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CTRI Number  CTRI/2023/09/058030 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical study to evaluate the effectiveness of laser vs suture assisted healing of wounds 
Scientific Title of Study   Comparative evaluation of efficacy of laser assisted welding and conventional silk sutures for tissue healing after periodontal surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  isha sridhar 
Designation  Post Graduate student  
Affiliation  Sri Aurobindo College of Dentistry, Indore 
Address  Room No. 5- Dept of periodontology, Sri Aurobindo College of Dentistry, Indore-Ujjain State Highway, Near MR 10 Crossing, Indore (MP)

Indore
MADHYA PRADESH
453555
India 
Phone  9589043602  
Fax    
Email  isha05sridhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajesh Kumar 
Designation  Professor 
Affiliation  Sri Aurobindo College of Dentistry, Indore 
Address  Room No. 5, Department of periodontology, Sri Aurobindo College of Dentistry, Indore-Ujjain state Highway, near MR 10 Crossing, Indore

Indore
MADHYA PRADESH
453555
India 
Phone  9229221015  
Fax    
Email  drkumar.perio78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Isha Sridhar 
Designation  Post Graduate student  
Affiliation  Sri Aurobindo College of Dentistry, Indore 
Address  Room No. 5- Dept of Periodontology, Sri Aurobindo College of Dentistry, Indore-Ujjain State Highway, Near MR 10 Crossing, Indore (MP)

Indore
MADHYA PRADESH
453555
India 
Phone  9589043602  
Fax    
Email  isha05sridhar@gmail.com  
 
Source of Monetary or Material Support  
Sri Aurobindo College of Dentistry, Indore-ujjain State Highway , Near MR 10 Crossing, Indore (MP) - 453555 
 
Primary Sponsor  
Name  Dr. Isha Sridhar 
Address  H-239 Shalimar Bunglow park, Sukhliya, Indore (MP) - 452010 
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 
Dr Isha Sridhar  Sri Aurobindo College of Dentistry  Room No. 5- Dept of Periodontology, Sri Aurobindo College of Dentistry, Indore-Ujjain State Highway, Near MR 10 Crossing, Indore (MP) - 453555
Indore
MADHYA PRADESH 		 9589043602

isha05sridhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE- Sri Aurobindo Medical College and P.G. Institute, Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laser Tissue Welding   AlbuRel (Reliance life Sciences)- 20% human albumin Aurogreen (Aurolab, India) - indocyanine green dye 25mg used as a solder for Laser Tissue Welding for a duration of 8-10 minutes per quadrant 
Comparator Agent  Sutures  3-0 conventional silk sutures for a duration of 10-15 minutes per quadrant. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with pocket probing depth of more than or equal to 5mm with 4 or more teeth involved in each quadrant after phase 1 therapy with at least 2 quadrants involved, Patients without occlusal discrepancy, Patients without tooth mobility, Motivated patients capable of maintaining oral hygiene on receiving instructions.
 
 
ExclusionCriteria 
Details  Patients with systemic diseases like diabetes, blood disorders, cardiovascular conditions, immunocompromised patients, Patients on immunosuppressants in the last 6 months, Patients with partial denture or orthodontic appliances, Patients allergic to albumin or indocyanine green dye, Smokers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Operative time for wound closure, Wound Healing assessment  Operative time for wound closure- baseline, Wound healing assessment - baseline, 3rd day, 7th day, 14th day 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque formation, gingival bleeding, post operative pain assessment  Plaque formation - baseline, 3rd day, 7th day, 14th day
Gingival bleeding - 7th day, 14th day
Post operative pain assessment - 3rd day, 7th day, 14th day 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/10/2023 
Date of Study Completion (India) 18/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/04/2024 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [isha05sridhar@gmail.com].

  6. For how long will this data be available start date provided 25-06-2024 and end date provided 25-06-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomized controlled split mouth clinical trial comparing the efficacy of laser assisted healing of wounds with the application of 20% human albumin and using indocyanine green dye as an adjunct and conventional silk sutures after periodontal flap surgery in chronic periodontitis patients. The operative time will be measured during the procedure and clinical parameters will be measured on 3rd , 7th and 14th post operative day.  
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