| CTRI Number |
CTRI/2024/04/066571 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
treatment of gum disease |
|
Scientific Title of Study
|
Evaluation of the clinical effectiveness of Erbium laser treated PRF in the management of gingival recession |
| 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 Shubhangini Chatterjee |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha Dental College Chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9536512825 |
| Fax |
|
| Email |
shubhanginichatterjee@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G. Kaarthikeyan |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College Chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9841222027 |
| Fax |
|
| Email |
kaarthikeyan@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangini Chatterjee |
| Designation |
Postgraduate resident |
| Affiliation |
Saveetha Dental College Chennai |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077
Chennai
TAMIL NADU
600077
India |
| Phone |
9536512825 |
| Fax |
|
| Email |
shubhanginichatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077 |
|
|
Primary Sponsor
|
| Name |
Dr Shubhangini Chatterjee |
| Address |
Clinic 25, 4th floor, Department of Periodontics, Saveetha Dental College,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077 |
| Type of Sponsor |
Other [Self (thesis project)] |
|
|
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 Shubhangini Chatterjee |
Saveetha dental college Chennai |
Clinic 25, 4th floor, Department of Periodontics,
No. 162, Poonamallee high road, Velapanchavadi, Chennai -600077
Chennai
TAMIL NADU |
9536512825
shubhanginichatterjee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical Committee (SDC-IHEC) |
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 |
CAF alone |
Caf alone for recession |
| Intervention |
Erbium laser treated PRF with CAF |
PRF prepared at 2700 rpm for 12 minutes is then treated with Erbium chromium YSGG laser |
| Intervention |
L-PRF with CAF |
Gingival recession coverage using prf |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Males and females aged 20 to 50 years with RT 1 or RT 2 gingival recession defects |
|
| ExclusionCriteria |
| Details |
Any patient who is not systemically healthy, and had undergone mucogingival surgery in the past |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recession height, mean recession coverage percentage, width of keratinised tissue |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing depth, clinical attachment loss, plaque index, gingival index |
Baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/05/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patients reporting to Periodontics dept, Saveetha Dental College will be recruited in the study, 15 in each of the three groups, all the patients with gingival recession of RT1 or RT2 type will be included and treated with coronally advanced flap (CAF) , CAF with L-PRF and CAF with Er-PRF respectively. These patients will undergo root coverage and records will be maintained for baseline and three month follow up. This trial is being undertaken to assess the effectiveness of Erbium laser treated PRF for management of gingival recession. |