| CTRI Number |
CTRI/2024/06/068605 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of Blue M active oxygen gel and coe-pack dressing on depigmentation with scalpel |
|
Scientific Title of Study
|
Comparative evaluation of the effect of Blue M active oxygen gel and coe-pack dressing on postoperative surgical depigmentation healing-A Clinical Study |
| 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 Tusharika Sharma |
| Designation |
Postgraduate Student |
| Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
SUMANDEEP VIDYAPEETH CAMPUS KM SHAH DENTAL COLLEGE AND HOSPITAL ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY WAGHODIA VADODARA
SUMANDEEP VIDYAPEETH CAMPUS KM SHAH DENTAL COLLEGE AND HOSPITAL ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY WAGHODIA VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
8082864187 |
| Fax |
|
| Email |
tusharika4064@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Deshande |
| Designation |
PROFESSOR & PG GUIDE |
| Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Room no 7 Department of Periodontology Waghodia Vadodara
India
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Room no 7 Department Of Periodontology Waghodia Vadodara 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
7600918500 |
| Fax |
|
| Email |
drneerajd.kmsdch@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tusharika Sharma |
| Designation |
Postgraduate Student |
| Affiliation |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Room no 7 Department of Periodontology Waghodia Vadodara
India
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Room no 7 Department Of Periodontology Waghodia Vadodara 391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8082864187 |
| Fax |
|
| Email |
tusharika4064@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR TUSHARIKA SHARMA ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY KM SHAH DENTAL COLLEGE SUMANDEEP VIDYAPEETH VADODARA GUJARAT 391760 INDIA |
|
|
Primary Sponsor
|
| Name |
DR TUSHARIKA SHARMA |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Room no 7 Department of Periodontology Waghodia Vadodara 391760 Gujarat India |
| 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 TUSHARIKA SHARMA |
KM SHAH DENTAL COLLEGE AND HOSPITAL |
SUMANDEEP VIDYAPEETH CAMPUS KM SHAH DENTAL COLLEGE AND HOSPITAL ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY WAGHODIA VADODARA 391760 GUJARAT INDIA
Vadodara
GUJARAT |
8082864187
tusharika4064@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BlueM active oxygen gel |
Blue-M is controlled delivery of active oxygen i.e. hydrogen peroxide to the site of treatment. This occurs when Sodium perborate comes in contact with water, it creates a chemical process of hydrolysis, the end products being hydrogen peroxide and boric acid.
It will be applied by taking pea size on finger tip by the patient and to be applied thrice a day for one week . |
| Intervention |
Coe-Pak |
Coe-Pak is utilised as a benchmark when contrasting it with other dressings. Coe-Pak is a two-part dressing that doesnt include eugenol and also has bacteriostatic agents. Along with the general characteristics shared by
all periodontal dressings it doesnt include tissue stimulants like eugenol attaches effectively
to teeth and soft tissues and prevents the flap from separating from the root surface.It should be applied one tooth adjacent to the treatment done . |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
Patients with gingival hyperpigmentation
Patient with scoring criteria for Dummet Oral Pigmentation index more than 1 |
|
| ExclusionCriteria |
| Details |
Smokers
Pregnant and lactating women
Medically compromised patients
Those with a history of periodontal surgery in less than three months
Those with gingival pigmentation associated with other syndromes and lesions
Those with a score of more than one for plaque and gingivitis indices
Those with a score of less than three for DOP index |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dummett gupta oral pigmentation index |
baseline , 1week , 2 weeks , 3 weeks and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale, VAS (Steigmann 1965) |
after 2 hrs , after 24 hrs , 2 days , 3 days and 7 days |
| Re-epithelization index study Sridharan and Shankar, 2012 |
baseline , 1week , 2 weeks , 3 weeks and 1 month |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
16/06/2024 |
| 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="1"
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
|
Topical anesthesia was applied with 2% lidocaine, and the entire pigmented layer of gingival epithelium in addition to an underlying layer of connective tissue was removed by abrasion with a no. 15 surgical blade. The depigmentation procedure was performed from the mucogingival junction to the base of the interdental papilla. Direct pressure was applied with a sterile gauze to control hemorrhage during the surgical procedure .The depigmented area was covered with the conventional Coe-Pak periodontal dressing in the control group, whereas the Blue M active oxygen gel was applied to cover the depigmented area in the test group. Patient will be asked to apply Blue M active oxygen gel three times per day for one week at home. Patients will be recalled for follow up visit after 24 hours and 1 week postoperatively for the removal of Coe-pak dressing. |