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CTRI Number  CTRI/2023/09/057332 [Registered on: 06/09/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Treatment of Periodontal bony defect using various bone graft 
Scientific Title of Study   Comparison of Injectable Biocomposites AND Hydroxyapatite Bone Cement in the Treatment Of Periodontal Intrabony Defects 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Himani Tripathi 
Designation  PG Resident 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Periodontology, Fourth floor, Room no 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Lucknow

Lucknow
UTTAR PRADESH
226029
India 
Phone  9792320403  
Fax    
Email  tripathihimani260@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ajita Meenawat 
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, Lucknow

Lucknow
UTTAR PRADESH
226025
India 
Phone  9307847070  
Fax    
Email  ajita.meenawat@gmail.com  
 
Details of Contact Person
Public Query  
Name  Himani Tripathi 
Designation  PG Resident 
Affiliation  Sardar Patel Post Graduate Institute of Dental and Medical Sciences 
Address  Department of Periodontology, Fourth floor, Room no 7, Sardar Patel Post Graduate Institute of Dental and Medical Sciences, Raebareilly road, Lucknow

Lucknow
UTTAR PRADESH
226029
India 
Phone  9792320403  
Fax    
Email  tripathihimani260@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 of Dental and Medical Sciences 
Address  RAEBAREILLY ROAD LUCKNOW-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 HIMANI TRIPATHI  SARDAR PATEL POST GRADUATE INSTITUTE OF DENTAL AND MEDICAL SCIENCES  ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY FOURTH FLOOR
Lucknow
UTTAR PRADESH 		 9792320403

tripathihimani260@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy individuals diagnosed with periodontal osseous intrabony defect on clinical and radiographic evaluation with Probing Depth more than 4 mm and an intrabony component more than 3 mm 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIOCOMPOSITES  The biocomposites are blends of beta tricalcium phosphate compounds (beta TCP) and calcium sulphate (CS). The Injectable biocomposites is specifically formulated to provide a balance of osteoconductive scaffold strength and persistence in the body with optimum handling, workability and remodeling. The beta tricalcium phosphate act as an osteoconductive scaffold and facilitates bone healing and remodelling that fully absorbs at a rate that complements bone healing. The calcium sulfate plays role of osteoconductive carrier which provide structure and absorbs quickly to create pores for early bone ingrowth. The injectable formulation presents a closed-mixing system which increases surgical case efficiency by shortening preparation time and extending workability 
Comparator Agent  HYDROXYAPATITE  HA is osteoconductive and serve as a scaffolding upon which host bone can grow.The rationale for using HA bioactivity is related to its osteoconductive properties, which allow apposition and migration of osteoblasts at the material surface. HA is known to be able to bond directly to bone. HA alone has been used with adequate clinical success rates in dentistry and maxillofacial surgery to support alveolar bone regeneration 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Patient age between16-40 years diagnosed with periodontitis
2.Teeth selection All the teeth diagnosed with periodontal osseous intrabony defect Two or three wall defect on clinical and radiographic evaluation
3.PD more than or equal to 4 mm and an intrabony component more than or equal to 3 mm
4.The depth of the intraosseous component of the defect was evaluated clinically and
radiographically during the screening phase but it had to be confirmed during
surgery
5.Systemically healthy patients
6.Patients with established willingness and ability to perform adequate oral hygiene
 
 
ExclusionCriteria 
Details  1. Heavy smoking (more than 10 cigarettes)
2. Presence of underlying medical conditions such as immunosuppression or diabetes
pregnancy and medically compromised conditions that would put the patient at risk
for periodontal surgery 
 
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 outcome expected will be to compare the
regenerative capacity of injectable biocomposites & granular form of Hydroxyapatites in
an adjunct with OFD in treatment of intrabony defects. 		 Baseline
3 months
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
the secondary outcome is radiographic evaluation of the bone fill & bone density post operative in treatments of intrabony defects.  6 months post operative 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/09/2023 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  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 (Others) - 

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 14-08-2023 and end date provided 14-08-2028?
    Response (Others) - 

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Periodontitis is an inflammatory disease of the periodontium which elicits an immune response resulting in the loss of supporting structures of the teeth. The bone loss which is induced by periodontitis i.e. osseous defects occur either single or in different combination forms. Intrabony osseous defect is defined as a “periodontal defect within the bone surrounded by one, two or three bony walls or a combination”. Treatment with grafting modalities, xenogenic or alloplastic osteoconductive materials, such as bovine bone-derived mineral, coralline calcium carbonate, calcium-layered composite of poly-methyl-methacrylate and poly-hydroxyl-ethyl-methacrylate, hydroxyapatite, bioactive glass and tricalcium phosphate are options. Bone graft is use to fill the defect, supporting and promoting new bone formation, through its use as mechanical scaffold and provides a structure for new cells to form new bone growth in the healing process. Hydroxyapatite cement (HAC) has been extensively studied as the bone grafting material in periodontal regeneration. The biocompatibility, osteoconductive nature and resorptive properties of HAC suggest it has potential to function as a successful bone substitute material. biocomposites (BC) such as beta tricalcium phosphate and calcium sulfate represent a unique bi-phasic composition with a negative charged surface. This property stimulates bone cell activity by harnessing key proteins, osteoblast adhesion and proliferation. In this study thirty patients diagnosed with periodontitis showing pocket depth >5mm and radiographic evidence of vertical/ angular bony defects will be selected from Department of Periodontology, SPPGIDMS, Lucknow and will be allocated randomly into two groups. Groups A (biocomposites + open flap debridement) and Group B (hydroxyapatite cement + open flap debridement). Clinical periodontal parameters like probing pocket depths (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and radiographic assessment of the defect will be evaluated at baseline, 3 and 6 months after treatment. The present study will evaluate and compare the efficacy of injectable biocomposites and HAC in periodontal regeneration. We anticipate that this will enable improved treatment of periodontal osseous defects. 
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