| CTRI Number |
CTRI/2015/04/005689 [Registered on: 10/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
31/03/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Radiation Therapy
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of laser and surgical treatment on dark gums. |
|
Scientific Title of Study
|
To evaluate the efficacy of surgical stripping and diode laser techniques for gingival depigmentation. A clinical and histological study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Navjot kaur Chahal |
| Designation |
Post graduate student |
| Affiliation |
Surendera dental college and research institute, Sriganganagar, Rajasthan Pin code -335001 |
| Address |
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7726800764 |
| Fax |
0 |
| Email |
drnavjotchahal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Garg |
| Designation |
Guide |
| Affiliation |
Surendera dental college and research institute, Sriganganagar, Rajasthan Pin code -335001 |
| Address |
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
kamalgarg1064@rediffmail.com
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
9873546421 |
| Fax |
0 |
| Email |
kamalgarg1064@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Navjot kaur Chahal |
| Designation |
Post graduate student |
| Affiliation |
Surendera dental college and research institute, Sriganganagar, Rajasthan Pin code -335001 |
| Address |
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
Ganganagar
RAJASTHAN
335001
India |
| Phone |
7726800764 |
| Fax |
0 |
| Email |
drnavjotchahal@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self Investigator Initiated Trial |
| Address |
Department Of Periodontology and Oral Implantology
Surendera dental college and research institute Sriganganagar Rajasthan
|
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE |
H.H.Gardens Power House Road
Sriganganagar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Navjot kaur Chahal |
Department Of Periodontology & Oral Implantology |
Surendera dental college & research institute, Sriganganagar, Rajasthan Pin code -335001
Ganganagar
RAJASTHAN |
7726800764
0
drnavjotchahal@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 |
| Healthy Human Volunteers |
Gingival Hypermelanin pigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diode laser |
Diode laser at 940 nm wavelength utilized at 2 watt in continuous wave with brushing stroke method. |
| Intervention |
Surgical blade |
After local anesthesia one arch has been treated with surgical blade utilizing surgical stripping followed by removal of tissue tags. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having esthetic concern with bilateral physiologic gingival hyperpigmentation on the facial aspect, extending from distal aspect of right canine to the distal aspect of left canine of permanent dentition.
All the subjects should be available for minimum of 6 months.
|
|
| ExclusionCriteria |
| Details |
Smokers.
Pregnant and lactating mothers.
Debilitating systemic diseases.
Periodontal disease patients.
Patients with syndromes.
Patients using drugs related to hyperpigmentation.
Patients working in factories pertaining to metals could lead to hyperpigmentation etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Dummett oral pigmentation index (Clinical)
2.Hedin melanin index (Clinical)
3. Density of melanin granules
histopathologically |
Baseline(0day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Dummett oral pigmentation index (Clinical)
2.Hedin melanin index (Clinical)
3. Density of melanin granules
histopathologically
4. Visual analogue scale (intensity of pain )
5. Time duration to accomplish the procedure |
1. Dummett index (Clinical) post op at 3 and 6 month
2.Hedin index (Clinical) at 3 and 6 month post operative
3. Density of melanin granules
histopathologically at 6 month post operative
4. Visual analogue scale (intensity of pain ) at 1 and 7 days post surgical |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/02/2015 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Several treatment modalities have been suggested and presented in the literature for gingival depigmentation, such as slicing method, free gingival grafts, bur abrasion, cryosurgery or lasers etc. As the literature available so far is insufficient to precisely define the better method for depigmentation. According to the available literature, clinically surgical strippling is “gold standard†and others found lasers “the best†but the clinico histopathological evidence for the same is scarce. Therefore, the present study is designed with an aim to comparatively evaluate clinico histopathologically the effects of surgical stripping and diode laser technique for gingival depigmentation. |