| CTRI Number |
CTRI/2025/09/094905 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to Compare Oxygen Gel Alone and with Laser Therapy in Treating Gum Diseases |
|
Scientific Title of Study
|
A comparative evaluation of oxygen releasing gel alone vs combined with low level laser therapy in the treatment of periodontitis a randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR S MEGHANA |
| Designation |
Postgraduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no 5, 2nd floor, Narayana dental college and hospital, Chinthareddypalem, Nellore, Andhra Pradesh, India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
6301447196 |
| Fax |
|
| Email |
smeghana833@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUKRUTHA B |
| Designation |
Reader |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no 5, 2nd floor, Narayana dental college and hospital, Chinthareddypalem, Nellore, Andhra Pradesh, India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9581440936 |
| Fax |
|
| Email |
drsukruthareddy9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUKRUTHA B |
| Designation |
Reader |
| Affiliation |
Narayana dental college and hospital |
| Address |
Room no 5, 2nd floor, Narayana dental college and hospital, Chinthareddypalem, Nellore, Andhra Pradesh, India.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9581440936 |
| Fax |
|
| Email |
drsukruthareddy9@gmail.com |
|
|
Source of Monetary or Material Support
|
| S Meghana Department of periodontology Narayana dental college and hospital Chinthareddypalem Nellore Andhra Pradesh India 524003 |
|
|
Primary Sponsor
|
| Name |
DR S MEGHANA |
| Address |
Room no.5, 2nd floor, Depaertment of periodontology, Narayana dental college and hospital, Chinthareddypalem, Nellore, Andhra pradesh, India - 524003 |
| 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 S MEGHANA |
Narayana dental college and hospital |
Room no 5, 2nd floor, Narayana dental college and hospital, Nellore.
Nellore
ANDHRA PRADESH |
6301447196
smeghana833@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC, NDCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K054||Periodontosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low level laser therapy |
pulsed mode of 980nm wavelength, frequency of 50hz, and power of 0.5 watt |
| Intervention |
Oxygen releasing gel |
Aqua, Alcohol, Glycerin, Silica, Sodium Saccharin, Sodium Perborate, Citric Acid, PEG-32, Sodium Gluconate, Lactoferrin, Xanthan Gum, Cellulose Gum |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
participants who are systemically healthy. Both sexes were included. Participants with age more than 30 years having periodontitis with periodontal pocket depths of more than 5mm after phase1 therapy. Participants who are cooperative and able to come for regular follow up. |
|
| ExclusionCriteria |
| Details |
Individuals with any known systemic condition. Usage of tobacco in any form. Individuals who underwent periodontal therapy in past 6 months. Pregnant or lactating women. Individuals with poor oral hygiene. Individuals who received antibiotic therapy, chemotherapeutic mouth rinses in past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in probing pocket depth, Clinical attachment level gain |
baseline, 3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in bleeding on probing |
baseline, 3 months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2026 |
| 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="1"
Months="0"
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
|
Participants with stage1, stage2 of grade A and B periodontitis will be selected from the outpatient Department of Periodontology, based on inclusion and exclusion criteria. Participants with probing pockets depth of more 5mm after phase 1 therapy will be selected. Seventy two participants will be selected and randomly assigned to 3 groups by computer generated randomization method. Probing pocket depth, clinical attachment level, bleeding on probing will be recorded at baseline and 3 months. In first group, selected site is subjected to low level laser therapy (wave length 980 nm, 50hz frequency and power 0.5watt). In the second group the selected site will be filled with oxygen releasing gel using a blunt end needle. In the third group, selected site is subjected to low level laser therapy (wave length 980 nm, 50hz frequency and power 0.5watt) along with oxygen releasing gel. |