| CTRI Number |
CTRI/2025/09/095007 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study in participants with residual gum pockets comparing the intervention of scaling and root planing with and without oxygen gel to evaluate improvement in gum health. |
|
Scientific Title of Study
|
Comparative evaluation of scaling and root planing with and without oxygen-releasing gel in the treatment of residual periodontal pockets. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pothavarjula Satyasri |
| Designation |
post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of periodontics Room no-8 second floor
Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9491430741 |
| Fax |
|
| Email |
satyasripothavarjula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Kishore Kumar |
| Designation |
professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of periodontics Room no-8 second floor
Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9000534590 |
| Fax |
|
| Email |
kishoreuga@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pothavarjula Satyasri |
| Designation |
post graduate |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Department of periodontics Room no-8 second floor
Sibar Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9491430741 |
| Fax |
|
| Email |
satyasripothavarjula@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509 India |
|
|
Primary Sponsor
|
| Name |
Pothavarjula Satyasri |
| Address |
Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509 |
| 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 |
| Pothavarjula Satyasri |
Sibar Institute of Dental Sciences |
Sibar Institute of Dental Sciences Department of periodontics Room no-8 second floor Sibar Institute of Dental Sciences Takkellapadu Guntur 522509
Guntur
ANDHRA PRADESH |
9491430741
satyasripothavarjula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences |
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 |
Active oxygen-releasing gel (BlueM oral gel) |
Patients in group I will receive scaling and root planing (SRP) followed by the placement of active oxygen-releasing gel (BlueM oral gel), and patients will be followed up for 3 months for evaluating clinical parameters. |
| Comparator Agent |
without Active oxygen-releasing gel (BlueM oral gel) |
Patients in group II will receive scaling and root planing alone and patients will be followed up for 3 months for evaluating clinical parameters. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age 25 to 65 years
2. Not having received periodontal treatment for a minimum of 3 months prior to the study
3. Persistent periodontal pockets characterized by a PD 4-6 mm with positive BOP at baseline
4. Subjects willing to participate in the study
5. Radiographic evidence of horizontal bone loss 6. Subjects who are apparently healthy |
|
| ExclusionCriteria |
| Details |
1. Pregnant women and lactating mothers.
2. Radiographic evidence of vertical bone loss.
3. Subjects who have history of drug allergy.
4. Subjects who are under antibiotic therapy.
5. Any form of tobacco consumption
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical attachment level (CAL) with and without active oxygen releasing gel. |
To evaluate clinical attachment level (CAL) with and without active oxygen releasing gel at baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate Measurement of probing pocket depth (PPD),and Modified Sulcular Bleeding Index (msbi) with and without active oxygen releasing gel. |
To evaluate Measurement of probing pocket depth (PPD),and Modified Sulcular Bleeding Index (msbi) with and without active oxygen releasing gel at baseline and 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
31/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
At the initial visit, patients will be assessed for
eligibility based on inclusion and exclusion criteria. All the patients will
receive phase-1 therapy, consists of supra gingival scaling using ultrasonic
scaler and followed by oral hygiene instructions. All the patients will be
recalled after 14 days for measurement of baseline Clinical parameters,
including probing pocket depth (PPD), clinical attachment level (CAL), and
Modified Sulcular Bleeding Index (mSBI) will be recorded at baseline for both
groups. patients will be randomised into 2 groups. Patients in group I will
receive scaling and root planing (SRP) followed by the placement of active
oxygen-releasing gel (BlueM oral gel), while Group II will receive SRP alone.
Postoperative instructions will be given to all patients. Patients will be
recalled after 3months after the procedure for re-evaluation of the clinical
parameters |