| 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
|
|
|
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
|
|
|
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. |