| 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
|
|
|
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
|
|
|
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. |