| CTRI Number |
CTRI/2024/08/072066 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
can you use probiotics instead for antibiotics for treating gum infections |
|
Scientific Title of Study
|
Exploring the role of probiotics for the management of periodontal abscess |
| 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 Mohini Gautam |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Science ,Manipal |
| Address |
Department of Periodontology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Madhav Nagar, Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
6203645930 |
| Fax |
|
| Email |
mohini.mcodsmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Aditi Chopra |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental Science, Manipal, Manipal Academy of Higher Education |
| Address |
Department of Periodontology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Madhav Nagar, Udupi district, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
draditichopra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohini Gautam |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental Science ,Manipal |
| Address |
Department of Periodontology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Madhav Nagar, Udupi district
Udupi
KARNATAKA
576104
India |
| Phone |
6203645930 |
| Fax |
|
| Email |
mohini.mcodsmpl2023@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr. Mohini Gautam,Post Graduate Student,Department of Periodontology,Manipal College of Dental Science,Manipal Academy of Higher Education , Madhav Nagar, Udupi District, Karnataka, India,576104 |
|
|
Primary Sponsor
|
| Name |
Dr Mohini Gautam |
| Address |
Department of Periodontology , Manipal College of Dental Sciences , Manipal , Manipal Academy of Higher Education , Madhav Nagar , Udupi District , 576104 |
| 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 Mohini Gautam |
Manipal College of Dental Science, Manipal |
Department of Periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Madhav Nagar, Udupi District
Udupi
KARNATAKA |
6203645930
mohini.mcodsmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antibiotics |
Tablet Amoxicillin 500 mg and Tablet Metronidazole 400 mg
combination) given orally for 7 days |
| Intervention |
Probitics (velbiom) |
200 CFU
Twice Daily Orally for 15 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a) Both male and female participants aged between 18 to 75 years
with and without a history of diabetes will be included;
b) Participants diagnosed with
swelling in periodontium which is diagnosed as a periodontal abscess with a pre-
existing periodontal pocket) as defined by the 2017 classification;
c) Participants
having more than 3 mm probing depth and interdental bone loss as diagnosed with
the radiograph or clinical attachment loss of more than 1 mm with bleeding on probing
present.
d) Patients with a minimum of 10 functional teeth. |
|
| ExclusionCriteria |
| Details |
a) Participants with a history of any systemic disease/conditions
other than diabetes;
b) Participants with a history of any drug intake/medication for
any systemic disease other than diabetes mellitus; c) Participants reporting any allergy
to amoxicillin and metronidazole
d) Current and former smokers and those consuming
alcohol;
e) Participants with any form of oral abusive habit such as gutka, pan, supari,
areca nut,etc.;
f) Participants undergoing any radiation or chemotherapy;
g) Pregnant
and lactating women ;
h) Participants who have undergone any periodontal therapy in
the previous month ;
i) Participants who were under any antibiotics in the previous three months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in microbial profile, colony forming unit, and CRP levels
before and after the intervention |
At Baseline and 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the changes in the microbial profile in subgingival biofilm
and serum of patients with periodontal abscesses before and after the probiotics and
antibiotics treatment.
To evaluate the change in the C-reactive proteins (CRP) in the serum of patients
with periodontal abscess before and after taking probiotics compared to antibiotics |
Baseline , 7 day , 15 day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
08/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/04/2026 |
|
Estimated Duration of Trial
|
Years="26"
Months="7"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response (Others) - Anyone who request via email through ethics committee approval
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [aditi.chopra@manipal.edu].
- For how long will this data be available start date provided 22-07-2026 and end date provided 22-07-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
According to the classification by the American Academy of Periodontology , a periodontal abscess is defined as “a localized purulent infection with collection of pus in the periodontal tissues. It is a common clinical feature in patients with moderate or advanced periodontitis†. According to the 2017 classification of periodontal disease, periodontal abscess is classified into two categories: periodontal abscess in periodontitis patients (in pre-existing periodontal pocket) and periodontal abscess in periodontitis patients (not mandatory to have pre-existing periodontal pocket) . Periodontal abscess is usually managed after localized removal of pus from the gums with or without the need for root canal treatment depending upon the vitality of the pulp . The periodontal abscess is managed by draining the abscess by making a small pinpoint opening at the site of the abscess or curettage using a curette via the existing periodontal pocket. After drainage of the pus, local irrigation of the abscess with betadine or chlorhexidine is done and the patient is prescribed antibiotics for 5-7 days. The most common antibiotics used for treating periodontal abscesses are tetracycline, amoxicillin, or metronidazole . However, recent evidence has proven that oral microflora has become resistant to these conventional antibiotics . Herrera et al. 2023 found that antibiotics like metronidazole, tetracycline, doxycycline, and minocycline are no longer effective in the management of periodontal and periapical diseases . Abe et al 2022 also noted that many oral pathogens commonly seen in periodontal abscesses, such as Prevotella and Porphyromonas species, have been shown to become resistant to conventional antibiotic therapy. Amoxicillin and ampicillin (39.5%) were found to have the highest frequency of resistance and ciprofloxacin was shown to have the lowest frequency of resistance (3.4%). This rapid increase in antibiotics is often attributed to the massive use and misuse of antibiotics for the treatment of periodontal disease, including periodontal abscesses. Recent guidelines by the American Dental Association (ADA) questioned the use of antibiotics for the management of periodontal abscesses and recommended viable alternatives to antibiotics should be researched. A recent systematic review by Leroy et al 2022 also concluded that with the development of antimicrobial resistance, the need for alternatives to antibiotics needs to be explored . Antibiotics should not be randomly given to all patients, unless there is a specific need and systemic involvement (for example, malaise or fever) is present . Recently a study by Irshad et al.,2020 also found that dentists prescribe antibiotics to all patients with abscess which results in the development of antimicrobial resistance . With the marked rise in antibiotic resistance, many studies have explored the role of various alternatives such as probiotics to manage infectious diseases like periodontal abscess. Probiotics are “living microorganisms, mainly bacteria when taken in proper quantities may provide beneficial effects for human health . Studies have shown that probiotics can be used for the management of infectious diseases such as abscesses of the breast , respiratory tract infections , and patients with ventilator pneumonia . A recent systematic review by Lakshmi et al (2023) also explored the role of probiotics compared to antibiotics for the management of periodontal disease and found that probiotics can be used as viable alternatives to antibiotics for the management of periodontal diseases . Since probiotics release important antimicrobial compounds that have been shown to have promising antimicrobial and immune-modulating properties, their role in microbial infections such as periodontal abscesses, especially in the era of antibiotic resistance is important . With this background, the present research aims to explore the efficacy of probiotics compared to antibiotics for the management of periodontal abscesses |