FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073429 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the clinical outcomes of minimally invasive surgical procedures; minimally invasive surgical technique (MIST) and modified minimally invasive technique (M-MIST). 
Scientific Title of Study   COMPARISION OF CLINICAL EFFICACY OF MINIMALLY INVASIVE SURGICAL TECHNIQUE (MIST) VERSUS MODIFIED- MINIMALLY INVASIVE SURGICAL TECHNIQUE (M-MIST) IN THE TREATMENT OF PERIODONTAL INFRABONY DEFECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Syeda Sumayya Mazhar 
Designation  Junior Resident 
Affiliation  Department of Periodontia and community dentistry 
Address  Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  9634538950  
Fax    
Email  syedasumayya01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ND Gupta 
Designation  Professor 
Affiliation  Department of Periodontia and community dentistry 
Address  Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  9412817009  
Fax    
Email  ndguptaligarh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saif Khan 
Designation  Assistant Professor 
Affiliation  Department of Periodontia and community dentistry 
Address  Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Dr. Ziauddin Ahmad Dental College and Hospital A.M.U. Aligarh
Aligarh
UTTAR PRADESH
202002
India 
Phone  9012875280  
Fax    
Email  skhan.pu@amu.ac.in  
 
Source of Monetary or Material Support  
Department of Periodontia and community dentistry, Dr. Ziauddin Ahmad dental college A.M.U. Aligarh 202002, Uttar Pradesh, India. 
 
Primary Sponsor  
Name  Department of Periodontia and Community dentistry 
Address  Dr. Ziauddin Ahmad dental college A.M.U. Aligarh 
Type of Sponsor  Other [Government dental college] 
 
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 Syeda Sumayya Mazhar  Dr Ziauddin Ahmad Dental College and Hospital  Department of Periodontia and community dentistry A.M.U.
Aligarh
UTTAR PRADESH 
9634538950

syedasumayya01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K05||Gingivitis and periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Minimally invasive surgical technique (MIST) with i-PRF.  MIST is based on the elevation of the defect associated interdental papilla along with minimally extended buccal and lingual flap; with use of injectable platelet-rich fibrin (i-PRF). 
Intervention  Modified Minimally invasive surgical technique(M-MIST) with i-PRF.  M-MIST is based on the elevation of only buccal flap, which enhances the concept of MIST by avoiding the interdental papilla as well as palatal flap dissection and elevation; with the use of injectable platelet-rich fibrin (i-PRF). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  periodontitis (stage III-IV)
Systematically healthy patient
Contained infrabony defects 
 
ExclusionCriteria 
Details  Patients who had received periodontal treatment within the previous three months.
Pregnant or lactating
Third molars
Teeth with grade III mobility 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical outcomes in terms of pocket probing depth (PPD) reduction, clinical attachment level (CAL) gain and bone fill (BF) in the treatment of periodontal infrabony defects.  Final clinical and radiographic outcomes will be evaluated at 6 months follow-up.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the early healing index of periodontal soft tissue wounds after the surgery.
2. To quantify radiographically, regeneration of interdental bone using CBCT.
3. To compare the clinical, radiological and patient centered outcomes of minimally invasive surgical technique (MIST) with the modified minimally invasive surgical technique (M-MIST).  
Subjects will be recalled after 7 days for evaluation of early wound healing index; at 3 months for soft tissue evaluation, and then the final clinical and radiographic outcomes will be evaluated at 6 months follow-up.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   16/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Minimally invasive surgery (MIS)/ minimal access surgery (MAS) was introduced with the aim to produce minimal wounds, minimal flap reflection and gentle handling of the soft tissues.
Minimally invasive surgical technique (MIST) is based on the elevation of the defect-associated interdental papilla along with minimally extended buccal and lingual flaps. The Modified-MIST is based on elevation of only buccal flap, further enhances the concept of MIST by avoiding the interdental papilla as well as palatal flap dissection and elevation.
Minimally invasive surgical technique (MIST) focuses on wound and blood clot stability and primary wound closure for clot protection. This regeneration is possible with reduced patient morbidity, and unaesthetic results are minimized or eliminated. Modified minimally invasive surgical technique (M-MIST) incorporated the concept of space provision for regeneration.
In the field of regeneration, there are barrier membranes, grafts, and wound healing modifiers alone or in combinations. Noteworthily, dimensional changes of alveolar bone following tooth loss have remained a prominent challenge for the clinician and a variety of regenerative procedures have since been utilized. One such proposed method has been the use of platelet concentrates, platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (iPRF) which both uses supra-physiological doses of autologous growth factors derived from the patient’s own blood further capable of speeding tissue regeneration.
A major problem to overcome applying minimally invasive surgery is the problem of visibility and manipulation of surgical field. High magnification and direct optical illumination provided by a surgical microscope or loupes can be of great help. Also, soft tissue manipulation during instrumentation requires special care. Small instruments like small periosteal elevators, tiny forceps, mini curette are mandatory for gentle manipulation of hard and soft tissues.

 
Close