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CTRI Number  CTRI/2023/08/056629 [Registered on: 18/08/2023] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of bone fill in bony defect around tooth using self blood product vs without any material 
Scientific Title of Study   Clinical and radiographic outcomes of the modified minimally invasive surgical technique with or without platelet rich fibrin for the treatment of intrabony defects : a randomized clinical trial 
Trial Acronym  M-MIST technique with or without PRF for intrabony defects treatment 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Peri srivani 
Designation  post graduate student 
Affiliation  SCB Dental College and Hospital 
Address  Dept of periodontics SCB dental college and Hospital mangalabag Cuttack

Cuttack
ORISSA
753007
India 
Phone  8763516008  
Fax    
Email  peri.srivani.96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Neelima Kaatti 
Designation  Assistant Professor 
Affiliation  SCB Dental College and Hospital 
Address  Dept of periodontics SCB dental college and Hospital mangalabag Cuttack

Cuttack
ORISSA
753007
India 
Phone  9337613446  
Fax    
Email  kattineelima@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Peri srivani 
Designation  post graduate student 
Affiliation  SCB Dental College and Hospital 
Address  Dept of periodontics SCB dental college and Hospital mangalabag Cuttack

Cuttack
ORISSA
753007
India 
Phone  8763516008  
Fax    
Email  peri.srivani.96@gmail.com  
 
Source of Monetary or Material Support  
SCB Dental College and Hospital, Mangalabag, Cuttack-753007, Cuttack, Odisha 
 
Primary Sponsor  
Name  not applicable 
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 
Peri Srivani  SCB Dental College and Hospital  3rd floor, Dept of Periodontics, SCBDCH Mangalabag cuttack
Cuttack
ORISSA 
8763516008

peri.srivani.96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SCB DENTAL COLLEGE AND HOSPITAL, CUTTACK  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A488||Other specified bacterial diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  M-MIST technique with PRF  PRF is considered a second-generation platelet concentrate; it has trimolecular fibrin morphology with a 74% composition of leukocytes, and is known to have osteoconductive, immunomodulatory, and neo-angiogenic properties. In vitro studies have demonstrated that PRF acts as a scaffold for the culture of human periosteal cells and can be applied in bone tissue engineering. Furthermore, it releases autogenous growth factors gradually and manifests a stronger effect on the proliferation and differentiation of osteoblasts.Clinical studies have also demonstrated convincing results of PRF in achieving periodontal regeneration in intrabony defects. It will take around 6 months for visualising the effects of PRF 
Comparator Agent  only M-MIST surgical technique  None 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1)25 years of age or older.
2)Stage II or III Periodontitis
3)Presence of at least a single site with PPD and clinical attachment level (CAL) ≥5 mm on the buccal surface associated with a 3-walled osseous defect depth of ≥3 mm bilaterally or in both maxillary and mandibular arches.
4)Adequate width of attached gingiva,
5)Plaque index < 30 %
 
 
ExclusionCriteria 
Details  1)Previous periodontal surgery within the last 6 months in area of interest.
2)Systemic conditions which are generally considered to be a contraindication to periodontal surgery.
3)Pregnant or lactating females
4)Current or former smokers.
5)Hopeless tooth.
6) Patients on systemic medications such as corticosteroids or Calcium channel blockers or taking long-term NSAIDS or taking bisphosphonates or calcium supplements.
7)patients who had periodontal sites with fractured and perforated roots
8) teeth with grade III mobility and furcation involvement
9) non-vital tooth with or without periapical pathology
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
change in clinical attachment level and radiographic Defect depth reduction % from baseline to 6 months postoperative  baseline to 6 months postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
Probing pocket depth
plaque index
modified sulcular bleeding index
Early wound healing score
patient VAS 
0,3 month, 6 month 
 
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)   28/08/2023 
Date of Study Completion (India) 15/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/11/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [peri.srivani.96@gmail.com].

  6. For how long will this data be available start date provided 31-12-2022 and end date provided 28-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Periodontitis results in increased pocket depth, intrabony defects, gingival recession, tooth mobility, furcation involvement. Intrabony defect is defined as periodontal defect surrounded by one, two or three bony walls or a combination of thereof. Various regenerative materials are incorporated into the intrabony defects by open flap debridement and guided tissue regeneration. In conventional surgical approach ,large flaps are raised to completely and exceedingly expose the area of interest and the results were unsatisfactory due to limited regenerated periodontal tissue. Thus, an alternative approach to access the intra-bony defects was proposed. This approach is called minimally invasive surgical techniques which uses incisions just large enough for debridement and generally involves reflecting the papilla only by using specialized instruments to access the intra-bony defect.

 

The introduction of operative microscopes and microsurgical instruments resulted in increased surgical effectiveness by improving the visual acuity & accuracy and better control of the surgical instruments resulting in reduced flap reflection. Following the principles of papilla preservation flap, Cortellini and Tonetti recommended the use of the minimally invasive surgical technique (MIST) with microsurgical instruments and operating microscope that demonstrated better healing in terms of  significant gain in attachment level, pocket depth reduction, and minimal gingival recession in the treatment of isolated deep intrabony defects.

 

The Modified-MIST (M-MIST) was introduced by Cortellini & Tonnetti to reduce surgical invasiveness by limiting the incision line to the buccal side. This fulfilled the following objectives: (i) to maintain the interdental papillary height by minimizing its tendency to collapse; (ii) to increase the likelihood of primary wound closure; (iii) to reduce the chances of gingival recession; (iv) to improve flap stability; (v) to maintain space for regeneration; (vi) reduce patient morbidity (vii) better ergonomics.

 

Various randomised controlled clinical trials have been conducted to study the efficacy of M-MIST in the treatment of intrabony defects with and without regenerative materials such as enamel matrix derivative (EMD), bone mineral derived xenograft (BMDX), and recombinant human platelet derived growth factor (rhPDGF). Very few clinical trials have been attempted to study the use of M-MIST with autologous platelet-rich-fibrin (PRF).

 

PRF is considered a second-generation platelet concentrate; it has trimolecular fibrin morphology with a 74% composition of leukocytes, and is known to have osteoconductive, immunomodulatory, and neo-angiogenic properties. In vitro studies have demonstrated that PRF acts as a scaffold for the culture of human periosteal cells and can be applied in bone tissue engineering. Furthermore, it releases autogenous growth factors gradually and manifests a stronger effect on the proliferation and differentiation of osteoblasts. Clinical studies have also demonstrated convincing results of PRF in achieving periodontal regeneration in intrabony defects, class II furcation defects, coronally advanced flaps with multiple gingival recession, and sinus augmentation during implant placement.

 

Considering the benefits of PRF for augmenting bone and soft tissue healing, it is hypothesized that PRF could act as an adjunct to M-MIST, potentially yielding better results than M-MIST alone in the treatment of isolated intrabony defects. Thus, the aim of this study is to observe the outcomes of periodontal surgery in which M-MIST is used with or without PRF for the treatment of isolated intrabony defects.

 
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