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CTRI Number  CTRI/2024/08/072090 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Evaluation of LASER therapy for gum depigmentation utilizing injectible platelet rich fibrin 
Scientific Title of Study   Clinical Evaluation of Gingival Wound Healing, Post-operative Satisfaction and Recurrence of Pigmentation with or without Injectable Platelet-Rich Fibrin in the Treatment of Gingival Hyperpigmentation using Diode LASER - A Split Mouth 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 S Vidya Sagar 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Room No 6 Department of Periodontics Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  09989117747  
Fax  08682272296  
Email  drsagarperio@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N BUELA GRACE 
Designation  Post graduate student 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Room No 6 Department of Periodontics Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  9640669171  
Fax  08682272296  
Email  buelagrace996@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr S Vidya Sagar 
Designation  Professor 
Affiliation  Kamineni Institute of Dental Sciences 
Address  Room No 6 Department of Periodontics Narketpally

Nalgonda
TELANGANA
508254
India 
Phone  09989117747  
Fax  08682272296  
Email  drsagarperio@gmail.com  
 
Source of Monetary or Material Support  
nill 
 
Primary Sponsor  
Name  Kamineni Institute of Dental Sciences 
Address  Sreepuram Narketpally District Nalgonda Telangana 508254 India 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Vidya Sagar  Kamineni Institute of Dental Sciences  Department of Periodontics Room number 6 First floor Narketpally
Nalgonda
TELANGANA 
09989117747

drsagarperio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kamineni Institute of Dental Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  injectable Platelet Rich Fibrin (i-PRF)  Group I: In all the patients, the gingiva of 1st quadrant will be deposited once with 1ml of i-PRF intramucosally for 1min after depigmentation procedure using diode laser at 980nm for 20mins.  
Comparator Agent  LASER  GroupII In all the patients depigmentation procedure using diode laser at 980nm will be done in the gingiva of 2nd quadrant for 20mins  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Ages: 16 to 45 years old
Systemically healthy
Good oral hygiene
Thick gingival biotypes
Keratinized gingiva more than 2mm
 
 
ExclusionCriteria 
Details  Smokers
Taking any medications that could affect healing
Pervious depigmentation procedures
Pregnant or lactating females
Pervious periodontal surgery within 6 months before the start of the trial
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
visual analog scale
Healing index
Epithelization test using toluidine blue.
 
3rd day
5th day
14th day  
 
Secondary Outcome  
Outcome  TimePoints 
Reoccurrence of pigmentation
 
At 30th day, 90th day, & 180th day 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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)   20/08/2024 
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="6"
Days="30" 
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  

CLINICAL EVALUATION OF GINGIVAL WOUND HEALING, POST-OPERATIVE SATISFACTION, AND RECURRENCE WITH OR WITHOUT INJECTABLE PLATELET RICH FIBRIN IN THE TREATMENT OF GINGIVAL HYPERPIGMENTATION USING DIODE LASER -A SPLIT MOUTH STUDY.

Introduction:

An aesthetically satisfying smile plays an important role in the psychological wellbeing and self-confidence. There are various factors that determine the overall aesthetic of smile design, one of the important factors is the pink aesthetic (aesthetic of the gingival tissues), which can greatly influence the overall clinical appearance of the smile. 

 

In context of depigmentation, is the fact that lasers are an effective, minimally invasive, and often painless alternative to the conventional and traditional techniques of depigmentation. Lasers of a range of wavelengths in dentistry, from the visible spectrum such as the “blue” and “green” diode lasers (440, 532 nm), near infrared diode lasers (810, 940, 980 nm), mid-infrared lasers Nd:YAG (1064 nm), have a broad affinity for pigmented chromophores, including melanin. Diode laser treatment exhibited better long-term stability of gingival color, with a lower incidence of re-pigmentation.

 

An autologous blood concentration known as i-PRF has been known for many years and primarily found in liquid form. The advantage of i-PRF is that it exhibits constant release of growth factors and promotes cell migration by announcing the expression of type I collagen and transforming growth factor mRNA.

 

The study is thus proposed to evaluate and compare the role of the i-PRF in gingival wound healing, post-operative healing, and recurrence of pigmentation after gingival depigmentation using a diode laser both clinically which has not been reported in the literature.

Aim and objective

To evaluate, and compare the post-gingival depigmentation outcome - pain, wound healing, epithelization clinically and reoccurence of pigmentation for i-PRF+ diode laser and diode laser alone:

a) For visual analog scale (VAS) 3rd and 5th day and healing index (HI) at 3rd, at 5th day and 14th day,

b) Epithelization test using toluidine blue at 5th day and 14th day.

c) Evaluation of reoccurrence of pigmentation at 30th day, 90th day, and 180th day.

Material and Methods:

1.                  10 subjects satisfying inclusion and exclusion criteria will be enrolled from the out-patient section, Department of Periodontics, Kamineni Institute of Dental Sciences, Narketpally, Nalgonda (Dist), Telangana.

2.                  After allocating the patient for the gingival depigmentation, infiltration anaesthesia with 2% lignocaine with adrenaline 1:200,000 was administered. The entire visible pigmentation was removed, exposing the underlying connective tissue using diode laser at 980nm at 1st and 2nd quadrants.

3.                  For i-PRF preparation, 10ml of whole blood without anticoagulant will be centrifuged at 700 rpm for 3 min at room temperature. After 3 mins the straw-colored liquid present at the top which is i-PRF will be collected. Using insulin syringe 1ml of i-PRF liquid will be deposited intramucosally in 1st quadrant alone (Test group).

Inclusion criteria:

•                     Ages: 16-45 years old

•                     Systemically healthy

•                     Good oral hygiene

•                     Thick gingival biotypes

•                     Keratinized gingiva >2mm

Exclusion criteria:

•                     Smokers

•                     Taking any medications that could affect healing

•                     Pervious depigmentation procedures

•                     Pregnant or lactating females

•                     Pervious periodontal surgery within 6 months before the start of the trial

Sample size: The study consists of 10 subjects which will be done as a split mouth clinical trial. (n=10).

Group I: In all the patients the gingiva of 1st quadrant will be deposited with i-PRF intramucosally after depigmentation procedure using diode laser at 980nm.

Group II: In all the patients the gingiva of 2nd quadrant depigmentation procedure using diode laser at 980nm will be done alone.

Parameters:

Following parameters will be evaluated, and compared.

a)                  For visual analog scale (VAS) at 3rd and 5th day,

b)                  Healing index (HI) at 3rd, at 5th day, and at 14th day,

c)                  Epithelization test using toluidine blue on 5th day and 14th day.

d)                  Reoccurrence of pigmentation at 30th day, 90th day, and 180th day.

 

 
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