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CTRI Number  CTRI/2025/05/087259 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to Compare How Well Surgical Microscopes and Special Glasses (Loupes) Help in Cleaning Teeth and Improving Gum Health in People with Gum Disease 
Scientific Title of Study   Impact of surgical Microscopes Vs Ergonomic Loupes(Admetec TM) on root planning precision and clinical outcomes in Periodontal therapy: A Randomized Controlled 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 Thota Saranya 
Designation  Postgraduate Student  
Affiliation  Vishnu Dental College  
Address  Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  7036356905  
Fax    
Email  thotasaranya23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gautami S Penmetsa 
Designation  Professor and HOD 
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  gautami.ps@vdc.edu.in   
 
Details of Contact Person
Public Query  
Name  Dr P Anil Kumar 
Designation  Reader 
Affiliation  Vishnu Dental College 
Address  Block 3, Room 4,Department of Conservative Dentistry and Endodontics, Vishnu Dental College, Vishnupur ,Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9959680799  
Fax    
Email  anilkumarpulidindi@vdc.edu.in  
 
Source of Monetary or Material Support  
Vishnu Dental College, Vishnupur , Bhimavaram-534202, West Godavari District 
 
Primary Sponsor  
Name  Dr Thota Saranya  
Address  Block 2, Room No 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 
Dr Thota Saranya   Vishnu Dental College  Block 2 Room No 7 Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram West Godavari ANDHRA PRADESH
West Godavari
ANDHRA PRADESH 		 7036356905

thotasaranya23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vishnu dental College   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  Ergonomic loupes  Patients diagnosed with chronic periodontitis based on 2017 classification of periodontal diseases Stage II or III will be done root planing under ergonomic loupes with use of curettes. 
Comparator Agent  Surgical Operating microscope  Patients diagnosed with chronic periodontitis based on 2017 classification of periodontal diseases Stage II or III will be done root planing under surgical operating microscope 3.5X with use of curettes. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with chronic periodontitis based on 2017 classification of periodontal diseases Stage II or III.
2. Medically healthy individuals without systemic conditions affecting periodontal healing
3. Patients with at least 20 natural teeth
4.Patients with a plaque index less than or equal to 2 after initial oral hygiene instructions


 
 
ExclusionCriteria 
Details  1. Patients with uncontrolled systemic diseases (e.g., diabetes, hypertension, immunocompromised states).
2. Use of anti-inflammatory drugs, antibiotics, or anticoagulants within 3 months prior to the study.
3. Pregnant or lactating women.
4.Patients who have received periodontal treatment within the last 6 months.
5.Current smokers or chewing tobacco users.
6.Known allergy to local anesthetics or any material used in the procedure.
7.Patients with psychiatric disorders, cognitive impairment, or any condition affecting the ability to follow instructions or attend follow-up.
8. Presence of fixed prostheses, orthodontic appliances, or implants in the study sites that could interfere with evaluation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Probing pocket depth   Baseline and 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Gingival Index, Plaque index  Baseline and 4 weeks  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/06/2025 
Date of Study Completion (India) 10/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary   The success of periodontal therapy always depends on better visual access and debridement which are prerequisites for achieving a clean and smooth root surface in attaining new attachment. Magnification is something which provides good hand-eye coordination resulting in better treatment outcomes.The present study aims to evaluate the precision of root planing with usage of Surgical operating microscope and Ergonomic loupes.60 subjects falling under the inclusion criteria will be randomized into 2 groups and root planing will be done.30 individuals will be treated under Surgical operating microscope and 30 individuals will be treated under ergonomic loupes(Admetec TM). Plaque index, Gingival Index and Probing pocket depth will be assessed at baseline and 4 weeks. 
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