| CTRI Number |
CTRI/2025/11/097232 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study aims to determine if albumin-enhanced PRF block can serve as a more biologically effective alternative to conventional guided tissue regeneration for regenerating bone in intrabony defects using a modified minimally invasive surgery approach. |
|
Scientific Title of Study
|
Comparative evaluation of conventional guided tissue regeneration to albumin-platelet rich fibrin block for the management of intrabony defects via modified-minimally invasive surgical technique:A clinicoradiographic study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoomika K V |
| Designation |
Post Graduate Student |
| Affiliation |
Bapuji Dental college and Hospital |
| Address |
Bapuji Dental college and hospital,
Department of Periodontology
Room no.5
MCC B block ,577004 davnagere
Davanagere
KARNATAKA
577004
India
Davanagere
KARNATAKA
577004
India |
| Phone |
8073655543 |
| Fax |
|
| Email |
bhoomikv01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raison Thomas |
| Designation |
Professor |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Bapuji Dental College and Hospital,
Department of Periodontology
Room no.5
MCC B block ,577004 Davangere
Davanagere
KARNATAKA
577004
India |
| Phone |
9886279018 |
| Fax |
|
| Email |
drrais79@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhoomika K V |
| Designation |
Post Graduate Student |
| Affiliation |
Bapuji Dental college and Hospital |
| Address |
bapuji dental college and hospital,
Department of Periodontology
Room no.5
MCC B block ,577004 davnagere
Davanagere
KARNATAKA
577004
India
Davanagere
KARNATAKA
577004
India |
| Phone |
8073655543 |
| Fax |
|
| Email |
bhoomikv01@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhoomika K V |
| Address |
Bapuji Dental college and hospital,mcc b block ,577004 davnagere |
| 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 |
| Bhoomika K V |
Bapuji dental college and hospital |
bapuji dental college and hospital,
Department of Periodontology
Room no.5
mcc b block ,577004 davnagere
Davanagere
KARNATAKA
577004
India
Davanagere
KARNATAKA |
08073655543
bhoomikv01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board |
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 |
Albumin-PRF block using M-MIST. |
To obtain the Alb-PRF block, blood will be collected from the centre cubital vein in the 9ml S-PRF tube without any additive. Following collection, it will be put in the centrifuge with a water-filled tube to keep the balance while centrifuging for eight minutes at 2700 rpm (~700 x g). For ten minutes, the syringe containing platelet deficient plasma (PPP) will be heated to between 70 and 75 degrees Celsius. The syringe will be allowed to cool for an additional ten minutes at room temperature following the completion of the heating process. Next, the cooled albumin gel will be combined with liquid PRF (i-PRF), which includes the remaining cells and growth factors present in the buffy coat layer, to create Alb-PRF. After mixing, the finished product will be placed in a glass container and blended gently with tweezers. By combining chopped Alb-PRF membrane with particulate bone graft (Xenograft), an Alb-PRF block will be produced. The block that forms after the fibrin polymerization process (about five minutes) has been identified as an Alb-PRF block. |
| Intervention |
Conventional GTR using M-MIST |
An entrance horizontal internal bevel incision will be made buccally at the base of the interdental papilla using a 15C blade. Without affecting the nearby papillae, intrasulcular incisions will be used to connect the interdental incision to the buccal face of the teeth that border the defect. Minimal elevation of a triangular buccal flap will be performed by carefully dissecting the gingiva in order to reveal the remaining buccal bony crest without any reflection of the affected papilla. Following the buccal reflection, the supracrestal interdental tissue will be separated from the granulation tissue using a 15C blade aimed at the buccal surface of the lingual bone wall. Curettes will subsequently be used to eliminate the granulation tissue. The root surface will undergo extensive scaling and root planing. Following M-MIST preparation, a particulate bone graft material (Xenograft) will be used and the intrabony defects will be covered with a resorbable collagen membrane after the defect has been filled. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy subjects who are not disqualified for periodontal surgery.
2.Subjects with good oral hygiene.
Site specific:
1. Individuals with radiographic evidence of bone defect (2 wall/3 wall/Grade II furcation involvement) and localized Stage III Grade B periodontitis.
2. In addition to having an intrabony 2 or 3wall defect of 4–7 mm, subjects should have a clinical attachment level and probing depth more than 4 mm.
|
|
| ExclusionCriteria |
| Details |
1.Individuals who smoke more than ten cigarettes a day as a chronic smoker.
2. Individuals who are unavailable for additional testing.
3. Pregnant and nursing mothers as subjects.
4. Participants who, within the previous six months, had received any kind of surgical periodontal therapy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage changes in defect fill, alveolar crest ,defect width, defect angle |
at baseline and 4 months after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque Index, Gingival Index, probing depth of the pocket, clinical attachment level |
at baseline and 4 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/11/2026 |
| 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="0"
Months="9"
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
|
The main objective of periodontal regeneration is to encourage the formation of new bone and create a new cementum with the periodontal ligament (PDL) fiber connected to the alveolar bone. The process of restoring periodontal tissue by utilizing a membrane that acts as an occlusive barrier between PDL tissue and gingival and alveolar bone. GTR is thought to be the ideal approach for preventing the migration of connective and epithelial tissues through the site of surgery. Platelet-rich fibrin (PRF), an autologous platelet concentrate contains several growth factors that are essential for better wound healing. The success of autologous platelet concentrates in some surgical operations may be hampered by restrictions in fibrin mesh in vivo lifetime, despite the fact that different regimens are designed for particular therapeutic applications. A method for creating albumin-enriched platelet-rich fibrin was developed to overcome this restriction. As far as we are aware, till date no study has been done to compare and assess the clinical and radiographic aspects of conventional GTR against Alb-PRF block using M-MIST technique in the management of intraosseous discrepancies in the periodontal region in patients with localized stage III grade B periodontitis |