| CTRI Number |
CTRI/2025/11/097915 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of depigmentation using 980 nm diode LASER and Cryosurgery: A split mouth controlled trial. |
|
Scientific Title of Study
|
Comparison of depigmentation using 980 nm diode LASER and Cryosurgery: A split mouth 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 LEENA HARI |
| Designation |
PG Student |
| Affiliation |
Hazaribag college of dental sciences and hospital |
| Address |
Department of Periodontology
Room no 10
Hazaribag college of dental sciences and hospital
Demotand
Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
9097187995 |
| Fax |
|
| Email |
yathaarthshival@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shekhar Prashant |
| Designation |
HOD of department of periodontology Hazaribag college of dental sciences and hospital |
| Affiliation |
Hazaribag college of dental sciences and hospital |
| Address |
Department of Periodontology
Hazaribag college of dental sciences and hospital
Demotand
Hazaribag
JHARKHAND
825301
India |
| Phone |
9199223333 |
| Fax |
|
| Email |
yathaarthshival@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr LEENA HARI |
| Designation |
PG Student |
| Affiliation |
Hazaribag college of dental sciences and hospital |
| Address |
Department of Periodontology
room no 10
Hazaribag college of dental sciences and hospital
Demotand
Hazaribag
JHARKHAND
825301
India |
| Phone |
9097187995 |
| Fax |
|
| Email |
yathaarthshival@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hazaribag College of Dental Science and Hospital
Demotand
hazaribag 825301
Jharkhand
India |
|
|
Primary Sponsor
|
| Name |
Hazaribag College of Dental Science and Hospital |
| Address |
Department of Periodontology
Hazaribag college of dental sciences and hospital
demotand
hazaribag 825301
Jharkhand
India
Demotand
Hazaribag |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 LEENA HARI |
Hazaribag college of dental sciences and hospital |
Department of Periodontology
Room no 10
Hazaribag college of dental sciences and hospital
Demotand
Hazaribag 825301
Jharkhand
India
Hazaribag
JHARKHAND |
9097187995
yathaarthshival@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hazaribag college of dental sciences and hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects with good oral hygiene.
Moderate to heavy physiological gingival hyperpimentation (Dummett-Gupta,1964) |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cryosurgery |
gingival depigmentation will be done by using tetrafluoroethane as cryoagent in mandibular anterior segment |
| Comparator Agent |
diode LASER |
Gingival depigmentation will be done by using 980nm diode LASER in maxillary anterior segment |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 20-35yrs.
Both the genders will be considered.
Subjects with good oral hygiene.
Moderate to heavy physiological gingival hyperpigmentation (Dummett-Gupta,1964). |
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases associated with pathological hyperpigmentation.
Improper wound healing.
Allergic to local anaesthesia, antibiotics and analgesics.
Untreated periodontal disease.
Pregnant and lactating women.
Subjects who are already wearing prosthesis.
Non compliant patients.
Subjects with substance abuse. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| gingival pigmentation will be accessed using Dummett Gupta Oral Pigmentation Index in anterior region in both the arches. RGB red green blue values will also be accessed |
baseline and 3 months post operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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)
|
01/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study will be an observational , comparative, clinical trial which will be carried out on 34 sites of hyperpigmented anterior maxillary gingiva by split mouth technique, operated by a single examiner. Selection of patient’s site for depigmentation will be as followed- i)Site A- Maxillary anterior right sexant - using LASER ii)Site B- Maxillary anterior left sexant - using Cryosurgery All the subjects will be recalled after 24 hrs to evaluate any uneventful soft tissue changes. Clinical parameters like OHI-S, GI, PI and clinical photographs will be recorded at baseline and 1, 3 months postoperatively. Appearance of melanin pigmentation will be measured clinically at baseline and at 1 and 3 months post operatively and also analysed by photometric analysis using ImageJ software. All the other clinical parameters recorded at specific time interval will be subject for data analysis. Student t- test (unpaired/ independent t-test) where p is equal to or less than 0.05 denoted at level of clinical significance.
|