| CTRI Number |
CTRI/2024/11/077456 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effectiveness of combined hyaluronic acid mouthrinse with chlorhexidine and chlorhexidine mouthrinse alone on clinical parameters along with salivary aspartate marker level in Periodontitis patients after scaling and root planing |
|
Scientific Title of Study
|
Effectiveness of 0.1 percent Hyaluronic Acid with 0.2 percent Chlorhexidine Mouthrinse or 0.2 percent Chlorhexidine Mouthrinse alone as adjunct to scaling and root planing on clinical parameters and salivary aspartate aminotransferase marker in Periodontitis : A Prospective randomized observer blinded study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MGM/DCH/IEC/109/04/2024 |
Protocol Number |
| MUHS/Dental/MUHS-062314/2019 |
ClinicalTrials.gov |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saveen Mohod |
| Designation |
Post graduate (MDS) |
| Affiliation |
Mgm Dental College and Hospital Kamothe Navi Mumbai |
| Address |
Department of Periodontology, Room no.702 , 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector
1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8390393251 |
| Fax |
|
| Email |
mohodsaveen49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarika Shetty |
| Designation |
Professor and Guide |
| Affiliation |
Mgm Dental College and Hospital Navi Mumbai |
| Address |
Department of Periodontology, Room no.702 , 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector
1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
9820007410 |
| Fax |
|
| Email |
shettysarika98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saveen Mohod |
| Designation |
Post graduate (MDS) |
| Affiliation |
Mgm Dental College and Hospital Kamothe Navi Mumbai |
| Address |
Department of Periodontology, Room no.702 , 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector
1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA
410209
India |
| Phone |
8390393251 |
| Fax |
|
| Email |
mohodsaveen49@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM dental college and hospital kamothe Navi Mumbai 410206 |
|
|
Primary Sponsor
|
| Name |
Dr Saveen Mohod |
| Address |
MGM dental college and hospital kamothe Navi Mumbai 410206 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Reddys Laboratories Ltd |
Dr.No.7-1-27, Greenlands, Ameerpet Road, Leelanagar, Ameerpet Hyderabad, Telangana, 500016, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saveen Mohod |
Mgm Dental College and Hospital, Navi Mumbai |
Department of Periodontology, Room no.702 , 7th Floor, MGM Dental College and Hospital, at Junction of Sion Panvel Expressway, Sector
1, Kamothe, Navi Mumbai.
Raigarh
MAHARASHTRA
410209
India
Raigarh
MAHARASHTRA |
8390393251
mohodsaveen49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee (MGM DCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chlorhexidine Digluconate Mouthrinse |
Clohex ADS Mouthwash
13/C/UA/2010
10ml for 60 sec BD, For 2 months |
| Intervention |
Clohexidine with hyaluronic acid mouthrinse |
Clohex-Heal 26/1/Aushadhi/53/2019/19404
10ml for 60 sec BD, For 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects aged 18-60 years rendering informed consent.
2.Presence of minimum 20 natural scorable teeth excluding third molars.
3.Subiects diagnosed with Periodontitis based according to 2017 International Workshop for classification of Periodontal Diseases
and Conditions of the American Academy of Periodontology
4.Presence of at least 4 sites in different quadrants with a Probing depth of ≥5mm.
5.Subjects having good level of oral hygiene (a mean plaque index PI) score ≤ 1). |
|
| ExclusionCriteria |
| Details |
1.Subjects who have received any form of periodontal therapy, surgical or nonsurgical within past 6 months.
2.Subjects who have received antibiotic and/or anti-inflammatory therapy within the past 3 months.
3.Subjects wearing orthodontic appliances.
4.Subjects suffering from any systemic diseases like (Diabetes mellitus, cardiovascular diseases like ischemic heart disease, cerebrovascular diseases, and peripheral vascular disease,
osteoporosis, rheumatoid arthritis, respiratory diseases like COPD)
5.Subjects who give present or past history of drug abuse.
6.Subjects who give present or past history of smoking and tobacco consumption.
7.Pregnant women (Preterm/low birth weight babies) and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level and Probing pocket depth |
Baseline, 4 weeks and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Salivary aspartate aminotransferase marker |
Baseline, 4 weeks and 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="3"
Months="0"
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 Prospective, randomized, observer-blinded study will be conducted on patients with Periodontitis following scaling and root planing according to Bollen’s protocol of one stage full mouth disinfection comparing effectiveness of 0.1 % hyaluronic acid with 0.2% chlorhexidine mouthrinse or 0.2% chlorhexidine mouthrinse alone as adjunct to scaling and root planing on clinical parameters and salivary aspartate aminotransferase marker in Periodontitis.The primary objective of this study is to evaluate the clinical attachment level and probing depth (at baseline, 4 weeks and 8 weeks) and the plaque index (PI) and gingival index (at baseline, 4 weeks and 8 weeks) and the secondary objective is to evaluate the salivary aspartate aminotransferase levels (at baseline, 4 weeks and 8 weeks). |