| CTRI Number |
CTRI/2025/11/098076 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
25/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry
Other (Specify) [Biomaterial regeneration] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparative evaluation of Albumin Platelet-Rich Fibrin and Advanced Platelet-Rich Fibrin in periodontal regeneration: A clinical and radiological study |
|
Scientific Title of Study
|
Comparative Evaluation of Albumin Platelet-Rich Fibrin and Advanced Platelet-Rich Fibrin in Periodontal Regeneration: A Clinical and Radiological Study |
| Trial Acronym |
Alb-PRF vs A-PRF : RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amanda Antoinette Rebello |
| Designation |
(PG student) Dr. |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT (Deemed to be University) |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
516/1168/118 Arav Homes, Sampark Vihar Lane 1, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9004319565 |
| Fax |
|
| Email |
amandarebello.97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amanda Antoinette Rebello |
| Designation |
(PG student)Dr. |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT (Deemed to be University) |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
516/1168/118 Arav Homes, Sampark Vihar Lane 1, Patia, Bhubaneswar
ORISSA
751024
India |
| Phone |
9004319565 |
| Fax |
|
| Email |
amandarebello.97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amanda Antoinette Rebello |
| Designation |
(PG student) Dr. |
| Affiliation |
Kalinga Institute of Dental Sciences, KIIT (Deemed to be University) |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
516/1168/118 Arav Homes, Sampark Vihar Lane 1, Patia, Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9004319565 |
| Fax |
|
| Email |
amandarebello.97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr NAINA PATTNAIK |
| Address |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar
516/1168/118 Arav Homes, Sampark Vihar Lane 1, Patia, Bhubaneswar -751024 |
| Type of Sponsor |
Private medical college |
|
|
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 Amanda Antoinette Rebello |
Outpatient Department, Department No. 4 Department of Periodontology and Oral Implantology |
Department of Periodontology and Oral Implantology, Kalinga Institute of Dental Sciences, KIIT (Deemed to be university), KIIT Campus, Patia, Bhubaneswar - 751024
Khordha
ORISSA |
9004319565
amandarebello.97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE KALINGA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Advanced Platelet-Rich Fibrin (A-PRF) |
10 patients treated with Advanced Platelet-Rich Fibrin (A-PRF) in periodontal intrabony defects using the standard protocol.
|
| Intervention |
Albumin Platelet-Rich Fibrin (Alb-PRF) |
10 patients treated with Albumin Platelet-Rich Fibrin (Alb-PRF) in periodontal intrabony defects using the standard protocol.
|
| Comparator Agent |
Leucocyte Platelet-Rich Fibrin (L-PRF) |
10 patients treated with Leukocyte Platelet-Rich Fibrin (L-PRF) in periodontal intrabony defects using the standard protocol.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stage III Periodontitis Diagnosis:
Patients with moderate to severe periodontitis with at least one tooth exhibiting a two-wall, three-wall, or combined two- and three-wall intrabony defect measuring greater than or equal to 3 mm in depth.
Clinical Attachment Loss and Pocket Depth: Presence of CAL measuring greater than or equal to 5 mm and PPD measuring greater than or equal to 6 mm.
Exclusion of Furcation Defects
Vital Teeth
Medication and Antibiotic History
No Recent Periodontal Therapy
Informed Consent
Age Range: Only individuals aged 18–60 years.
Patient Compliance
Systemic Health Status: Participants must be systemically healthy
|
|
| ExclusionCriteria |
| Details |
Patients undergoing orthodontic treatment
Pregnant and breastfeeding women
Menopausal and postmenopausal
Smokers
Teeth with mobility greater than Grade 1
Patients with systemic comorbidities (e.g., Type 2 diabetes mellitus, hypertension)
Patients with a history of recent periodontal surgery
|
|
|
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. Clinical Attachment Level (CAL) Gain – Measured using a UNC-15 periodontal probe at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
2. Probing Pocket Depth (PPD) Reduction – Evaluated at the same time intervals to determine the extent of periodontal healing and reduction in periodontal pocket depth.
3. Radiographic Bone Fill – Assessed using Cone-Beam Computed Tomography (CBCT) to compare pre- and postoperative bone levels within intrabony defects.
|
All primary outcomes are measured at baseline, 3 months, and 6 months postoperatively to assess periodontal tissue regeneration.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early Soft Tissue Healing |
Evaluated using the Wound Healing Index (WHI) at 1st week, 2nd week, and 4th week postoperatively to assess the progression of soft tissue repair.
|
| Gingival Index (GI) |
Assessed to determine the degree of gingival inflammation tissue response at baseline, 3 months, and 6 months.
|
| Plaque Index (PI) |
Measured to evaluate biofilm accumulation and its impact on periodontal healing over time.
|
| Bleeding on Probing (BOP) |
Recorded at each follow-up visit to assess the degree of inflammation and vascular response |
| Bone Density Analysis |
Assessed via CBCT at baseline, 3 months, and 6 months to evaluate changes in bone quality and mineralization |
| Crestal Bone Loss Measurement |
Determined using standardized radiographic analysis to quantify marginal bone changes around the defect site. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
06/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/12/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - 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 - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [amandarebello.97@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 30-06-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Periodontal regeneration remains a significant challenge due to the limitations of conventional therapies, such as bone grafts and guided tissue regeneration, which often exhibit rapid resorption, unpredictable healing, and inadequate bioactive molecule release necessary for sustained tissue repair.
Platelet-rich fibrin (PRF), and autologous biomaterial, has shown promise in enhancing cellular migration, proliferation, and differentiation. However, conventional PRF lacks mechanical stability, degrades rapidly, and has inconsistent growth factor release, limiting its regenerative potential.
To address these limitations, Advanced Platelet-Rich Fibrin (A-PRF) and Albumin Platelet-rich fibrin (Alb-PRF) have been developed. Alb-PRF, in particular, offers enhanced fibrin network stability, prolonged degradation resistance, and sustained release of growth factors such as PDGF, TGF-beta, and VEGF, which are crucial for periodontal regeneration. The incorporation of albumin further strengthens the fibrin matrix, extending its bioactivity and resorption period, potentially leading to superior clinical outcomes.
Despite these advantages, there is limited comparative evidence on the clinical and radiological efficacy of Alb-PRF as compared with A-PRF in periodontal regeneration. This study aims to fill this gap by systematically evaluating and comparing their regenerative potential to Leucocyte Platelet-rich fibrin, the gold standard in periodontal regenerative therapy.
Additionally, cone-beam computed tomography (CBCT) will be utilized to provide precise, three-dimensional volumetric assessments of bone regeneration, offering greater accuracy than conventional radiographic findings.
The findings of this study will contribute to evidence-based periodontal therapy, potentially guiding the development of more effective biomaterial-based regenerative strategies. |