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CTRI Number  CTRI/2025/05/087900 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparing the gum status of diabetes patients with or without laser treatment 
Scientific Title of Study   Comparative evaluation of periodontal status of periodontits with type-2 diabetes mellitus patients after scaling and root planing with or without photobiomodulation - A split-mouth randomised 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  Gayatri Tripathy 
Designation  Postgraduate student 
Affiliation  SCB Dental College and Hospital 
Address  Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack-753007
Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack-753007
Cuttack
ORISSA
753007
India 
Phone  9438590404  
Fax    
Email  gayatritripathy25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Subash Chandra Raj 
Designation  Professor and Head 
Affiliation  SCB Dental College and Hospital 
Address  Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack-753007

Cuttack
ORISSA
753007
India 
Phone  9437008298  
Fax    
Email  drsubash007@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Gayatri Tripathy 
Designation  Postgraduate student 
Affiliation  SCB Dental College and Hospital 
Address  Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack-753007
Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack-753007
Cuttack
ORISSA
753007
India 
Phone  9438590404  
Fax    
Email  gayatritripathy25@gmail.com  
 
Source of Monetary or Material Support  
SCB Dental College and Hospital, Cuttack, Odisha, India, Pincode-753007 
 
Primary Sponsor  
Name  Gayatri Tripathy 
Address  Department of Periodontics and Oral Implantology, SCB Dental College and Hospital, Cuttack, Odisha, India, Pincode-753007 
Type of Sponsor  Government medical 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 Gayatri Tripathy  SCB Dental College and Hosspital  3rd Floor, Department of Periodontics and Oral Implantology
Cuttack
ORISSA 
9438590404

gayatritripathy25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC), SCB Dental College and Hospital, Cuttack, Odisha  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  SCALING AND ROOT PLANING   In all participants a full mouth supragingival SRP will be performed using a piezoelectric ultrasonic unit (NSK Scaler (OEM) Unit) and hand scalers until a smooth tooth surface is obtained. A full mouth subgingival instrumentation will be carried out under local anaesthesia using Gracey, Hu-Friedy curettes. The treatment will be continued until the root surfaces are adequately debrided and planed. 
Intervention  SCALING AND ROOT PLANING WITH PHOTOBIOMODULATION  In this study, data collection will be carried out through proper history taking of the participants in Phase 1, while in Phase 2, a detailed clinical examination and evaluation of all pertinent clinical parameters will be performed. Phase 3 will involve the validation of these findings through relevant investigations, including haematological and radiological assessments. After the screening procedure in Phase 4, patients will be selected in accordance with the inclusion criteria, and the examiner will demonstrate oral hygiene instructions. For Phase 5, the final selection for the study will be determined based on subjects compliance, and an acrylic template will be fabricated on the study model, encompassing at least one tooth anterior and posterior to the chosen teeth sites to serve as a fixed reference guide for measurements. Finally, Phase 6 will see the application of PBMT in the test sites described below, in addition to conventional scaling and root planing in the control sites. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patient (Type 2 DM).
2.Pocket depths greater than or equal to 5mm measured with UNC 15 probe.
3.Clinical attachment loss greater than or equal to 4mm measured with UNC 15 probe.
4.Patients with Type 2 Diabetes Mellitus classified based on criteria of American Diabetic Association (ADA) and glycated haemoglobin levels (HbA1C) and not having systemic complications of diabetes.
5.No history of periodontal therapy in the preceding 1 year.
6.No use of antibiotics or long-term anti-inflammatory drugs in the preceding 6months
 
 
ExclusionCriteria 
Details  1.With known systemic disease (other than type 2 diabetes)
2.Individuals with localised infection other than periodontitis.
3.Use of tobacco in any form and alcohol
4.Immunocompromised individuals
5.Pregnant or lactating females
6.Tooth with hopeless prognosis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in Probing pocket depth, Relative Clinical attachment level, change in gingival index, Plaque index and glycaemic health status   Baseline, 1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
IL-1β levels in GCF   Baseline to 6 months  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/06/2025 
Date of Study Completion (India) 10/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Periodontitis is a multifactorial disease, in which a complex microbial ecology that matures in biofilms in the subgingival sulcus triggers a chronic immunoinflammatory lesion that leads to loss of clinical attachment due to the destruction of the periodontal ligament and adjacent supporting bone. 

 

Diabetes mellitus is a chronic metabolic disease characterized by hyperglycaemia. It results from insulin resistance, insulin deficiency, or a total lack of insulin. It has four subgroups: type 1 DM (insulin-dependent diabetes), type 2 DM (non-insulin-dependent diabetes), gestational DM, and other specific types. Among DM patients, 90–95% have type 2 diabetes. DM and periodontal disease have a bidirectional relationship. DM can increase the prevalence, incidence, and severity of periodontal diseases. Likewise, periodontal diseases can complicate the metabolic control of DM. 

 

Inhibiting progression of inflammation by mechanical debridement of plaque and calculus harbouring the disease progression is the mainstay of management of periodontitis. The purpose of scaling and root planning (SRP) is to remove such local irritants from the teeth surface and to minimize tooth surface roughness which may facilitate the accumulation of local irritants around the teeth. Mechanical therapy alone may not always be predictable or fully eliminate periodontal infection and inflammation. It can fail to remove pathogenic bacteria located deep within the periodontal tissues or in inaccessible areas. This is especially true for systemically compromised patients and individuals with severe periodontitis, such as diabetic patients. 

 

Adjunctive periodontal therapies, such as the use of antimicrobial agents, antimicrobial photodynamic therapy, and lasers of various wavelengths, are often recommended to enhance the outcomes of mechanical treatment. These additional therapies have shown positive clinical impact in the management of periodontitis. The use of laser applications has been raised as an alternative to supportive treatments to increase the efficacy of nonsurgical periodontal treatments and decrease the limitations. 

 

 

Researches related to photo biomodulation therapy (PBMT) are conducted at the level of in vitro or animal studies. Photo biomodulation (PBM), formerly known as low-level laser therapy (LLLT), is a therapeutic treatment that uses optimal doses of laser photonic energy in the red and near infrared wavelengths. These wavelengths are part of the electromagnetic spectrum’s "optical therapeutic window." Evidence has proven that PBM therapy (PBMT) stimulates gingival fibroblast proliferation and improves its organization. 

 

Administration of PBMT has a positive effect on cell proliferation in gingival fibroblasts, resulting in increased expression of FGF-b. In another study by Hakkı et al., laser photo biomodulation was found to significantly increase the expression of type-1 collagen mRNA. PBMT has drawn significant attention for its biostimulative effect on tissue healing. Cellular and animal studies have reported that it increases fibroblast and osteoblast activation, contributing to tissue healing. This effect is noteworthy not only in healthy individuals but also in patients with systemic diseases such as DM.When used as an adjunct to periodontal therapy, PBMT may potentiate the effects of SRP by reducing bacterial load, altering inflammatory response and accelerating healing. However, in patients with uncontrolled type 2 DM, where periodontal disease progresses more severely, there are limited studies on the additional benefits of PBMT. 

 

 

Considering the above facts, the aim of the current study is to investigate and evaluate the periodontal status of type-II diabetes mellitus patients with periodontitis after scaling and root planning with and without PBMT (photo biomodulation therapy)

 

 
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