| CTRI Number |
CTRI/2025/03/082148 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of herbal dressing with COE PAK after gingival depigmentation procedure |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of herbal dressing containing vitamin C and banana peel extract with COE PAK after gingival depigmentation procedure: a Ramdomised controlled trial |
| 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. Roshni Valecha |
| Designation |
postgraduate student |
| Affiliation |
Ranjeet Deshmukh Dental College, Nagpur |
| Address |
104, department of periodontics Ranjeet Deshmukh Dental College and research centre nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
09518737548 |
| Fax |
|
| Email |
drroshnivalecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
professor |
| Affiliation |
Ranjeet Deshmukh Dental College, Nagpur |
| Address |
104, Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SUREKHA RATHOD |
| Designation |
professor |
| Affiliation |
Ranjeet Deshmukh Dental College, Nagpur |
| Address |
104, Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9011071477 |
| Fax |
|
| Email |
drsurekhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| self, Ranjeet Deshmukh Dental College and Research Centre , India 440019 |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre , Pincode 440019 |
| 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 Surekha Rathod |
Ranjeet Deshmukh Dental College and Research Centre |
room no. 103,
Department of Periodontics, Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA |
09011071477
drsurekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingival hyperpigmentaton |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COE PAK |
Periodontal Dressing
duration 7 days
frequency once after surgery
|
| Intervention |
periodontal dressing after gingival depigmentation |
periodontal dressing containing vitamin c and banana peel extract
duration 7 days
frequency once after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
. Systemically healthy participants with gingival melanin hyperpigmentation.
2. Moderate to heavy melanin pigmentation in patient in the anterior gingiva from canine to canine (esthetic zone) according to Dummett oral pigmentation index
|
|
| ExclusionCriteria |
| Details |
Participants with any systemic diseases, especially those having healing problems, such as uncontrolled diabetes and auto-immune disease
2.Tobacco smokers
3.Pregnant women
4.Pathological gingival hyperpigmentation, including Addison’s disease, neurofibromatosis, oral melanotic maculae, oral mucosal melanoma, and drug-induced oral mucosal pigmentation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Dummett Oral Pigmentation Index (DOPI) is used to measure the intensity of gingival pigmentation
2. Dermascopic examination of melanocyte patterns
|
BASELINE AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS scale is used to measure pain intensity or other subjective characteristics
Landry’s Healing Index is used to assess the progress of wound healing
|
BASELINE AND 6 MONTHS |
|
|
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 2 |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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="1"
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
|
The
study will comprise of 25 patients (50 sites) visiting the Department of Periodontology
and Implantology, exhibiting
gingival hyperpigmentation. Sides will be assigned randomly for each of the
treatment groups.
The
study will be conducted in Department of Periodontology and Implantology, after
taking informed consent from the patient. All the clinical parameters will be
evaluated at baseline after which the sites
in the patients will be randomly divided into Group I and Group II.
Prior
to the study, study protocol will be explained to the patients and a written
informed consent will be obtained.
The
study will be initiated after the clearance from the Institutional Ethics
Committee.
Surgical Procedure:
Preoperative
intraoral therapy and assessment of complete medical, family history, and blood
investigations will be carried out to exclude any surgical contraindication and
confirm the diagnosis of gingival pigmentation. Under local anesthesia gingival
depigmentation will be carried out in the maxillary or mandibular aesthetic
areas, from the canine/1st premolar region to contralateral similar tooth
region, with scalpel procedure.
Clinical
photographs, DOPI index, and Dermascopic examination will be taken for gingival pigmentation at baseline
and 6 months.
|