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CTRI Number  CTRI/2024/05/066699 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 29/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical study to evaluate laser light on colour and dimensions on free gingival graft  
Scientific Title of Study   Effects of Er:YAG laser vs Surgical De-Epithelization of Free Gingival Grafts on Dimensional Changes and Esthetics-A Three Arm Controlled Clinical 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 Rayapati lois sowmya Abhinandhitha 
Designation  I mds post graduate 
Affiliation  vishnu dental college 
Address  Block 2, Room 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  8074678475  
Fax    
Email  nandhitha.abhi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sruthima NVS Gottumukkala 
Designation  professor 
Affiliation  vishnu dental college 
Address  Block 2, Room 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9492293808  
Fax    
Email  sruthima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gautami s penmetsa 
Designation  Head of the department 
Affiliation  vishnu dental college 
Address  Block 2, Room 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram.

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9951011618  
Fax    
Email  gautamipenmetsa@gmail.com  
 
Source of Monetary or Material Support  
Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh 
 
Primary Sponsor  
Name  Dr Rayapati lois sowmya Abhinandhitha 
Address  Block II, Room 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram. 
Type of Sponsor  Other [Self] 
 
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 
Rayapati lois sowmya abhinandhitha  vishnu dental college  Block II, Room 7, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram.
West Godavari
ANDHRA PRADESH 		 8074678475

nandhitha.abhi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics commitee,Vishnu dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional free gingival graft  Conventional Free Gingival Graft will be performed in patients with class I/II/III gingival reccession.clinical evaluation will be done at 3 months and 6 months 
Intervention  In test group 1 Surgical de-epithelization In test group 2 Er:YAG LASER de-epithelization  In the Test group 1 Surgical de-epithelization of free gingival graft will be performed in patients with miller’s class I/II/III recession.In test group 2 de-epithelization will be performed with Er:yag laser in patients with miller’s class I/II/III recession.After the treatment patient will be asked to return to the study center at baseline,1 week,1 month,3 months and 6 months for evaluating dimensional changes,colour match and healing index. 
 
Inclusion Criteria  
Age From  25.00 Day(s)
Age To  50.00 Day(s)
Gender  Both 
Details  1. Patients with periodontal health in a reduced periodontium Non periodontitis/ stable periodontal health (2017 Classification) with Miller’s class I, II & III gingival Reccesion, Attached gingiva less than 1mm will be selected
2. Age-25 to 50 years
3. Presence of Miller’s class I / II /III gingival recession in maxillary/mandibular anteriors
4. Full mouth plaque score (FMPS) of less than 20%. (O’leary plaque index,1972)
5. Full mouth gingival bleeing score(FMBS) of less than 20%.
6. Attached gingiva less than 1mm 
 
ExclusionCriteria 
Details  1. Patients with uncontrolled systemic diseases
2. Autoimmune,Infectious,Inflammatory conditions, or Intake of anticoagulants
3. Pregnancy or lactating women
4. Smokers
5. Patients with malocclusion,traumatic occlusion which cannot be corrected
6. Presence of mobility 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Graft length
Graft width
Graft thickness
Graft area
Color match 		 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Healing index
Degree of de-epithelization 		 1 week and 1 month
Baseline and 1 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/05/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 aim of the study is to evaluate and compare the effect of Er:YAG LASER vs Surgical de-epithelization of free gingival grafts on Dimensional changes and colour match after gingival augmentation.

A total of 30 Patients visiting Vishnu Dental college with miller’s class I/II/III gingival recessions will be recruited. A written informed consent will be obtained from all the patients and they will be divided into three groups, Control and two test group. In the control group,free gingival graft will be performed in patients with miller’s class I/II/III recession. In the Test group 1 surgical de-epithelization of free gingival graft will be performed in patients with miller’s class I/II/III recession.In test group 2 de-epithelization will be performed with Er:yag laser in patients with miller’s class I/II/III recession. After the treatment Graft Width(GW),Graft length(GL),Graft thickness(GT),Graft dimension/Graft Area(GD) assessment will be done at baseline, 1 month, 3 months and at 6 months. Color match with 21 Numeric Rating Scale- will be assessed at 3 months and 6 months.Healing Index (landry healing index) at 1 week and 1 month. Degree of De-epithelization with toluidine blue will be assessed at baseline and 1 week. After the treatment patient will be asked to return to the study center at baseline,1 week,1 month,3 months and 6 months for dimensional changes,colour match and healing index. the data will be analysed individually for all the patients .there is no conflict of interest. 
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