| 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
|
|
|
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
|
|
|
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
|
|
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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)
|