FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/12/060432 [Registered on: 01/12/2023] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effectiveness of different artificial bone particles in the treatment of severe gum-bone disease 
Scientific Title of Study   Comparative Clinical and Radiographic Evaluation of G-boneâ„¢ (Hydroxyapatite) and G-Graftâ„¢ (Hydroxyapatite with Collagen) as Bone Graft Material in the Treatment of Intrabony Defects in Chronic Periodontitis Patients – A Randomized Clinical Trial 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srishty Sharma 
Designation  First Year Post Graduate MDS, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  9667896855  
Fax    
Email  srishtyesic@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mala Dixit Baburaj 
Designation  head of department, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srishty Sharma 
Designation  First Year Post Graduate MDS, Department of Periodontics 
Affiliation  Nair Hospital Dental College 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India


MAHARASHTRA
400008
India 
Phone  9667896855  
Fax    
Email  srishtyesic@gmail.com  
 
Source of Monetary or Material Support  
NAIR HOSPITAL DENTAL COLLEGE, MUMBAI 400008 
 
Primary Sponsor  
Name  Dr Srishty Sharma 
Address  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India 
Type of Sponsor  Other [Self funded] 
 
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 Srishty Sharma  Nair Hospital Dental College  Room no. 201, Department of Periodontics Nair Hospital Dental College, Mumbai Maharashtra, 400008 India Mumbai MAHARASHTRA 400008 India
Mumbai
MAHARASHTRA 
9667896855

srishtyesic@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nair Hospital Dental College Institutional Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  G-bone  hydroxyapatite bone graft material 
Comparator Agent  G-graft  Hyrdoxyapatite with Collagen 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients in the age group between 30-60 yrs. 2)Patients
diagnosed with Chronic Periodontitis.
3)Patients who are
non-smokers or do not consume tobacco in any other form.
4)Patients are in good systemic health with no contraindication to
periodontal surgery
5) Patients having pocket depths >5mm,
intraosseous defects > 3mm and with radiographic evidence of
vertical / angular bone loss in the affected sites.  
 
ExclusionCriteria 
Details  1) One-walled osseous defects.
2) Patients suffering from any systemic diseases or with a
compromised immune system.
3) Patients who had received any type of periodontal therapy for the
past 6 months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or
Chlorhexidine or any other medicine used in the study.
6) Patients showing unacceptable oral hygiene compliance during /
after Phase I periodontal therapy.
7) Patients taking any drug known to cause gingival enlargement.
8) Pregnant and/or lactating mothers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.)
(Tureskey-Gilmore-Glickman Modification of
Quigley Hein)
2. Gingival Index (G.I.) (Loe & Silness, 1963)
3. Probing Pocket Depth (PPD)
4. Clinical Attachment Level (CAL)
 
Baseline, 1 Month, 3 Months, 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Measurement of bone fill from CEJ to the base of
the defect using radiovisiography (RVG) with
EzDenti imaging software 
Baseline, 1 Month, 3 Months, 6 Months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) 06/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  
INTRODUCTION Bone is a dynamic organ that can regenerate and bone grafting is a dynamic phenomenon. The two types of bone grafts frequently used in are autografts and allografts. Autograft bone is transplanted from another part of the recipient’s body.[1] Autologous bone remains the gold standard, but requires a second surgical site that can result in additional pain and complications, is limited in quantity and increases the cost of the procedure. The bone grafted from genetically non identical members of the same species is known as Allograft bone. Its advantage is that it obviates the morbidity with donor-site complications and is readily available in the desired size, shape and quantity. Fresh-frozen or demineralized freeze-dried allograft bone has also been used, however due to rapid rate of resorption does not make it ideal for large bony defects. Recently, xenograft materials are gaining more popularity with good success rate as bone graft substitutes. These grafts are procured from one individual and transplanted into another individual of a different species and are usually derived from porcine, coral, and bovine sources[1].

Collagen as an osteoconductive material is due to its osteoconductive property and when it is used in combination with osteoinductive carriers like hydroxyapatite or tricalcium phosphate. These composites are mixed with autologous bone marrow which subsequently provides osteoprogenitor cells and other growth factors.[1] Hydroxyapatite is a biocompatible ceramic produced through a high temperature reaction and is highly crystalline form of calcium phosphate. The nominal composition of this mixture is Ca10 (PO4)6 (OH) 2 with a calcium-to phosphate atomic ratio of 1.67. The most unique property of this material is chemical similarity with the mineralized phase of bone; this

 
similarity accounts for their osteoconductive potential and excellent biocompatibility. Hydroxyapatite is available in various physical forms[2].

Bone formation, graft incorporation varies with each. HA in ceramic and crystalline form is slow in resorption and bone formation, where as non-ceramic, non-crystalline form is fast in resorption and in bone formation. A three-dimensional collagen-HAP (CHAP) nanocomposite scaffold was prepared by co-precipitation method (phosphoric acid solution mixed with collagen molecules and calcium hydroxide solution) through a self-organization process, which was then freeze- dried to create pores followed by a dehydrothermal crosslinking.[3]

Indeed, both collagen type I and hydroxyapatite were found to enhance osteoblast differentiation (Xie et al., 2004), but combined together, they were shown to accelerate osteogenesis. A composite matrix when embedded with human-like osteoblast cells, showed better osteoconductive properties compared to monolithic HA and produced calcification of identical bone matrix (Serre et al., 1993; Wang et al., 1995). In addition, Col-HA composites proved to be biocompatible both in humans and in animals (Serre et al., 1993; Scabbia and Trombelli, 2004). These composites also behaved mechanically in a superior way to the individual components. The ductile properties of collagen help to increase the poor fracture toughness of hydroxyapatites. The addition of a calcium/ phosphate compound to collagen sheets gave higher stability, increased the resistance to three-dimensional swelling compared to the collagen reference (Yamauchi et al. 2004) and enhanced their mechanical ‘wet’ properties (Lawson and Czernuszka, 1998).[4]

The BH particles incorporated with a porcine type-I collagen matrix (BHC) can be stabilized without dissipation like a hard sponge, which allow to adapt and condense into the irregular defects. When it gets wet, it is softened and has favorable manageability. A number of preclinical and clinical studies indicated that BHC grafting enhanced periodontal regeneration in periodontal intrabony defects[5]

Recently, Surgiwear has developed xenograft in the name of G-Graftâ„¢ It is natural Hydroxyapatite with natural collagen and with naturally occurring trabecular pattern. It is very useful for bone repair and replenishment. G-Graftâ„¢ is made of natural low crystalline Hydroxyapatite with collagen. It is available in form of granules, dowels and blocks. The shape can be changed by using Gigli saw and bone nibblers.[1]
Wahl DA et al. proposed that, the composite of Hydroxyapatite & Collagen (G-Grafâ„¢) may lead to earlier bone regeneration & greater density of the mature bone. Araujo M et al. in a study also found that de novo hard tissue formation after 3 months, particularly in the cortical region of the extraction site using of hydroxyapatite /collagen composite
(Bio-Oss Collagen) on healing of an extraction socket of dogs. Johnson KD et al, in a study reported that Collagen hydroxyapatite composite was better in comparison to tricalcium phosphate and hydroxyapatite used alone , in healing 2.5 cm bony defect created surgically in a canine radius model.[2]
Although hydroxyapatite is the most widely studied stiff scaffold material, the frequency of its clinical use is less than 10% of all bone grafting procedures due to its unstable fixation and insufficient interaction with host tissues. Instead, hydroxyapatite composites (e.g., hydroxyapatite plus collagen derivatives) have been developed to mimic biochemical and biomechanical properties of natural bone in order to enhance osteointegration and graft healing for potential biomedical applications.

The rapidly evolving technology enables the development of biomimetic nanocomposite biomaterials that fulfil the current requirements of an improved bone scaffold.Dentistry Section Three biologic processes are involved in new bone formation within a bone graft - Osteogenesis, Osteoconduction and Osteoinduction. The main purpose of this present study was to radiologically assess and compare the regenerative potential of hydroxyapatite with Collagen (G-Graftâ„¢) & hydroxyapatite (G-Boneâ„¢).
 
Close