA |
| Designation |
Reader |
| Affiliation |
Pushpagiri college of dental sciences |
| Address |
Pushpagiri College of Dental Sciences
Department of Periodontology
Pushpagiri college of Dental sciences Thiruvalla Kerala Neelampilalil
Nellimala P.O
Eraviperoor Pathanamthitta KERALA 689107 India |
| Phone |
9495080021 |
| Fax |
|
| Email |
prameethageorgeittycheria@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PRAMEETHA GEORGE ITTYCHERIA |
| Designation |
Reader |
| Affiliation |
Pushpagiri college of dental sciences |
| Address |
Prameetha George Ittycheria
Reader
Department of Periodontology
Pushpagiri college of Dental sciences Thiruvalla Kerala
India
689107 Neelampilalil
Nellimala P.O
Eraviperoor
689542 Pathanamthitta KERALA 689107 India |
| Phone |
9495080021 |
| Fax |
|
| Email |
prameethageorgeittycheria@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
PRAMEETHA GEORGE ITTYCHERIA |
| Designation |
Reader |
| Affiliation |
Pushpagiri college of dental sciences |
| Address |
Prameetha George Ittycheria
Reader
Department of Periodontology
Pushpagiri college of Dental sciences Thiruvalla Kerala Neelampilalil
Nellimala P.O
Eraviperoor Pathanamthitta KERALA 689107 India |
| Phone |
9495080021 |
| Fax |
|
| Email |
prameethageorgeittycheria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pushpagiri college of Dental Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Prameetha George Ittycheria |
| Address |
Pushpagiri college of Dental Sciences,Medicity
Perumthururthy,Thiruvalla,Kerala,India 689107
|
| Type of Sponsor |
Other [] |
|
|
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 |
| PRAMEETHA GEORGE ITTYCHERIA |
Pushpagiri college of Dental sciences |
Room No 5
Department of Periodontology
Pathanamthitta KERALA |
09495080021
prameethageorgeittycheria@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pushpagiri Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
complete loss of teeth
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I-PRF ,Xenograft and membrane |
Socket preservation technique using injectable platelet rich fibrin,xenograft and membrane
Duration 6 month |
| Comparator Agent |
Group 2 Xenograft and membrane
Group 3 Unassisted healing. |
Socket preservation technique using xenograft and membrane in second group and third group unassisted healing.
Duration 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Maxillary and mandibular single rooted teeth requiring extraction .
2. Type 1,Type 2 extraction socket (Endodontic origin, fracture, severe caries, Periodontal origin, periodontal-endodontic combined )
3. more than or equal to 18 years of age
4. Patients with no systemic diseases
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled diabetes
2. Smokers (more than or equal to10 cigarettes/day)
3. Use of immunosuppressing medication
4. Use of anticoagulants
5. Pregnant women
6. Patients with Stage III or IV periodontal disease Grade C
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinically horizontal ridge width(buccolingual and mesiodistal) and vertical (mid-buccal, mid-lingual, mesial, and distal) ridge height.2 Using CBCT , (1) the mean width difference between the outer borders of the buccal and lingual cortical plates at 1, 3, and 5 mm socket depths, (2) the mean width of the buccal plate at the same depths.3.Histomorphometric analysis of the percentage of vital bone |
Clinical and radiographic meaurements at baseline and at 6 months
Histomorphometric analysis at 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Healing Index
socket length
bone density
|
3rd 7th 14th 21 days
baseline & after 6 months
baseline & after 6 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
20/08/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
The study will be published in indexed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Tooth extraction often leads to alveolar bone resorption, negatively affecting future prosthetic or implant rehabilitation. Socket preservation techniques have been introduced to minimize post-extraction bone loss, with biomaterials such as xenografts commonly used to maintain bone volume. Though graft materials can reduce alveolar bone resorption, grafted sites often have poor vascularization and nonvital residual particles which can negatively affect the bone to implant contact. A combination of autologous platelet concentrates with the graft which will improve the percentage of new bone formation Recently, injectable platelet rich fibrin has gained attention for its potential to enhance wound healing and bone regeneration due to its sustained release of growth factors. However, research on the combined use of injectable platelet-rich fibrin and xenografts for socket preservation remains limited. This study evaluates the clinical, radiographic, and histological outcomes of socket preservation using injectable platelet-rich fibrin , xenograft, and a resorbable membrane, compared to xenograft with a resorbable membrane and unassisted healing. Clinical parameters, including the gingival index and wound healing index, will be evaluated. Vertical and horizontal ridge width measurements will also be assessed using a digital caliper. Additionally, radiographic measurements using CBCT imaging will be performed to evaluate horizontal and vertical ridge dimensions, buccal plate thickness, and bone density. Histologic analysis after six months will assess new vital bone formation, connective tissue, and residual bone graft. Sample size calculated using the mean and SD of the loss of ridge height in the three groups from previous study ,is 15 per group . Patients will be randomly assigned to one of three groups using a permuted block randomization fixed method and allocation concealment by sequentially numbered sealed opaque envelops. Group 1 will receive socket preservation with xenograft, membrane, and injectable platelet-rich fibrin. Group 2 will receive xenograft and membrane and the control group will undergo unassisted healing. Clinical and radiographic parameters will be recorded after 6 months and the outcome assessor will be blinded. This comprehensive evaluation aims to determine the effectiveness of socket preservation using injectable platelet-rich fibrin and xenograft in maintaining ridge dimensions and increase in amount of vital bone and reduction in residual graft material there by promoting bone regeneration for future implant placement. |