| CTRI Number |
CTRI/2018/07/015142 [Registered on: 31/07/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Dentistry |
| Study Design |
Other |
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Public Title of Study
|
Effectiveness of platelet concentrate, bone graft when used with or without diode laser application in the management of root canal treated lower jaw bifurcation defects |
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Scientific Title of Study
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Combined effectiveness of platelet rich fibrin and bone graft in the management of endodontically treated mandibular grade II furcation defects when used with or without diode laser. A Randomized controlled
clinical trial |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLIED |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navjot Kaur |
| Designation |
Post Garduate Student Perioodontology |
| Affiliation |
Department of Periodontology |
| Address |
Department of Periodontology
Surendera dental college and research institute
His higness gardens
Sriganganagar
Ganganagar RAJASTHAN 335001 India |
| Phone |
8054844677 |
| Fax |
01542440102 |
| Email |
brar.navjotkaur@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SANJEEV KUMAR SALARIA |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
Surendera Dental College and Reasearch Institute |
| Address |
Department of Periodontology and oral implantology
Surendera Dental College and Reasearch Institute
His highness Gardens
Power House road Sriganganagar
Ganganagar RAJASTHAN 335001 India |
| Phone |
8740834848 |
| Fax |
01542440102 |
| Email |
sksalaria@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Navjot Kaur |
| Designation |
Post Garduate Student Ist year |
| Affiliation |
Surendera Dental College and Reasearch Institute |
| Address |
Department of Periodontology
Surendera Dental College and research institute
His highness Gardens
Power House road Sriganganagar Department of Periodontology
A Block, first floor
Room No 4
Ganganagar RAJASTHAN 335001 India |
| Phone |
8054844677 |
| Fax |
01542440102 |
| Email |
brar.navjotkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Navjot Kaur
Post graduate student
Department of Periodontology
Surendera dental college
Sriganganagar |
|
|
Primary Sponsor
|
| Name |
Dr Navjot Kaur |
| Address |
House no 2456
Ward no 6
Near rock star hotel
Moga
Punjab
|
| Type of Sponsor |
Other [self] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navjot kaur |
Surendera dental college and research institute |
Department of periodontology
A Block
First floor
Room No 4 Ganganagar RAJASTHAN |
8054844677 01542440102 brar.navjotkaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Surendera Dental College and Research Institute |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Management of endodontically treated mandibular grade II furcation defects, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DIODE LASER |
After open periodontal flap debridement of furcation defects half of the furcation defects irradiated with 980 nm diode laser at 2 W for 10 second followed by restoration of furcation defects by amalgamated graft of Platelet rich fibrin and freeze dried irradiated demineralized bone granues where as in rest of furcation defects no diode laser irradiation done but rest of the procedure is same. |
| Intervention |
Periodontal regenerative flap surgery |
After open periodontal flap debridement of all the furcation defects filled with amalgamated graft of Platelet rich fibrin and freeze dried irradiated demineralized bone granules |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Systemically healthy subjects (aged 20 and 55 years) with minimal twenty mandibular Grade II molar furcation defects in endodontically treated teeth by radiographic and clinical evidence.
2 Persistent clinical vertical probing depths (VPD) ≥ 5 mm with horizontal probing depth (HPD) ≥ 3 mm.
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| ExclusionCriteria |
| Details |
1. Subjects with poor oral hygiene maintenance.
2. Subjects with a habit of smoking or use of other tobacco products.
3. Subjects with systemic diseases for example diabetes mellitus, hypertension, hepatitis, HIV etc known to complicate the outcome of periodontal therapy.
4. Use of antibiotics during the previous two months and no long-term treatment with non steroidal anti-inflammatory drugs (NSAIDS).
5. Pregnant and lactating women.
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1 Vertical probing depth
2 Horizontal probing depth from the gingival margin (GML).
3 Relative vertical clinical attachment level (RV-CAL)
4 Relative horizontal clinical attachment level (RH-CAL)
5 Radiographic evaluation of the furcation defect size in IOPA with radiographic grid utilizing parallel profile radiographic technique
|
All the parameters to be evaluated at
1 Baseline
2 3rd month post operatively
3 6th month post operatively |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1 Turesky-Gilmore -Glickman modification of the Quigley Plaque index.
2 Modified Sulcus bleeding index
|
both secondary paratmeters to be evaluated at
1 baseline
2 3rd month post operatively
3 6th month post operatively |
|
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/12/2016 |
| Date of Study Completion (India) |
28/07/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="9" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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The periodontal disease is a chronic inflammatory process, characterized by microbial etiology and cyclic evolution which determines a progressive, site-specific destruction of the supporting tissues of the tooth and proceeds from the superficial (gingiva) to the deep periodontium (alveolar bone, periodontal ligament, cementum), resulting in typical pathological lesions (periodontal pockets, gingival recessions, vertical and/or horizontal bone resorption, bi or tri furcation lesions etc) to the loss of the dental element.1 According to American Academy of Periodontology furcation lesion is defined as the pathologic resorption of bone in the anatomic area of multirooted tooth/teeth where the roots diverge as cited in the report of Sanz M et al2 and was further classified as grades I to IV by Irving Glickman in 1953. Different regenerative approaches have been proposed for management of furcation involvement: Guided tissue regeneration, enamel matrix derivatives, bone substitutes like autogenous bone graft, alloplast, autograft etc. but the complete closure of furcation defects is unpredictable because of multiple reasons such as narrow furcation area, root approximation, cervical enamel projections, ridges, convexities and concavities on root surface that frequently render the defect impossible to instrument effectively. Therefore, furcation defects represent a formidable problem in the treatment of periodontal diseases.3 Different studies showed variable results as few suggested partial regeneration of grade II furcation defects in vital teeth when treated by PRF alone3 or in combination with bone graft4 whereas reports of Salaria SK et al5,6 in endodontically treated non vital tooth showed complete regeneration when treated with combination of PRF and bone graft. In spite of different periodontal regenerative approaches, as currently, not a single regenerative material is considered gold standard in the treatment of osseous defects.6 Currently, Choukroun’s Platelet-rich fibrin(PRF) and Diode laser attracted lot of attention of various researchers because of their distinctive properties. Choukroun’s PRF is enriched with platelets, cytokine and growth factors when used as membrane or as grafting material creates an improved space making effect which, facilitates cell event that are favourable for periodontal regeneration leading to mineralized tissue formation,7 it also induces the cell proliferation of osteoblasts, periodontal ligament cells, growth factors, but suppress the oral epithelial cell growth,8 thereby improving the soft and hard tissue healing. Laser have several potential benefits such as antibacterial effect, stimulation of wound healing, haemostasis and delayed epithelial migration which may facilitate the outcome of flap surgery.9 To the best of our knowledge, the use of PRF, bone graft with or without Diode Laser in the management of grade II furcation defects in endodontically treated teeth are scarce in literature. Therefore, the present study was designed to evaluate the combined effectiveness of PRF and bone allograft in the management of endodontically treated mandibular grade II furcation defect when used with or without Diode Laser.
LIST OF REFERENCES:
Crispino A, Figlizzi MM, Lovane C, Guidice TD, Lomanno S, Pacifico D et al. Effectiveness of diode laser in addition to non-surgical periodontal therapy:study of intervention. Ann Stomatol 2015;6:15-20. Sanz M, Jepsen K, Eickholz P, Jepsen S. Clinical concepts for regenerative therapy in furcations. Periodontol 2000 2015;68:308-32. Sharma A, Pradeep RA. Autologous platelet rich fibrin in the treatment of mandibular degree II furcation defect: A randomized clinical trial. J Periodontol 2011;82:1396-1403. Lafzi A, Shirmohammadi A, Faramarzi M, Jabali S, Shayan A. Clinical Comparison of Autogenous Bone Graft with and without Plasma Rich in Growth Factors in the Treatment of Grade II Furcation Involvement of Mandibular Molars. J Dent Res Dent Clin Dent Prospects 2013;7:22-9. Salaria SK. Chahal NK, Chahal SS, Singh P. Single flap approach with lingual access in conjugation with PRF and Biograft HABG in the management of residual Grade II furcation defect occurring from primary endodontic and secondary periodontal lesion. A case report. J Pharma Biomed Sci 2016;6:18-22. Salaria SK, Ghuman SK, Kumar S, Sharma G. Management of localized advance loss of periodontal support associated grade II furcation and intrabony defect in chronic periodontitis patient through amalgamation of platelet rich fibrin and hydroxylapatite bioactive glass composite granules. Contemp Clin Dent 2016;7:405-8. Diss A, Dohan DM, Mouhyi J, Mehlar P. Osteotome sinus floor elevation using Choukroun’s platelet rich fibrin as grafting material: A 1 year prospective pilot study with microthreaded implants. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2008;105:572-9. Tsai CH, Shen SY, Zhao JH, Chang YC. Platelet rich fibrin modulates cell proliferation of human periodontal related cells in vitro reports. J Dent Sci 2009;4:130e5. Lobo TM, Pol DG. Evaluation of the use of 940 nm diode laser as an adjunct in flap surgery for treatment of chronic periodontitis. J Ind Soc Periodontol 2015;19:43. de Andra AK, Feist IS, Pannuti CM, Cai S, Zezell DM, Micheli G. Nd YAG laser assisted in class II furcation treatment. Lasers Med Sci 2008;23:341-7.
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