FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062567 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 12/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of subgingival irrigation on gum diseases. 
Scientific Title of Study   Effectiveness of Subgingival Irrigation with Probiotic Solution on Periodontal Healing Outcome in Patients with Moderate-to-Severe Periodontitis as Compared Chlorhexidine Gluconate : A Randomized Controlled Clinical 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  Dr Sujeet Khiste 
Designation  Reader 
Affiliation  MGM Dental College And Hospital, Kamothe, Navi Mumbai. 
Address  Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India 
Phone  9833908511  
Fax  27423185  
Email  khistesujeet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujeet Khiste 
Designation  Reader 
Affiliation  MGM Dental College And Hospital, Kamothe, Navi Mumbai. 
Address  Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.

MAHARASHTRA
410209
India 
Phone  9833908511  
Fax  27423185  
Email  khistesujeet@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradnya Navnath Chaure 
Designation  PG Student 
Affiliation  MGM Dental College And Hospital, Kamothe, Navi Mumbai. 
Address  Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Department of Periodontics, Room no. 9, 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector 1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India 
Phone  7776977251  
Fax  27423185  
Email  pradnyachaure2014@gmail.com  
 
Source of Monetary or Material Support  
MGM Dental College and Hospital Kamothe Navi Mumbai 
 
Primary Sponsor  
Name  MGM Dental College and Hospital Kamothe Navi Mumbai 
Address  Department of Periodontics Room no. 9 7th Floor MGM Dental College and Hospital Junction of NH4 and Sion-Panvel Expressway Sector 1 Kamothe Navi Mumbai 
Type of Sponsor  Other [private dental college and hospital] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradnya Navnath Chaure   MGM Dental College and Hospital  Department of Periodontics floor no. 7 Room no. 9 Junction of NH4 and Sion-Panvel Expressway Sector 1 Kamothe Navi Mumbai Pin 410 209
Raigarh
MAHARASHTRA 
7776977251
27423185
pradnyachaure2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Mahatma Gandhi Missions Dental College and Hospital Kamothe Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Moderate-to-severe periodontitis 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K053||Chronic periodontitis, (3) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  SRP + Chlorhexidine gluconate 0.12% (ICPA Health Products Ltd.)  SRP + Chlorhexidine gluconate 0.12% (ICPA Health Products Ltd.) Single time Subgingival irrigation will be performed at baseline by using oral irrigation device (WaterPik). 
Intervention  SRP + Probiotic solution (Freshly prepared using Darolac sachets by Aristo Pharmaceuticals Pvt. Ltd.)  SRP + Probiotic solution (Freshly prepared using Darolac sachets by Aristo Pharmaceuticals Pvt. Ltd.) Single time Subgingival irrigation will be performed at baseline by using oral irrigation device (WaterPik). 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients belongs to age group from 25 to 65 years.
≥2 inter-proximal sites with clinical attachment level (CAL) ≥4 mm (not on the same tooth) or ≥2 inter proximal sites with PD ≥5 mm (not on the same tooth).
No history of having antibiotics during the last 6 months.
 
 
ExclusionCriteria 
Details  Patient with systemic disorders.
Pregnant and lactating women.
Patient with history of antibiotic use in last 6 months.
Patient allergic to chemicals going to used in this study.
Intrabony defects.
 
 
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 
Clinical attachment level and Probing depth
 
baseline, 4 weeks and 12 weeks from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index, Plaque index, Bleeding on probing  baseline, 4 weeks and 12 weeks from baseline 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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 
Date of First Enrollment (India)   01/03/2024 
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="6"
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  

This study design will be a prospective, Split mouth, randomized controlled trial in which the effectiveness of subgingival irrigation with probiotic solution on periodontal healing outcome in patients with moderate-to-severe periodontitis as compared to chlorhexidine gluconate at baseline, 4 weeks and 12 weeks from baseline.

Subjects satisfying the inclusion and exclusion criteria will be selected for the study. In this split mouth study design all the clinical parameters will be recorded at baseline. Once the scaling and root planing of the selected subject is done then the contralateral quadrants will be randomly assigned to 2 groups i.e. control group and test group.

Group I : SRP + Chlorhexidine gluconate 0.12% (ICPA Health Products Ltd.)

Group II : SRP + Probiotic solution (Freshly prepared using Darolac sachets by Aristo Pharmaceuticals Pvt. Ltd.)

Single time Subgingival irrigation will be performed at baseline by using oral irrigation device (WaterPik).

SAMPLE SIZE : 28 Sample size was determined using the estimates of mean and standard deviation values from literature [Jain R, Chaturvedi R, Pandit N, Grover V, Lyle DM, Jain A. Evaluation of the efficacy of subgingival irrigation in patients with moderate-to-severe chronic periodontitis otherwise indicated for periodontal flap surgeries. J Indian Soc Periodontol. 2020 Jul-Aug;24(4):348-353.] 

[Pandya DJ, Manohar B, Mathur LK, Shankarapillai R. Comparative evaluation of two subgingival irrigating solutions in the management of periodontal disease: A clinicomicrobial study. J Indian Soc Periodontol. 2016 Nov-Dec;20(6):597-602.] using the formula , Z1-α/2 is the z variate of alpha error i.e. a constant with value 1.96 

Z1-β i.e. a constant with value 0.84 (Reference for the formula: Chow S, Shao J, Wang H. 2008. Sample Size Calculations in Clinical Research. 2nd Ed. Chapman & Hall/CRC Biostatistics Series. page 89Reference for the values: https://www.jcpcarchives.org/full/sample-size-for-experimental-studies-53.php) Approximate estimates: 80% power, Type I error to be 5%, Type II error to be 20%, True difference of atleast 0.7 units between the groups, Pooled standard deviation of 0.941 , Substituting the values, n   =   2 (2.8)2  [0.941]/(0.7)2n = 28.3 Approximately 28 subjects / patients per group should complete the study at the endpoint follow up. For follow-up studies, to avoid loss by loss to follow up / attrition, kindly consider recruiting 5-25% more subjects so that even after attrition, we would be able to achieve the required minimum sample size. Also taking into consideration the attrition to be 10% , n= N / (1-0.10) ,n =   28.32  / (1-0.10) =   31.47 Approximately 32 subjects / patients per group need to be recruited in the present study.


 
Close