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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 
Type of Study   Dentistry 
Study Design  Other 
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 
Scientific Title of Study   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   
Secondary IDs if Any  
Secondary ID  Identifier 
NOT APPLIED  NIL 
 
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] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Management of endodontically treated mandibular grade II furcation defects,  
 
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  
 
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.
 
 
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.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
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 
 
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 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
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 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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:


  1. 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.

  2. Sanz M, Jepsen K, Eickholz P, Jepsen S. Clinical concepts for regenerative therapy in furcations. Periodontol 2000 2015;68:308-32.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

     

  10. 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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