| 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
|
|
|
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
|
|
|
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 89. Reference 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]2 /(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.
|