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CTRI Number  CTRI/2025/08/093487 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can laser therapy help reduce and prevent the black stains on patients complaining of frequent recurrence when used along with cleaning  
Scientific Title of Study   Effectiveness of Low-Level Laser Therapy as an adjunct to Conventional Scaling and Polishing in treatment of Chromogenic stains and its recurrence 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 Sanjana V 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9964464502  
Fax    
Email  sanjanav8197@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M M Dayakar 
Designation  Head of the Department 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9448167427  
Fax    
Email  mmdayakar@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjana V 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327


KARNATAKA
574327
India 
Phone  9964464502  
Fax    
Email  sanjanav8197@gmail.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada India Pincode 574327 
 
Primary Sponsor  
Name  Dr Sanjana V 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
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 Sanjana V  KVG Dental College and Hospital  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 
9964464502

sanjanav8197@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K037||Posteruptive color changes of dental hard tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Diode LASER irradiation  Low level laser irradiation will be done prior to scaling and polishing using diode laser in biostimulation mode (0.5W, Continuous wave) for 30sec. 
Comparator Agent  Scaling and Polishing using Ultrasonic scaler  Conventional scaling and Polishing using Ultrasonic scalers will be performed followed by application of Topical fluoride gel. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Systemically and Periodntally healthy patients with age group between 18-50 years
2.Subjects with chief complaint of recurring chromogenic stains after multiple sessions of conventional scaling and polishing
3.Subjects with minimum 20 teeth present  
 
ExclusionCriteria 
Details  1.Pregnant and Lactating mothers
2.Smokers and Alcoholic patients
3.Patients with Kidney or Liver disease
4.Tooth with metallic restorations
5.Patient undergoing orthodontic therapy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare and evaluate the effectiveness of Low-Level Laser Therapy in combination with Scaling and Polishing versus Scaling and Polishing alone in managing Chromogenic Bacterial Stains and preventing its recurrence.  1. At Baseline
2. At 2 Weeks
3. At 2 Months
4. At 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of scaling and polishing only, in patients with black stains
2. To evaluate the efficacy of low level laser therapy as an adjunct to scaling and polishing
3. To monitor the number of days of recurrence of black stains after scaling and polishing alone
4. To monitor the number of days of recurrence of black stains after LLLT as an adjunct to scaling and polishing
5. To compare and evaluate both the procedures with respect to the recurrence of the black stains
 
1. At Baseline
2. At 2 Weeks
3. At 2 Months
4. At 6 Months 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 3 
Date of First Enrollment (India)   08/12/2025 
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 - NO
Brief Summary  

Tooth discoloration is a common dental concern with clinical and aesthetic implications. It is classified as extrinsic, intrinsic, or internalized. Extrinsic discoloration occurs on the tooth surface or pellicle due to deposition of colored compounds or chemical reactions. Intrinsic stains arise when pigmented substances incorporate into the tooth structure during development. Internalized discoloration refers to extrinsic stains penetrating into the tooth substance after development.

Black stain (BS), also termed chromogenic stain, is an extrinsic discoloration characterized by pigmented dark lines or dots along the gingival margin, usually limited to the cervical third of the crown. Its prevalence ranges from 1% to 20%, peaking in childhood. Despite professional care, recurrence remains a challenge. The exact etiology is unclear, but evidence suggests involvement of chromogenic microorganisms, diet, and oral hygiene. Black-pigmented anaerobes such as Porphyromonas gingivalis, Prevotella intermedia, P. melaninogenica, and P. nigrescens contribute to pigment formation. Actinomyces species have also been implicated. These organisms produce ferric sulfides through a reaction of hydrogen sulfide (from bacterial metabolism) with salivary iron. The resulting black pigment is mainly iron protoporphyrin derivatives.

Laser therapy offers a promising alternative to conventional treatments like polishing, microabrasion, bleaching, and whitening pastes. Lasers generate coherent, collimated light with tissue interactions depending on wavelength. In periodontology, lasers are used for calculus removal, soft tissue incision, decontamination, biostimulation, bacterial reduction, and osseous surgery. For example, Er:YAG and Er,Cr:YSGG are effective for hard tissues, while diode and Nd:YAG lasers target pigmented tissues and hemoglobin, making them suitable for coagulation and pigmentation removal.

Low-Level Laser Therapy (LLLT), or photobiomodulation, utilizes low-power red (600–700 nm) or infrared (770–1200 nm) light for non-thermal, photochemical effects. It enhances healing, reduces inflammation and pain, and stimulates cellular metabolism by activating mitochondrial cytochrome c oxidase. LLLT avoids tissue overheating and works through mechanisms similar to lethal laser photosensitization.

For BS management, LLLT targets bacterial chromophores such as protohaem and protoporphyrin, which absorb red light and generate a lethal effect on pigmented bacteria without additional dyes. This approach may improve stain removal and reduce recurrence compared to conventional therapies, offering a minimally invasive, biologically based treatment modality.

 
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