| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ugalegauri@gmail.com].
- 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.
- 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. |