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CTRI Number  CTRI/2024/06/069433 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Evaluation of clinical and 3 D radiographic outcomes in periodontal defects treated by 2 different artificial bone substitutes  
Scientific Title of Study   Evaluation of clinical and 3-D imaging outcomes in infrabony and grade II furcation defects treated by stickybone and anorganic bovine bone matrix - a hospital based split mouth one year longitudinal 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  Dr Shanmuga priya S 
Designation  Postgraduate student 
Affiliation  Govt.dental college,kozhikode 
Address  Room no.38 Department of Periodontics Govt.dental college, kozhikode

Kozhikode
KERALA
673008
India 
Phone  7010918677  
Fax    
Email  priyasp2791@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Harikumar K 
Designation  Professor and HOD 
Affiliation  govt.dental college,kozhikode 
Address  room no.38 department of periodontics govt.dental college,kozhikode

Kozhikode
KERALA
673008
India 
Phone  9847128617  
Fax    
Email  harisindhu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Drshanmuga priya s 
Designation  Postgraduate student 
Affiliation  govt.dental college,kozhikode 
Address  room no.38 department of periodontics govt.dental college,kozhikode

Kozhikode
KERALA
673008
India 
Phone  7010918677  
Fax    
Email  priyasp2791@gmail.com  
 
Source of Monetary or Material Support  
Dr.shanmuga priya.S Government dental college,kozhikode-673008 
 
Primary Sponsor  
Name  Dr Shanmuga priyaS 
Address  Room no.38 dept of periodontics govt.dental college,kozhikode-673008 
Type of Sponsor  Other [Personal funding] 
 
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 
Drshanmuga priya  Govt.dental college kozhikode  Room no.38 Dept of periodontics Kozhikode-673008
Kozhikode
KERALA 		 7010918677

priyasp2791@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee govt dental college kozhikode  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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with two infrabony defect in the same mouth with a minimum intrabony component of atleast 3mm confirmed clinically and radiographically
2 Patients with two Grade II maxillary or mandibular 1st molar furcation defects in the same mouth with atleast 3mm intrabony component confirmed clinically and radiographically.
3 Patients with good oral hygiene maintenance after phase I therapy 
 
ExclusionCriteria 
Details  1 Patients having sites with visible gingival recession
2 Patients who are not willing to participate in the study
3 Medically compromised patients
4 Pregnant and lactating women
5 Patient who have habit of smoking and consuming alcohol
6 Patients who underwent surgical periodontal therapy before 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1 Probing pocket depth(PPD)-from gingival margin to the base of the pocket
Clinical attachment level(CAL)- from CEJ to the base of the pocket
Gingival margin level(GML)- from CEJ to free gingival margin
2 Bone fill- From cementoenamel junction to the base of the defect 		 Probing pocket depth,clinical attachment level,gingival marginal level-baseline,3month,6month,1 year
2 bonefill- baseline,1year 
 
Secondary Outcome  
Outcome  TimePoints 
1 Patient reported outcome measures using a validated questionnaire
2Changes in inflammation assessed by using sulcular bleeding index
3 Healing outcome- tissue color,bleeding on palpation,granulation tissue,incision margin,suppuration evaluated by landry et.al healing index 		 1PROM -after 1Week
2changes in inflammation- baseline,3month,6month,1year
3 Healing outcome- after 1 week 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/07/2024 
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="0"
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   I will be conducting a study titled evaluation of clinical and 3 Dimensional imaging outcomes in infrabony and grade II furcation defects treated by stickybone and anorganic bovine bone matrix- a hospital based split mouth one year longitudinal study in the department of periodontics with a sample size of 40 patients, primary outcome variables are Probing pocket depth,clinical attachment level,gingival marginal level,bone fill assessed in the timepoints at baseline ,during surgery and after surgery  
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