| CTRI Number |
CTRI/2026/03/105949 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of diode laser and light therapy in improving the treatment of gum and tooth diseases |
|
Scientific Title of Study
|
Efficacy of diode laser (980nm) and photobiomodulation (980nm) in nonsurgical periodontal therapy |
| 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 Munnam Vaishnavi |
| Designation |
post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Block2, Room no 7, Department of Periodontics, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
08978671135 |
| Fax |
08816250894 |
| Email |
munnamvaishnavi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Anil kumar |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block2, Room no 7, Department of Periodontics, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9677209549 |
| Fax |
08816250894 |
| Email |
anilkumar.perio@vdc.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr K Anil kumar |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block2, Room no 7, Department of Periodontics, Vishnupur, Bhimavaram
West Godavari ANDHRA PRADESH 534202 India |
| Phone |
9677209549 |
| Fax |
08816250894 |
| Email |
anilkumar.perio@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Munnam Vaishnavi |
| Address |
Block2,Room no 7,Department of Periodontics,Vishnupur,Bhimavaram,West Godavari |
| 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 Munnam Vaishnavi |
Vishnu Dental College |
Block2, Room no 7, Ground Floor, Department of Periodontics, Vishnupur, Bhimavaram-534202 West Godavari ANDHRA PRADESH |
08978671135 08816250894 munnamvaishnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, Vishnu Dental College |
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 |
Laser irradiation and Photobiomodulation |
Pocket will be irradiated with 980nm in a continuous mode(CW) of coronal and apical movement inside the periodontal pockets for 15 seconds with a power of 1W and photobiomodulation done with 980nm of wavelength,continuous wave mode,0.1 watt power,beam spot size 0.28cm2, duration of 30seconds at baseline, 1st,2nd, and 3rd weeks exposure from buccal surface in chronic periodontitis patients with probing pocket depth of 4-6 mm
|
| Intervention |
Photobiomodulation |
Laser beam of 980nm wavelength, will be focused in continuous wave mode with 0.1 watt power, beam spot size 0.28cm2 duration of 30seconds at baseline, 1st,2nd, and 3rd weeks exposure from buccal surface in chronic periodontitis patients with probing pocket depth of 4-6 mm |
| Comparator Agent |
scaling and root planing |
scaling and root planing will be done in chronic periodontitis patients with probing pocket depth of 4-6mm only once during the first appointment |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Generalized Periodontitis Stage II Grade B
2.Minimum pocket depth of (4-6 mm) will be included
|
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled systemic diseases
2.Pregnancy or lactating women
3.Patients under anticoagulant therapy
4.Chronic smoker.
5.Patients with infectious diseases ( HIV, Hepatitis)
6.Patients under antibiotic therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Inflammatory marker 1 beta
2.Probing pocket depth
3.Clinical attachment level
|
Baseline, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Plaque index
2.Bleeding on probing |
Assesed at baseline,3 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="0" 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
|
Patients reporting to the Department of Periodontics and Implantology Vishnu Dental College who are diagnosed with periodontal pocket depth of 4 to 6 mm will be recruited. Patients fulfilling the inclusion criteria will be selected. Informed consent will be taken. Patients will be divided into three groups. Clinical parameters such as plaque index, probing pocket depth, clinical attachment level and bleeding on probing will be assessed and gingival crevicular fluid collection will be done at baseline and at three months. Local anaesthesia will be administered at the site using two percent lignocaine. Scaling and root planing will be done for all three groups. In Test Group I photobiomodulation will be done from the buccal surface using a 980 nm diode laser for thirty seconds at baseline first second and third weeks. In Test Group II the pocket will first be irradiated with 980 nm diode laser in continuous mode with coronal and apical movement inside the periodontal pocket for fifteen seconds with a power of one watt followed by photobiomodulation from the buccal surface using a 980 nm diode laser for thirty seconds at baseline first second and third weeks. After the treatment the patient will be asked to return to the study center at three months for review of clinical parameters and gingival crevicular fluid collection for IL 1 beta. |