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CTRI Number  CTRI/2025/07/091516 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 23/07/2025
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 minimal access non-surgical with minimal access surgical procedure to treat gum disease having bone loss around tooth: A clinical study 
Scientific Title of Study   Comparative clinical and radiographic evaluation of Minimally invasive non-surgical and Minimally invasive surgical therapy in treatment of periodontal intra-bony defect: A randomized clinical trial 
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 Gauri Ugale  
Designation  professor  
Affiliation  Maharashtra institute of dental sciences and research dental college Latur 
Address  room no 10, first floor, department of periodontology and oral implantology

Latur
MAHARASHTRA
431512
India 
Phone  9130009068  
Fax    
Email  ugalegauri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sawal Kala  
Designation  post graduate student  
Affiliation  Maharashtra institute of dental sciences and research dental college Latur 
Address  room no 10, first floor, department of periodontology and oral implantology

Latur
MAHARASHTRA
431512
India 
Phone  9422906216  
Fax    
Email  sawalkala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sawal Kala  
Designation  post graduate student  
Affiliation  Maharashtra institute of dental sciences and research dental college Latur 
Address  room no 10, first floor, department of periodontology and oral implantology

Latur
MAHARASHTRA
431512
India 
Phone  9422906216  
Fax    
Email  sawalkala@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra institute of dental sciences and research dental college, latur 
 
Primary Sponsor  
Name  Dr Sawal Kala 
Address  room no.10, first floor, department of Periodontology and oral Implantology, Maharashtra Institute of dental sciences dental college Latur, Maharashtra 431512 India  
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 Sawal Kala   Maharashtra institute of dental sciences and research dental college  room 10 department of periodontology and implantology Maharashtra institute of dental sciences and research dental college, Latur
Latur
MAHARASHTRA 
9422906216

sawalkala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee MIDSR DC Latur  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 
Intervention  Minimally invasive non-surgical therapy  Procedure will be performed under local anesthesia without adrenalin. Extensive debridement of the root surface down to the bottom of the periodontal pocket will be done. An effort will be made to reduce soft tissue damage using piezoelectric instruments with delicate, thin tips in conjunction with Gracey Mini curettes, which include after five /micro mini five (Hu Friedy). Gingival curettage and root planning will be strictly avoided. Loupes with a magnification of 3.5 × will be used to perform the procedure. After debridement, the intrabony defect will allow to naturally fill with blood in order to promote the establishment of a stable blood clot (subgingival rinses were avoided).  
Comparator Agent  Minimally invasive surgical therapy  Flap design - SPPF [simplified papilla preservation flap]41 when treating periodontal defects in narrow interdental spaces, typically less than 2mm wideor the MPPT [modified papilla preservation technique]42for more than 2mm wide space will be performed. The inter-dental incision extended to the buccal and lingual aspects of the two teeth adjacent to the defect. These incisions will be strictly intra-sulcular to preserve all the height and width of the gingiva. A very small full-thickness flap with the objective to expose just 1–2mm of the defect-associated residual bone crest will be elevated minimally. The suturing will be done with single modified internal mattress 6-0 silk suture at the defect associated inter-dental area to reach primary closure of the papilla without any tension. The procedure will be performed with use of 3.5 × loupes, microsurgical instruments and Incisions will be carried out using microsurgical blades. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient diagnosed with periodontitis stage 3.
2.Probing pocket depth more than or equal to 6mm with Radiographic intrabony defect depth more than or equal to 3mm at minimum 1 site.
3.Intrabony Defects not associated with furcation involvement.
4.Patient should have 20 teeth along with adjacent teeth to the defect site.
5.Patient with adequate width of attached gingiva.
 
 
ExclusionCriteria 
Details  1.Smokers (current or in past 5years), alcohol, drug abuse.
2.Medical history including diabetes, hepatic, renal disease, other serious medical conditions or transmittable diseases.
3.Patient on anti-inflammatory or anticoagulant therapy.
4.Systemic antibiotic therapy during the 3 months preceding the baseline exam
5.Pregnant or lactating women
6.Periodontal treatment at the study site within the last 12 months
7.Root canal treated tooth, prosthesis and class 2 restoration containing tooth at defect site and active orthodontic treatment.
8.Osseous lesion other than intrabony defect at defect site.

 
 
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 
clinical parameters (probing pocket depth and clinical attachment level), radiographic parameters (defect depth and defect width) in periodontal intrabony defects treated with minimally invasive non-surgical and minimally invasive surgical therapy.  Base line, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index, gingival index, and gingival marginal level in treatment of periodontal intrabony defects with minimally invasive non-surgical therapy and minimally invasive surgical therapy.
 
Base line, 3 months, 6 months  
pain perception in periodontitis patients with intrabony defects treated with minimally invasive non-surgical and minimally invasive surgical therapy  1st day and 7th day post surgery.  
correlation clinical and radiographic parameters in periodontal intrabony defects when treated with minimally invasive non-surgical and minimally invasive surgical therapy.  base line, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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 4 
Date of First Enrollment (India)   01/09/2025 
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)  Not Yet Recruiting 
Publication Details   N/A 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 [ugalegauri@gmail.com].

  6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-07-2027?
    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 is a chronic, multifactorial inflammatory disease caused by dysbiotic plaque biofilms. It leads to the progressive destruction of the supporting structures of teeth, including connective tissue and alveolar bone. Clinical signs of periodontitis include clinical attachment loss (CAL), radiographic bone loss, periodontal pocket formation, and gingival bleeding. In 2010, severe periodontitis was ranked as the sixth most prevalent disease globally, affecting about 11.2% of the population. As the disease progresses, it alters the morphology of the alveolar bone, leading to both horizontal and vertical bone defects. Vertical defects, also known as intrabony defects, are of particular concern due to their association with disease progression and increased risk of tooth loss. These defects form in an oblique pattern with the base of the defect located apically, forming a trough-like hollow adjacent to the root surface.

Intrabony defects pose a challenge in periodontal treatment due to limited accessibility.

While non-surgical interventions such as scaling and root planing can help in re-establishing the gingival contour, they often fail to resolve the underlying bone defects. This limitation can lead to persistent deep pockets and irregular bone healing, necessitating more advanced interventions. Traditionally, osseous surgical procedures have been employed to correct bony architecture. These include osteoplasty, which reshapes marginal bone, and ostectomy, which removes supporting bone. Although effective, these techniques often involve the sacrifice of tooth-supporting structures and result in gingival recession, which can be aesthetically unacceptable.

As a response to these drawbacks, periodontal therapy has evolved to adopt more conservative approaches. Instead of resective surgeries, clinicians have focused on regenerative techniques aimed at restoring lost bone and periodontal structures.

Periodontal regeneration often involves the use of bone grafts and barrier membranes. While effective, this approach can be costly, technique-sensitive, and sometimes unpredictable. To overcome these challenges, minimally invasive surgical techniques (MIST) were introduced. First described by Harrel and Rees, MIST emphasizes minimal flap reflection, reduced tissue trauma, and preservation of blood supply, thereby enhancing wound healing and reducing post-operative morbidity. Hunter and Sacker later refined the concept by introducing magnification tools such as surgical microscopes and loupes to perform delicate procedures in small areas. Building upon this concept, a minimally invasive non-surgical therapy (MINST) was introduced by Ribeiro et al. This technique maintains the principles of MIST but eliminates the need for surgical access. Ribeiro emphasized that true minimal invasiveness is not just defined by the use of magnification tools, but by the preservation of gingival architecture and careful handling of tissues. In their study, similar clinical attachment gains were reported for both surgical (2.8 mm) and non-surgical (2.6 mm) approaches, indicating comparable efficacy. Nibali et al. further developed a protocol for MINST that involves the use of micro-instruments for root debridement, magnification for precise visualization, and stabilization of the blood clot—all crucial for successful outcomes. A recent study by Jaimini Mehta et al. further supported the effectiveness of MINST, showing significant clinical improvements including reduced probing depth, gain in attachment levels, and radiographic bone fill. These findings indicate that MINST can serve not only as a pre-treatment strategy but also as a viable alternative to surgical methods.

Given the advantages of lower morbidity, reduced cost, and shorter treatment time, MINST presents an appealing approach. However, literature directly comparing MINST and MIST remains limited. Therefore, the present study aims to evaluate and compare the effectiveness of minimally invasive non-surgical therapy versus minimally invasive surgical therapy in the treatment of periodontal intrabony defects.

 
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