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CTRI Number  CTRI/2017/09/009736 [Registered on: 12/09/2017] Trial Registered Prospectively
Last Modified On: 12/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treating gum diseases using LASER 
Scientific Title of Study   Comparative evaluation of Laser-Assisted New Attachment procedure and Excisional New Attachment procedure for the treatment of Periodontal Pockets. A Randomised Split Mouth Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avuluri Joshna 
Designation  Post Graduate 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem, Nellore 524003 Andhra Pradesh INDIA

Nellore
ANDHRA PRADESH
524003
India 
Phone  8500787824  
Fax    
Email  avuluri.joshna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sreenivas Nagarakanti 
Designation  Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem, Nellore 524003 AndhraPradesh INDIA

Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreenivas Nagarakanti 
Designation  Professor 
Affiliation  Narayana Dental College and Hospital 
Address  Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem, Nellore 524003 Andhra Pradesh INDIA

Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Source of Monetary or Material Support  
Self Funded (Principal Investigator) Dr.Avuluri Joshna, Department of Periodontology, Narayana Dental College and Hospital, Chithareddypalem, Nellore 524003 Andhra Pradesh INDIA  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 
Avuluri Joshna  Narayana Dental College and Hospital  Room Number 5, Department of Periodontology Narayana Dental College and Hospital, Chithareddypalem, Nellore, Pin 524003
Nellore
ANDHRA PRADESH 
8500787824

avuluri.joshna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Narayana Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Excisional New Attachment Procedure  After scaling and root planning, under adequate local anaesthesia pocket marking will be performed to delineate the depth of the incision. A scalloped, internally-bevelled, partial thick-ness incision will be made from crest of the free gingival margin to the base of pocket in the area being treated. The excised tissue and all of the granulomatous tissue within the area of the pocket will be removed with a curette. The root surfaces are then scaled and planed to a smooth, hard consistency to the base of incision. The gingival tissue is then repositioned against the tooth as closely as possible and if required the wound edges should be secured with sutures and periodontal dressing 
Intervention  Laser Assisted New Attachment Procedure  After scaling and root planning, diode laser will be first used on a setting of 4.0 W, 100-microseconds pulse duration, and 20 Hz. It is passed from gingival margin to the base of the pocket parallel to the root surface and moved laterally and apically to remove the diseased pocket epithelium and decontaminate the pocket. A second pass with the laser on to the setting of 4.0 W, 650-microseconds pulse duration, and 20 Hz was performed to form a fibrin clot and then the tissue will be compressed against the tooth for closer approximation. 
Comparator Agent  Scaling and Root Planning  Scaling and Root Planning with ultrasonic scalers 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The individuals aged 25 to 60 years.
Subjects with at least 20 natural permanent teeth
History of no periodontal treatment in last 12 months
Should have at least probing depth equal to or more than 5mm
 
 
ExclusionCriteria 
Details  Systemic diseases that could influence the outcome of periodontal therapy
Smokers
Pregnancy and Lactating women.
Poor oral hygiene and failure to comply with protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the clinical outcomes of LANAP versus ENAP and SRP procedures among study population.  1 month, 3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare patients response following ENAP and LANAP  1 month 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 1/ Phase 2 
Date of First Enrollment (India)   02/10/2017 
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)  Not Yet Recruiting 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

AIM: The aim of the present study is to evaluate the clinical effect of laser assisted new attachment procedure versus excisional new attachment procedure in the treatment of moderate periodontal pockets.

METHOD:

All the patients will be explained about the aim, nature, and design of the study along with a written informed consent for their participation before the commencement of the study.

The study is planned as a single centre, longitudinal, triple masked (investigators, subjects and statistician), randomized parallel arm design. The study duration is 6 months in which the clinical parameters will be recorded at baseline, 1 month, 3 months, 6 months

The clinical parameters for consideration includes plaque index (Silness and Loe 1964), gingival bleeding index (Muehlemann and Son 1971), pocket depth and clinical attachment level,  and healing index(landry,Turnbull and Howley), VAS

Three sites with pocket depth of 5 mm or above will be selected for the study. The selected sites will be randomized  into three groups. (Group A, B & C). The randomization will be done using a computer generated random table

Group A (control site): SRP

Group B (test site): SRP with ENAP

Group C (test site): SRP with LANAP

TREATMENT PROCEDURE:

ENAP: After scaling and root planning, under adequate local anaesthesia pocket marking will be performed to delineate the depth of the incision. A scalloped, internally-bevelled, partial thick-ness incision will be made from crest of the free gingival margin to the base of pocket in the area being treated. The excised tissue and all of the granulomatous tissue within the area of the pocket will be removed with a curette. The root surfaces are then scaled and planed to a smooth, hard consistency to the base of incision. The gingival tissue is then repositioned against the tooth as closely as possible and if required the wound edges should be secured with sutures and periodontal dressing.

LANAP: After scaling and root planning, diode laser will be first used on a setting of 4.0 W, 100-microseconds pulse duration, and 20 Hz. It is passed from gingival margin to the base of the pocket parallel to the root surface and moved laterally and apically to remove the diseased pocket epithelium and decontaminate the pocket. A second pass with the laser on to the setting of 4.0 W, 650-microseconds pulse duration, and 20 Hz was performed to form a fibrin clot and then the tissue will be compressed against the tooth for closer approximation.    

 
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