| CTRI Number |
CTRI/2025/08/093008 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [Oral Prophylaxis] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical and microbiological randomized trial to compare the effect of oral probiotics on bad breath in diabetic patients, with and without periodontitis |
|
Scientific Title of Study
|
A comparative study to evaluate and assess the efficacy of oral probiotics on oral halitosis in uncontrolled diabetics with and without periodontitis: a clinico- microbiological randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mac Fonseca |
| Designation |
Post Graduate Student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
40,Fonseca house,Luis de Menezes road Panaji Goa
Goa Dental College And Hospital, Department Number 2,
Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
North Goa
GOA
403001
India |
| Phone |
8975249860 |
| Fax |
|
| Email |
scorpian5mac@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mac Fonseca |
| Designation |
Post Graduate Student |
| Affiliation |
Goa Dental College and Hospital |
| Address |
40,Fonseca house,Luis de Menezes road Panaji Goa
Goa Dental College And Hospital, Department Number 2,
Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
North Goa
GOA
403001
India |
| Phone |
8975249860 |
| Fax |
|
| Email |
scorpian5mac@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr James Samuel |
| Designation |
Professor and Head of Department |
| Affiliation |
Goa Dental College and Hospital |
| Address |
Bambolim, Goa
North Goa
GOA
403202
Goa Dental College And Hospital, Department Number 2,
Department of Periodontics, Bambolim, Goa
North Goa
GOA
403202
North Goa
GOA
403202
India |
| Phone |
8975249860 |
| Fax |
|
| Email |
jamessamueldental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Dental College And Hospital, Bambolim, Goa North Goa GOA 403202 INDIA |
|
|
Primary Sponsor
|
| Name |
Mac Fonseca |
| Address |
Goa Dental College And Hospital, Department Number 2,
Department Of Periodontics, Bambolim, Goa India
403202 |
| 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 Mac Fonseca |
Goa Dental College And Hospital |
Department Number 2,
Department of
Periodontics,
Bambolim, Goa
North Goa
GOA
North Goa
GOA |
8975249860
scorpian5mac@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Dental College And Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: R196||Halitosis, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diabetic Patients(HbA1c 8%) who have Oral Halitosis with Periodontitis and treated with Oral Prophylaxis alone |
Blood investigations to evaluate the glycated haemoglobin.Subjective as well as Objective halitosis will be evaluated using the hand held portable Halimeter. Patients in this group will undergo oral prophylaxis at baseline and Plaque sample will be taken for microbiological evaluation of P gingivalis(Causative agent for Oral Halitosis).Periodontal parameters like Pocket probing depth (PPD) ), Clinical Attachment Level (CAL) Gingival index (Loe and Silness 1963), Plaque index (Silness and Loe 1964), Sulcus bleeding index (Muhlemann and Son, 1971) and Oral Health Related Quality of life Index(OhRQOL) will be recorded for each patient at baseline and after 3 months .HbA1c will be evaluated again after three months along with the microbiological sample of the plaque for P gingivalis |
| Intervention |
Diabetic Patients(HbA1c 8%) who have Oral Halitosis with Periodontitis and treated with Oral Prophylaxis and a chewable Oral Probiotic |
Blood investigations to evaluate the glycated haemoglobin.Subjective as well as Objective halitosis will be evaluated using the hand held portable Halimeter. Patients in this group will undergo oral prophylaxis at baseline and Plaque sample will be taken for microbiological evaluation of P gingivalis(Causative agent for Oral Halitosis).Periodontal parameters like Pocket probing depth (PPD) ), Clinical Attachment Level (CAL) Gingival index (Loe and Silness 1963), Plaque index (Silness and Loe 1964), Sulcus bleeding index (Muhlemann and Son, 1971) and Oral Health Related Quality of life Index(OhRQOL) will be recorded for each patient at baseline and after 3 months. Oral probiotic will be prescribed one tablet containing Streptococcus Thermophiles per day for one month and the HbA1c will be evaluated again after three months along with the microbiological sample of the plaque for P gingivalis |
| Comparator Agent |
Diabetic Patients(HbA1c 8%) who have Oral Halitosis without Periodontitis and treated with Oral Prophylaxis alone |
Blood investigations to evaluate the glycated haemoglobin.Subjective as well as Objective halitosis will be evaluated using the hand held portable Halimeter. Patients in this group will undergo oral prophylaxis at baseline and Plaque sample will be taken for microbiological evaluation of P gingivalis(Causative agent for Oral Halitosis).Periodontal parameters like Pocket probing depth (PPD) ), Clinical Attachment Level (CAL) Gingival index (Loe and Silness 1963), Plaque index (Silness and Loe 1964), Sulcus bleeding index (Muhlemann and Son, 1971) and Oral Health Related Quality of life Index(OhRQOL) will be recorded for each patient at baseline and after 3 months .HbA1c will be evaluated again after three months along with the microbiological sample of the plaque for P gingivalis |
| Intervention |
Diabetic Patients(HbA1c 8%) who have Oral Halitosis without Periodontitis and treated with Oral Prophylaxis and a chewable Oral probiotic |
Blood investigations to evaluate the glycated haemoglobin.Subjective as well as Objective halitosis will be evaluated using the hand held portable Halimeter. Patients in this group will undergo oral prophylaxis at baseline and Plaque sample will be taken for microbiological evaluation of P gingivalis(Causative agent for Oral Halitosis). Periodontal parameters like Pocket probing depth (PPD) ), Clinical Attachment Level (CAL) Gingival index (Loe and Silness 1963), Plaque index (Silness and Loe 1964), Sulcus bleeding index (Muhlemann and Son, 1971) and Oral Health Related Quality of life Index(OhRQOL) will be recorded for each patient at baseline and after 3 months . Oral probiotic will be prescribed one tablet containing Streptococcus Thermophiles per day for one month and the HbA1c will be evaluated again after three months along with the microbiological sample of the plaque for P gingivalis |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed diagnosis of type 2 Diabetes mellitus
Clinically perceptible halitosis
Atleast 20 teeth present
Localised or Generalised periodontitis in group |
|
| ExclusionCriteria |
| Details |
Patients taking any other medications
Patients with known allergies or hypersensitivity reactions
Pregnant and lactating women
Subjects who underwent periodontal treatment within a period of 6 months
H/O antibiotic intake at least 3 months prior
H/O use of mouthwashes within 4 weeks before the start of the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of Oral Halitosis |
Baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Microbiological assay(P gingivalis)
|
Baseline and 3 months |
| Reduction in HbA1c |
Baseline and 3 months |
| Reduction in Plaque index |
Baseline and 3 months |
| Reduction in gingival index |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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
|
The
study is a randomised controlled trial to evaluate the clinical effect of Oral
Probiotics as an adjunct to scaling and root planing(SRP) in the treatment
of Oral Halitosis in Diabetic patients with and without Periodontitis
The Objectives of the study are
1)To evaluate the
clinical effect of Oral Probiotic as an adjunct therapy to SRP on Oral
Halitosis in
a)Diabetic patients without Periodontitis
b)Diabetic patients with Periodontitis
2)To evaluate the clinical effect of SRP on microbiological parameters of
P. gingivalis in plaque samples at baseline and in six weeks 3)To evaluate the clinical effect of only SRP on Oral Halitosis in
a)Diabetic patients without Periodontitis
b)Diabetic patients with Periodontitis
IV. To evaluate the effect of the intervention on the Glycated haemoglobin
after 3 months
V.To compare the clinical parameters on test and control groups
|