| CTRI Number |
CTRI/2021/04/032564 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Deficient gum in between teeth by using Hyaluronic acid |
|
Scientific Title of Study
|
Management of Black Triangles by using 2% Hyaluronic acid |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satyaki Verma |
| Designation |
PG Student |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Room no 228 Dept of Periodontology and Implantology Institute of Dental Sciences
Bareilly
UTTAR PRADESH
243003
India |
| Phone |
9897517095 |
| Fax |
|
| Email |
satyakiverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hirak Bhattacharya |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Dept. of Peridontology and Implantology Institute of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243003
India |
| Phone |
|
| Fax |
|
| Email |
drhirakbhattacharya04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hirak Bhattacharya |
| Designation |
Professor |
| Affiliation |
Institute of Dental Sciences Bareilly |
| Address |
Dept. of Peridontology and Implantology Institute of Dental Sciences Bareilly
Bareilly
UTTAR PRADESH
243003
India |
| Phone |
9412451510 |
| Fax |
|
| Email |
drhirakbhattacharya04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Dental Sciences
Near suresh Sharma Nagar
Pilibhit Bypass road
Bareilly |
|
|
Primary Sponsor
|
| Name |
Satyaki Verma |
| Address |
Room no 123 Junior Faculty Quaters Rohilkhand Medical College |
| 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 Hirak Bhattacharya |
Institue of dental sciences, bareilly |
Room no 228, Dept. of Periodontology and Implantology
Bareilly
UTTAR PRADESH |
9412451510
drhirakbhattacharya04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients between the age groups of 18–55 years with papillary recession in the maxillary anterior teeth with intact contact point.
Plaque index less than 20%.
|
|
| ExclusionCriteria |
| Details |
Patients with caries, restoration, or crowns present in the adjacent teeth,
Patient with the habit of tobacco chewing, smoking, alcohol consumption, and
Patients with allergy/systemic disease/treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the clinic-radiographic effect of injection of HA gel for the reconstruction of deficient interdental papilla. |
Baseline, 7th day , 14th day, 21th day from intial infiltration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Hyaluronic Acid Gel in the non-surgical reconstruction of Interdental Papilla.
To evaluate the effect application of Hyaluronic Acid in the formation of new bone. |
Baseline, 7th day , 14th day, 21th day from initial infiltration |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2021 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyaluronic
acid was found to have extensive actions in various periodontal therapies such
as topically applied in subgingival regions reduces microbial activity, bone
regeneration in deep periodontal bony defects, guided bone regeneration,
nonsurgical treatment of peri-implantitis pockets, peri-implant maintenance of
immediately placed implants, and gingival augmentation in mucogingival surgery.
HA
is biocompatible and intrinsically safe to use, with no evidence of
cytotoxicity. HA gel, injections, or oral (by mouth) should not be used in
patients with allergies.
Therefore,
the aim of this randomised, parallel-grouped clinical trial is to assess the
effect of injection of HA gel for the reconstruction of deficient interdental papilla.
|