| CTRI Number |
CTRI/2025/07/091457 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Intracanal Medicament] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness Of Oxygen Gel As An Intracanal Medicament In Management Of Dentoalveolar Abscess Patients |
|
Scientific Title of Study
|
Effectiveness Of Oxygen Gel As An Intracanal Medicament In Management Of Dentoalveolar Dentoalveolar Abscess A Clinicomicrobial 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 |
Dr Ankita Vinayak Gadekar |
| Designation |
PG Student |
| Affiliation |
JMFs A.C.P.M Dental College |
| Address |
Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9403483403 |
| Fax |
|
| Email |
gadekarankita2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish Jadhav |
| Designation |
Reader |
| Affiliation |
JMFs A.C.P.M Dental College |
| Address |
Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9881248105 |
| Fax |
|
| Email |
drharishjadhav2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Vinayak Gadekar |
| Designation |
PG Student |
| Affiliation |
JMFs A.C.P.M Dental College |
| Address |
Department of Public Health Dentistry 3rd Floor Jawahar Medical Foundation Annasaheb Chudaman Patil Memorial Dental College Dhule
Dhule
MAHARASHTRA
424001
India |
| Phone |
9403483403 |
| Fax |
|
| Email |
gadekarankita2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| JMFs ACPM Dental College Dhule 424001 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Ankita Gadekar |
| Address |
JMFs ACPM Dental College Dhule 424001 Maharashtra India |
| 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 Ankita Gadekar |
JMFs ACPM DENTAL COLLEGE |
Department of Public Health Room No 8 Third Floor Dentistry JMFs ACPM Dental College Dhule
Dhule
MAHARASHTRA
Dhule
MAHARASHTRA |
9403483403
gadekarankita2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ANNASAHEB CHUDAMAN PATIL MEMORIAL DENTAL COLLEGE, INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K047||Periapical abscess without sinus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blue m Oral gel |
The blue®m oral gel has a low concentration of hydrogen peroxide, sodium perborate and glucose oxidase enzyme that promotes an increase in the levels of active oxygen and has been specially developed to accelerate the healing process in dentoalveolar abscess |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals suffering from dentoalveolar abscess
Individuals who were willing to participate in the present study and gave their written consent for the same
|
|
| ExclusionCriteria |
| Details |
Individuals suffering from any major systemic disease
Patient with any allergy or hypersensitivity to medicine
Pregnant females and nursing mothers were not considered to avoid any potential risks to them or their children.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oxygen gel significantly reduces anaerobic bacterial colony count in
dentoalveolar abscess patients and helps in the healing of periapical lesions by reducing
bacterial load. |
Baseline 7 days 14 days 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
antimicrobial efficacy of oxygen gel as
an adjunct in the endodontic management of dentoalveolar abscesses will help in patient
recovery & better prognosis of tooth. |
Baseline 7 days 14 days 21 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Background: Dental or dentoalveolar abscess is a denomination used to describe a localized collection of pus in the alveolar bone at the root apex of the tooth. The most commonly involved bacteria are both facultative anaerobic bacteria like in viridians streptococci anginosu and anerobic bacteria like Fusobacterium, Bacteroides fragilis , Prevotella intermedia and P. gingivalis , P. endodontalis species. The technology behind blue®m is centred on the controlled release of topical oxygen. The low, stable and safe concentration of hydrogen peroxide released also exhibits bactericidal action. Novelty: Innovative Use of Oxygen Gel as an intracanal medicament– While conventional therapies for dentoalveolar abscesses involve antibiotics and drainage, this study explores oxygen gel as a potential antimicrobial agent. Aims and Objectives: To access the effectiveness of oxygen gel in managing Dentoalveolar abscess and on anaerobic microorganisms in Dentoalveolar abscess. Methodology: Study will be conducted in Department of Public Health Dentistry and Department of Microbiology. Patients visiting the outpatient department of dental Institution with dentoalveolar abscess will be included in study. Access opening will be done and pus sample will be collected at baseline to check anaerobic bacteria Colony Forming Unit. Biomechanical preparation of canal will be done and oxygen gel will be given as an intracanal medicament. After 3 visits of patient again intracanal sample is taken and Colony forming unit will be checked for anaerobic bacteria. Expected Outcome: Oxygen gel significantly reduces anaerobic bacterial colony count in dentoalveolar abscess patients and helps in the healing of periapical lesions by reducing bacterial load. |