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CTRI Number  CTRI/2025/03/083026 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [non surgical]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Minimally Invasive Non-Surgical Therapy (MINST) and Conventional Non-Surgical Therapy (CNST) for Treating Periodontitis 
Scientific Title of Study   Comparative evaluation of two treatment modalities of minimally invasive non-surgical therapy (minst) with conventional non surgical therapy (cnst) in the treatment of periodontitis 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neha Shukla 
Designation  Post Graduate 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, 
Address  Department number 7 Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226001
India 
Phone  09304859785  
Fax    
Email  nehashuklatiger333@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amitabh Srivastava 
Designation  Professor and Head of the department 
Affiliation   
Address  Department number 7,Department of Periodontology, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Department of Periodontology,Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226001
India 
Phone  9415085343  
Fax    
Email  docamitabh74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amitabh Srivastava 
Designation  Professor and Head of the department 
Affiliation   
Address  Department number 7, Department of Periodontology Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow
Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow

UTTAR PRADESH
226001
India 
Phone  9415085343  
Fax    
Email  docamitabh74@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Postgraduate Institute of Dental and Medical Sciences , Lucknow, India, Pincode - 226029 
 
Primary Sponsor  
Name  Dr Neha Shukla 
Address  Sardar Patel Postgraduate oinstitute of dental and medical sciences, Lucknow, India, Pincode - 226029 
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 
DRNEHA SHUKLA  DEPARTMENT OF PERIODONTOLOGY  Sardar Patel Post Graduate Institute of Dental and Medical Sciences
Lucknow
UTTAR PRADESH 
9304859785

nehashuklatiger333@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: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional non surgical therapy  -The operating site will be anesthetised with 2% lignocaine with adrenaline in (1:80,000). -Debridement would be done using conventional curettes and ultrasonic scalers. The total duration of intervation is 30-45 mins. 
Comparator Agent  Laser assisted minimally invasive non surgical therapy  -The operating site will be anesthetised using topical anesthesia. -Initial debridement will be done using peizo-electric scaler with fine and delicate tips (G4 tip). -Thorough debridement will be done using mini curettes. -Then the diode laser will be used at power setting -1.5W and wavelength-970 nm in a continuous, contact mode having tip diameter of 200 microns10. -The tip will be inserted to the depth of the pocket and moved in apicocoronal direction with sweeping motion until removal of diseased tissue or maximum of 60 seconds per site. 
Comparator Agent  Minimally invasive non surgical therapy  The site to be treated will be anesthetised with 2% lignocaine without adrenaline using block and infiltration techniques. -Initial debridement would be done using peizo-electric scaler with fine and delicate tips (G4 tip). -Use of 3.5x loupes. -Thorough debridement will be done using mini curettes. -Soft tissue trauma should be minimised especially to the papilla, subpapillary access could be done and it should be tried to do no harm to the papilla present interdentally. -Attempt would be done to stimulate formation of stable clot 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patients.
2.Patients with age between 25-55 years
3.Patients diagnosed with generalised periodontitis having Probing depth -5mm and CAL - 3mm and indicated for non surgical periodontal treatment. 
 
ExclusionCriteria 
Details  1.The women who are pregnant/lactating.
2.Patients who required antibiotic treatment.
3.Patients who have taken antibiotic treatment in the last 3 months.
4.Patients who underwent with periodontal therapy in the last 6 months.
5.Patients who have the habit of smoking 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Minimally invasive treatment procedures may prove to be superior in term of healing and patient comfort. Use of Laser together with minimally invasive treatment procedure will have an added advantage in resolution of inflammation and pocket sterilization.   Baseline, 1 month , 3 month , 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   31/03/2025 
Date of Study Completion (India) 30/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Periodontitis is considered as a most prevalent condition and it is attributed by loss of attachment, formation of the periodontal pocket and the loss of bony structure. This is one of the major reasons for tooth loss. Factor like dental plaque can cause connective tissue loss with the loss of surrounding bone. Periodontitis has been categorized into various stages, on the basis of severity and also divided into various grades, based on progression of the disease. Reducing the bacterial load of periodontal pocket can be helpful in the treatment of periodontitis and it is attained by periodontal therapy and maintaining the periodontal health. Advanced disease may need surgical intervention or if the prognosis is hopeless, extraction of the involved tooth is advisable. The periodontal therapy can be non-surgical or surgical with the aim to improve clinical attachment, eliminate inflammation and reduce periodontal pocket depth (PD), resulting in decreased risk of progression of disease. Traditional non-surgical periodontal treatment includes, use of power-driven or manual instrumentation to clean the root surfaces. Although there are studies which states that some amount of calculus could be found after traditional therapy and that recession is unavoidable and more in severe cases of periodontitis so recently, minimally invasive non-surgical therapy(MINST) has been proposed to decrease trauma to the tissue and enhance overall outcome by the additional use of magnification and specifically made fine instruments. Magnification can be achieved with the use of loupes, microscopes, videoscopes. Loupes can be of different types based on the magnification range and can be simple or compound and prism in design. Minimally invasive therapy protocol involves the use of 3.5x loupes for magnification. MINST might prove as a good alternate to overcome the limitations of conventional periodontal therapy as, not only magnification but by the use of finer instruments this procedure becomes more effective and less traumatic than conventional treatment. Although, there are only some studies done to assess the efficacy of MINST comparing with the conventional non-surgical therapy in periodontal defects. 

Among the newer modalities, lasers in periodontal therapy are becoming common and the outcomes have been reported with overall positive results. Laser assisted minimally invasive non-surgical therapy aims at removal of granulation tissue and debridement without reflection of flap. This is an efficacious approach as a non-surgical treatment. In this study comparative evaluation and assessment between the MINST and Laser assisted MINST would be done among themselves and also with conventional nonsurgical therapy in order to observe superiority of one group over the another.  

 
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