| CTRI Number |
CTRI/2026/01/101745 [Registered on: 21/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Different Diode Laser Power Settings as an Adjunct to Scaling and Root Planing on Clinical Periodontal Parameters and Gingival Crevicular Fluid Levels in Patients with Chronic Periodontitis |
|
Scientific Title of Study
|
Comparative evaluation of 810 nm diode laser at various power settings as an adjunct to Scaling and Root Planing and Scaling and Root Planing alone on Gingival crevicular fluid levels of IL-1BETA and TNF-ALFHA in patients with chronic periodontitis: A split-mouth clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Hungund |
| Designation |
Post graduate student in Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster b, Bommanahalli, Near Hongasandra metro station, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
7019971357 |
| Fax |
|
| Email |
drpoojahungund@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. B. S. Jagadish Pai |
| Designation |
Head of Department of Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster b, Bommanahalli, Near Hongasandra metro station, Bengaluru
Bangalore
KARNATAKA
560068
India |
| Phone |
7019971357 |
| Fax |
|
| Email |
drpoojahungund@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Hungund |
| Designation |
Post graduate student in Periodontology |
| Affiliation |
The Oxford Dental College |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster b, Bommanahalli, Near Hongasandra metro station, Bengaluru
KARNATAKA
560068
India |
| Phone |
7019971357 |
| Fax |
|
| Email |
drpoojahungund@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pooja Hungund |
| Address |
The Oxford Dental College, NH-44, Hosur road, cluster b, Bommanahalli, Near Hongasandra metro station, Bengaluru |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pooja Hungund |
The oxford dental college |
Department of Periodontology, Room no 3, The Oxford Dental College, NH-44, Hosur road, cluster, near Hongasandra metro station
Bangalore
KARNATAKA |
7019971357
pooja.hungund2609@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with chronic generalised periodontitis and greater than or equal to 5mm pocket in each quadrant |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser with 0.8W |
In every patient full mouth SRP will be performed using hand instruments (Gracey curettes) and an ultrasonic device. The laser therapy using an 810 nm diode laser with the power output of 0.8W will be performed by inserting laser fibres into the pockets in such a way that they were in contact with the soft tissue wall of the pockets and parallel to the root surface and then they will be moved to the apical surface through a horizontal sweeping motion (1 mm/s) while remaining in contact with the soft tissue wall of the pockets. The application of the diode laser will be repeated at an interval of 1, 7 and 14 days respectively. |
| Intervention |
Laser with 1.5W |
In every patient full mouth SRP will be performed using hand instruments (Gracey curettes) and an ultrasonic device. The laser therapy using an 810 nm diode laser with the power output of 1.5W will be performed by inserting laser fibres into the pockets in such a way that they were in contact with the soft tissue wall of the pockets and parallel to the root surface and then they will be moved to the apical surface through a horizontal sweeping motion (1 mm/s) while remaining in contact with the soft tissue wall of the pockets. The application of the diode laser will be repeated at an interval of 1, 7 and 14 days respectively. |
| Intervention |
Laser with 1W |
In every patient full mouth SRP will be performed using hand instruments (Gracey curettes) and an ultrasonic device. The laser therapy using an 810 nm diode laser with the power output of 1W will be performed by inserting laser fibres into the pockets in such a way that they were in contact with the soft tissue wall of the pockets and parallel to the root surface and then they will be moved to the apical surface through a horizontal sweeping motion (1 mm/s) while remaining in contact with the soft tissue wall of the pockets. The application of the diode laser will be repeated at an interval of 1, 7 and 14 days respectively. |
| Comparator Agent |
Scaling and Root planing |
Scaling and Root Planing will be done using hand instruments (Gracey curettes) and an ultrasonic device. Oral Hygiene Instructions will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who agreed to participate in the study by signing the written informed consent.
2. Patients older than 18 years with chronic periodontitis
3. Deepest probing pocket depth of 4-6 mm in at anterior or posterior teeth at each of the quadrants of the jaw.
4. Patients with no history of any periodontal treatment for at least the last 3 months.
5. Subjects who have never smoked, or who have smoked less than 100 cigarettes in their lifetime. (Glossary Of Centers for Disease Control and Prevention).
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic disorders that could impact the outcome and prognosis of periodontal treatment, such as diabetes mellitus.
2. Patients who had taken antibiotics or anti-inflammatory drugs within the last three months.
3. Pregnant and lactating women.
4. Patients with periodontitis stage IV (Classification of periodontitis and peri-implant diseases and condition as proposed in 2017 World Workshop).
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical parameters which include gingival index, bleeding on probing, probing pocket depth, clinical attachment level will be measured on the first day (Day-0) and after 3 months. |
Clinical parameters which include gingival index, bleeding on probing, probing pocket depth, clinical attachment level will be measured on the first day (Day-0) and after 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/03/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
| Periodontal disease is a chronic inflammatory condition that results from the buildup of microbial plaque on the teeth and can lead to gingivitis, gingival recession, formation of periodontal pockets, vertical or horizontal alveolar bone resorption, and eventually, mobility and loss of the teeth. Although scaling and root planing is a popular non-surgical method for controlling inflammation, supplementing SRP with lasers has been hypothesized to help remove microbial plaque and reduce the number of periodontal pathogenic bacteria. Perpetuation of the host response by a persistent bacterial challenge disrupts homeostatic mechanisms and results in release of biologic mediators such as cytokines. These mediators of inflammation promote extra cellular matrix destruction in periodontium and stimulate bone resorption. Lasers have been extensively used in the treatment of periodontal disease. Among the lasers, the diode laser is one of the most popular laser technologies considering its low price, portability, and ease of use. The choice of the correct laser parameters is of great importance. Low energy settings may be ineffective in the complete removal of pocket epithelium, and high energy settings may cause thermal damage to the surrounding tissues. To our knowledge, studies suggesting the optimal range of power output and comparing the various power levels of diode laser as an adjuvant to SRP have not yet been conducted. In order to evaluate the efficiency of 810 nm diode laser as an adjuvant to scaling and root planing at various power settings 0.8W, 1W, and 1.5W, the current study also intends to evaluate the effect on GCF levels of IL-1BETA and TNF-ALPHA in Chronic Periodontitis patients. | |