| CTRI Number |
CTRI/2019/01/017269 [Registered on: 25/01/2019] Trial Registered Prospectively |
| Last Modified On: |
21/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare the effects of local application of hyaluronic acid gel and chlorhexidine gel in treatment of patients with gum disease. |
|
Scientific Title of Study
|
Comparative evaluation of the therapeutic effect of Hyaluronic acid gel (HA) with chlorhexidine gel used as a local drug delivery agent in patients with chronic periodontitis - A randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jaahnavi Lanka |
| Designation |
Post graduate student |
| Affiliation |
MCODS |
| Address |
Manipal College of Dental Sciences, MAHE, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
7036437357 |
| Fax |
|
| Email |
dr.jaahnavi.lanka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santhosh Kumar |
| Designation |
Associate Professor |
| Affiliation |
MAHE |
| Address |
Manipal College of Dental Sciences, MAHE, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
9741968550 |
| Fax |
|
| Email |
santhosh.kumar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jaahnavi Lanka |
| Designation |
Post graduate student |
| Affiliation |
MCODS |
| Address |
Manipal College of Dental Sciences, MAHE, Manipal, Karnataka.
Udupi
KARNATAKA
576104
India |
| Phone |
7036437357 |
| Fax |
|
| Email |
dr.jaahnavi.lanka@gmail.com |
|
|
Source of Monetary or Material Support
|
| SELF SPONSPORED
Dr.Jaahnavi Lanka
Post graduate student
Department of Periodontology
MCODS, Manipal,
Karnataka, 576104.
ph: 7036437357 |
|
|
Primary Sponsor
|
| Name |
Dr JAAHNAVI LANKA |
| Address |
DEPARTMENT OF PERIODONTOLOGY
MCODS
MAHE, Manipal.
MANIPAL 576104. |
| Type of Sponsor |
Other [SELF SPONSORED] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMA PAI PG THESIS GRANT |
MCODS MANIPAL MAHE 576104. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaahnavi Lanka |
Manipal College of Dental Sciences |
Department of Periodontology,
ROOM NO-3, DENTAL OPD BLOCK, Manipal College of Dental Sciences, MAHE, Manipal- 576104
Udupi
KARNATAKA |
7036437357
dr.jaahnavi.lanka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chlorhexidine gel |
It is a gold standard therapeutic agent used in periodontal therapy. In the present study 0.2% chlorhexidine gel will be used as local drug delivery agent in the pockets as a positive control.The frequency of application will be once after complete scaling and root planing. The therapy will last for 3 months. |
| Intervention |
Hyaluronic acid gel (0.2%, 0.8%, 1%) |
Hyaluronic acid is a naturally occurring high molecular weight non sulphated glycosaminoglycan which forms the major and critical component of connective tissue of human body. It is widely used in therapeutic procedures due to its high biocompatibility. It is named as a Safe drug by Beckar et al and is approved by the Food and Drug Association. In the present study 0.2 ml of 1%, 0.8%, 0.2% formulations of hyaluronic acid gel will be delivered in the pocket as local drug delivery agent in the test groups. The frequency of administration will be once after complete scaling and root planing. The therapy will last for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. patients with minimum of 18 natural teeth in mouth
2. chronic periodontitis patients with probing pocket depth
>/ 5mm in minimum of three teeth per quadrant bilaterally in the maxillary arch. |
|
| ExclusionCriteria |
| Details |
1.use of local or systemic antimicrobial agents 6 months prior to study. 2. previous periodontal therapy during last 6 months. 3.pregnancy 4. smokers 5.regular users of mouth wash. 6.chronic alcoholics 6.patients using vitamin supplements, anti inflammatory agents in past 3 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. clinical parameters between the different concentrations of hyaluronic acid gel are compared at 3 months. |
1. clinical parameters between the different concentrations of hyaluronic acid gel are compared at 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to evaluate drug release of hyaluronic acid gel released from gingival crevicular fluid after the treatment. |
4 hours, 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
23/02/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The remarkably high biocompatibility of hyaluronic acid gel is a pivot for its gain in popularity as a bio material scaffold in tissue engineering research and its use as a dermal filler in cosmetic procedures. in the field of dentistry the availability of hyaluronic acid in India commercially is rather less. Hyaluronic acid is highly biocompatible and no side effects are reported. Hence more research is needed for developing its use in Periodontal therapy in India.Therefore the aim of this study is to evaluate the different commercially available formulations of hyaluronic acid gel using it in Periodontal therapy. |