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CTRI Number  CTRI/2023/09/057472 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 08/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   LASER Assisted New Attachment Procedure, Excisional New Attachment Procedure and Subgingival curettage in the treatment of chronic periodontitis 
Scientific Title of Study   Evaluation of LANAP,ENAP and Subgingival curettage in the treatment of chronic periodontitis -A Split mouth Clinical 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  Sweety Sonar 
Designation  PG Resident 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Utrathia, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226029
India 
Phone  9534784500  
Fax    
Email  drsweetysonar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vinod Kumar 
Designation  Professor 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Utrathia, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226029
India 
Phone  9695910080  
Fax    
Email  dr.vinod2112@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sweety Sonar 
Designation  PG Resident 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Utrathia, Lucknow, Uttar Pradesh

Lucknow
UTTAR PRADESH
226029
India 
Phone  9534784500  
Fax    
Email  drsweetysonar@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow 
 
Primary Sponsor  
Name  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Raebareilly road, Utrathia, Lucknow, Uttar Pradesh-226029 
Type of Sponsor  Research institution and hospital 
 
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 Sweety Sonar  Sardar Patel Post Graduate Institute of Dental and Medical Sciences  Room no.7, 4th floor, Department of Periodontology
Lucknow
UTTAR PRADESH 		 9534784500

drsweetysonar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LANAP, ENAP and Subgingival curettage.  In all patients extra oral antisepsis and intra oral antisepsis will be performed with 5% povidone iodine solution and 0.2% chlorhexidine digluconate mouth rinse respectively. The operative site will be anaesthetized with 2% Lignocaine HCl with adrenaline (1:80,000) using block and infiltration techniques. For Group B i.e. patients quadrant to be treated with LANAP, an optic fibre measuring 0.3-0.4  of the soft tissue diode laser 445 nm will be placed parallel to the root surface, to carry away the epithelium lining off the pocket in coronal to apical motion and photobiomodulation will be done at 660 nm. For Group C i.e. patients quadrant to be treated with ENAP, a reverse bevel incision and mucosal flap will be reflected without exposing the alveolar bone, to allow for access to the root surfaces. The inflamed granulated and excised tissues will be removed with the help of scalers and curettes. The root will be scaled hard and smooth and will be free of calculus and the area will be flushed with normal saline to remove debris, blood clots and tissue tags the mucosal flap is then readapted in its original position.Group D i.e Patients quadrant to be treated with Subgingival curettage removal of the soft tissue lining of periodontal pocket will be done with the help of area specific curettes. Patients will be recalled at baseline, 1 and 3 months, deposits if any will be removed and oral hygiene instructions will be reinforced followed by measurement of all clinical parameter measurements and photographic evaluations. 
Comparator Agent  Scaling and Root planing (SRP)  In all patients extra oral antisepsis and intra oral antisepsis will be performed with 5% povidone iodine solution and 0.2% chlorhexidine digluconate mouth rinse respectively. The operative site will be anaesthetized with 2% Lignocaine HCl with adrenaline (1:80,000) using block and infiltration techniques. For Group A patients quadrant to be treated with SRP only ultrasonic scaling and root planing will be done with the help of ultrasonic scaler, scaler tips and area specific curettes. Patients will be recalled at baseline, 1 and 3 months, deposits if any will be removed and oral hygiene instructions will be reinforced followed by measurement of all clinical parameter measurements and photographic evaluations. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1- Patient diagnosed with chronic periodontitis.
2- Age between 35-60 years.
3- Teeth selection: All the teeth diagnosed with chronic periodontitis on clinical and radiographic evaluation.
4- The sites should exhibit clinical evidence of probing pocket depth of ≥ 5mm and clinical attachment loss ≥ 3mm.
5- Systemically healthy patients.
6- Patients with established willingness and ability to perform adequate oral hygiene
 
 
ExclusionCriteria 
Details  1- Subjects who have received periodontal flap/regenerative therapy within the past 1 year
2- Patients who have received antibiotic therapy within the past six months
3- Pregnant and lactating patients
4- Smokers and tobacco chewers
5- Patients who demonstrate poor oral hygiene maintenance after Phase I therapy
6- Tooth with gingival recession and endodontic-pulpal involvement.
7- Systemic illness known to affect the outcomes of periodontal therapy; such as uncontrolled diabetes mellitus, cardiac diseases, immune-compromised (e.g., HIV individuals, under radiotherapy), patients taking medications such as corticosteroids or calcium channel blockers, which are known to interfere with periodontal wound healing
8- Patients with any known allergy to drugs
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The possible outcome of this study will be to see reduction in Probing depth and improvement in Clinical attachment level with ENAP and LANAP in chronic periodontitis cases  Baseline
1 Month
3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess gingival inflammation  Baseline
1 Month
3 Months 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
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 2 
Date of First Enrollment (India)   20/09/2023 
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="2"
Months="0"
Days="0" 
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   The bacterial composition of the microbial plaque biofilm is the most important causation factor for chronic periodontitis. Scaling and root planning (SRP) along with various flap surgical procedures have been performed to reduce the microbial burden of the plaque biofilm. Laser therapy can be used as an adjunct to the conventional therapy without any major side effects, it decontaminates the soft tissue wall as well as root surfaces of the periodontal pocket by promoting bacterial reduction. The diode laser is a semiconductor and the most common diode wavelengths used in dentistry are 610 nm to 980 nm. It can be operated in both continuous wave and pulsed wave modes. The ENAP has been described as “curettage with a scalpel”. Epithelium of the soft pocket wall is excised by means of reverse bevel incision, a mucosal flap is reflected without exposing the alveolar bone, to allow for access to root surfaces then readapted in its original position with interdental sutures. The main aim of subgingival curettage is to remove all subgingival calculus deposits, remove granulation tissues in pockets, to cause haemorrhage which can reduce oedema and congestion of gingiva and remove the epithelial linings of the pockets. Non-surgical therapy show decreased probing pocket depth, gain in clinical attachment level been most effective means of treating periodontal disease. 

In this study eighteen patients diagnosed with periodontitis showing pocket depth >5mm and Clinical attachment loss >3mm will be selected from department of Periodontology, SPPGIDMS, Lucknow. The patients will be divided into four groups. Group A (SRP), Group B (LANAP), Group C (ENAP) and Group D (subgingival curettage). Clinical periodontal parameters pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), will be checked at baseline, 1 month and 3 months after treatment.

This study will help us know the efficacy of LASER, ENAP and subgingival curettage for the treatment of chronic periodontitis patients. We anticipate that this will enable new or improved treatment of chronic periodontitis.
 
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