| CTRI Number |
CTRI/2024/03/063595 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of Bone Loss with Bone Graft. |
|
Scientific Title of Study
|
Comparative evaluation of demineralized freeze dried
bone allograft with and without PRF membrane in the
treatment of periodontal intrabony defects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarita Parihar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no.5, Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8004925677 |
| Fax |
|
| Email |
saritaparihar@bhu.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Sarita Parihar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no.5,Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8004925677 |
| Fax |
|
| Email |
saritaparihar@bhu.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Sarita Parihar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Room no. 5, Division of Periodontology,Faculty of dental sciences,IMS,BHU,Varanasi
Varanasi UTTAR PRADESH 221005 India |
| Phone |
8004925677 |
| Fax |
|
| Email |
saritaparihar@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Faculty of dental sciences,IMS,BHU,Varanasi |
|
|
Primary Sponsor
|
| Name |
Sarita Parihar |
| Address |
Unit of periodontology,Faculty of dental sciences,IMS,BHU,Varanasi |
| Type of Sponsor |
Other [self sponsoring] |
|
|
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 Sarita Parihar |
Faculty of dental sciences |
Room number 5,Division of Periodontology, department-Faculty of dental sciences,Institute of medical sciences,Banaras Hindu University Varanasi UTTAR PRADESH |
8004925677
saritaparihar@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Institute of medical sciences,Banaras Hindu University |
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 |
DFDBA in periodontal intrabony defects |
changes are observed before the surgical procedure and after 6 months |
| Intervention |
DFDBA with PRF membrane in periodontal intrabony defects |
Patients autologous blood is withdrawn and centrifuged to make PRF membrane.
Changes are observed before the surgical procedure and after 6 months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with moderate to severe periodontitis with a probing depth (PD) ≥5mm & Intrabony
component of ≥3 mm as detected on IOPA x-ray & bone sounding.
2.Healthy individual willing for study with no systemic diseases that will influence the outcome of
therapy.
3.Not using tobacco in any form.
4. Able to achieve good oral hygiene.
5. Subjects who gave written consent.
6. Subjects who were available for follow up
|
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients with presence of any systemic disease.
2. Pregnant & Lactating women.
3. Patients taking any medication.
4. Teeth with one wall defects, furcation involvement & mobility.
5. Hypersensitivity or allergy to allograft based medical products.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Changes in PPD (Periodontal Probing Depth)
• CAL (Clinical Attachment Level)
• Radiographic bone gain
|
Baseline and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in position of Gingival margin
Plaque Index
Gingival index
|
Baseline and after 6 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
25/03/2024 |
| 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="8" 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
|
Periodontal therapy aims to arrest disease
progression and regeneration of structures lost to disease. Periodontal
regeneration requires a sequence of cell migration, adherence, growth and
differentiation, which have potential to increase regeneration.To be considered
a regenerative modality, a material or technique must demonstrate that bone,
cementum and a functional periodontal ligament can be formed on a diseased root
surface.
Various bone materials such as autogenous
grafts, demineralised freeze-dried bone allografts, bovine bone xenografts, or
synthetic bone substitutes have demonstrated regenerative potential and have
been successfully used in the treatment of intrabony defects. The use of
demineralised freeze-dried bone allografts (DFDBA), whether alone or in
combination with other treatment modalities for periodontal therapy, has
repeatedly demonstrated significant improvements in both soft and hard clinical
tissue parameters.Although complete periodontal regeneration is unpredictable
with any regenerative therapy currently used, periodontal bone grafts show
strong potential. A large body of clinical evidence clearly indicates that
grafts consistently lead to better bone fill than non-grafted controls. DFDBAs
have repeatedly demonstrated significant improvements in soft and hard clinical
tissue parameters for the treatment of intraosseous periodontal defects.
Substances present in the demineralized bone graft material, i.e., bone
morphogenic proteins, stimulate local cell cycles to produce new bone. The
freeze drying process destroys cells while maintaining cellular morphology and
chemical integrity. These two factors, in conjunction with other materials,
enhance periodontal regeneration and/or bone fill.
In periodontology, platelet-rich fibrin
(PRF) has become a useful add-on therapy with the goal of accelerating
periodontal tissue regeneration and repair. PRF is a concentrated form of
platelets, growth factors, and cytokines, an autologous preparation made from
the patient’s own blood. Due to its distinctive makeup, PRF can successfully
encourage tissue regeneration and healing after a variety of periodontal
procedures. It can enhance the results of treatments like guided tissue
regeneration and bone grafting by acting as a natural scaffold to assist with
the growth of new bone and connective tissue. PRF has been shown to accelerate
soft tissue healing, lessen postoperative pain, and reduce swelling and
inflammation. Its use in procedures including implant placement, gingival
recession coverage, and flap surgeries have demonstrated enhanced wound healing
and aesthetic results. The ability of PRF to create an advantageous milieu rich
in cytokines and growth factors aids in improving the results of different
periodontal procedures.
Therefore, the purpose of this study was to
compare clinical and radiographic outcomes obtained with combination of PRF and
DFDBA to those obtained with DFDBA alone in treatment of periodontal intrabony defects .
|