| CTRI Number |
CTRI/2024/07/071401 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Probiotic Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing injectable platelet rich fibrin with allograft and amniotic membrane with probiotics with allograft and amniotic membrane in intrabony defects using papilla preservation approach |
|
Scientific Title of Study
|
Role of injectable platelet rich fibrin and allograft with amniotic membrane vs probiotic and allograft with amniotic membrane in intrabony defects using nonincised papillae surgical approach- A randomized clinical 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 |
DrKRekha Rani |
| Designation |
Head of the Department |
| Affiliation |
Panineeya Mahavidyalaya Institute of dental sciences and research centre |
| Address |
Room no 101 ,Department of Periodontics
Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,
Hyderabad TELANGANA 500060 India |
| Phone |
9885160094 |
| Fax |
|
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrKRekha Rani |
| Designation |
Head of the Department |
| Affiliation |
Panineeya Mahavidyalaya Institute of dental sciences and research centre |
| Address |
Room no 101 ,Department of Periodontics
Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,
Hyderabad TELANGANA 500060 India |
| Phone |
9885160094 |
| Fax |
|
| Email |
rekhasarat2304@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
KVidya Pranathi |
| Designation |
Post Graduate |
| Affiliation |
Panineeya Mahavidyalaya Institute of dental sciences and research centre |
| Address |
Room no 101 ,Department of Periodontics
Panineeya Mahavidyalaya Institute of dental sciences and research centre, road no 5, Kamalangar Dilsuknagar,Hyderabad,
Hyderabad TELANGANA 500060 India |
| Phone |
8341083583 |
| Fax |
|
| Email |
vidya.pulla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panineeya Mahavidyalaya Institute of Dental Sciences and research centre
Road no 5
Kamala nagar
Dilshuknagar
Hyderabad
Telangana
500065
India |
|
|
Primary Sponsor
|
| Name |
Panineeya Mahavidyalaya Institute of Dental Sciences and research centre |
| Address |
Road no 5
Kamala nagar
Dilshuknagar
Hyderabad
Telangana 500065
India |
| 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 |
| DrKVidya Pranathi |
Panineeya Mahavidyalaya Institute of Dental Sciences and Research Centre |
Room no 101
Department of Periodontics
Road no 5
Kamalanagar
Dilshuknagar Hyderabad TELANGANA |
8341083583
vidya.pulla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1- 11
iPRF +allograft +amniotic membrane |
Injectable Platelet rich fibrin with allograft and amniotic membrane using Non Incised Papilla Surgical Approach (NIPSA) in Intrabony defects |
| Comparator Agent |
Group 2-11
Probiotic +allograft +Amniotic Membrane |
Probiotics with allograft and amniotic membrane using Non Incised Papilla Surgical Approach (NIPSA) in Intra bony defects |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Patients aged ≥ 20 years with Stage III periodontitis
• Patient having at least one tooth with intra bony defect ≥3mm {two wall or combined two to three walled intraosseous defect} (assessed by trans-gingival probing, radiographic examination)
• CAL≥ 5mm
• PD ≥6 mm.
|
|
| ExclusionCriteria |
| Details |
• Any systemic disease that contra-indicates periodontal surgery or may affect healing.
• Smokers
• Pregnant and lactating mothers
• History of intake of antibiotics or other medications affecting the periodontium in the previous 6 months.
• Surgical periodontal therapy carried out in the past 6 months.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Probing pocket depth(PPD)
• Clinical Attachment level(CAL)
• Bone fill assessed by CBCT
|
Baseline and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Recession depth (RD)
• Location of the tip of the papilla (LTP)
• Wound closure (WC) |
Baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="22" Sample Size from India="22"
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)
|
06/08/2024 |
| 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="6" 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
|
• Periodontitis is a chronic inflammatory disorder, associated with a dysbiotic plaque biofilm, resulting in progressive destruction of the tooth-supporting apparatus and intra bony periodontal defects. Intraosseous defects are a frequent sequelae of periodontitis and when left untreated may significantly affect the long-term success of the affected teeth. • Conventional periodontal surgery results in reduction of the pocket depth, elimination of osseous defects but may also be associated with considerable loss of the tooth supporting tissue including the papillae. To overcome these problems along with associated postoperative pain, bleeding, swelling, root hypersensitivity and delayed healing, several minimally invasive and papilla preservation techniques have been employed. The non-incised papilla surgical approach (NIPSA) is one such papilla preservation technique which was developed with the aim of achieving clinical improvements compared with marginal access • techniques. In NIPSA an apical approach is carried out, without incisions of tissues at the level of the papillae or marginal tissues, thereby preserving the interproximal tissues which aid in retention of clot in the underlying defect and prevent collapse of marginal tissues. • Demineralized freeze-dried bone allograft (DFDBA) is osseoinductive and harbours a variety of growth/differentiation factors, bone morphogenetic proteins (BMPs) and is inferred to promote periodontal repair/regeneration, with significant probing pocket depth (PPD)-reduction, clinical attachment level (CAL)-gain and bone fill. It was proposed that mixing I-PRF(injectable platelet rich fibrin) with bone grafts, forming a fibrin-graft-amalgamate , enhanced the graft’s biological properties, handling and stability • Injectable platelet-rich fibrin (I-PRF) is the most recent and successful advancement in PRF. It is a liquid autologous platelet concentrate created by low-speed centrifugation concept and omitting the formation of a PRF membrane. It harbours a variety of growth/differentiation factors (GFs),promotes angiogenesis, traps circulating stem cells, induces collagen synthesis, and stimulates the growth of fibroblasts and osteoblasts as well as the prolonged delivery of growth factors to the area where a wound is present. Probiotics are live cultures of microorganisms that confer a health benefit by exerting a biological response in the host when administered in adequate amounts. They have been proposed for as a possible alternative to standard antimicrobial adjuvants in periodontitis where scaling and root planing therapy alone is not successful. It is suggested that they are able to induce changes in the structure of the bacterial community, which could lead to changes in interbacterial interactions, decrease the virulent periodontopathogens, modulate the immune response of the host and restore the balance of the oral ecosystem . • Amniotic membrane serves as a fibrillar scaffold and serves as a reservoir of stem cells, modulates angiogenesis and promote wound healing .The presence of the non-collagenous proteins in the amniotic membrane makes it superior to the collagen membrane as these proteins serve to modulate the cell behaviour in wound healing. It has been suggested combining the use of bone grafts with the barrier membrane to obtain a synergistic effect termed as Combined Periodontal Regenerative Therapy (CPRT ).
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