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CTRI Number  CTRI/2023/04/051757 [Registered on: 19/04/2023] Trial Registered Prospectively
Last Modified On: 13/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparative study of immediately loaded dental implants with xenograft vs allograft. 
Scientific Title of Study   IMMEDIATELY LOADED DENTAL IMPLANTS USING XENOGRAFT (BONE RING TECHNIQUE) VS ALLOGRAFT– A COMPARATIVE STUDY.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr VEERENDRA NATH REDDY 
Designation  PROFESSOR 
Affiliation  PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE,  
Address  ROOM NO 101, DEPARTMENT OF PERIODONTICS, PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, ROAD NO 5, KAMLA NAGAR , DILSUKHNAGAR.

Hyderabad
TELANGANA
500060
India 
Phone  9866199902  
Fax    
Email  veerureddy@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr VEERENDRA NATH REDDY 
Designation  PROFESSOR 
Affiliation  PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE,  
Address  ROOM NO 101, DEPARTMENT OF PERIODONTICS, PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, ROAD NO 5, KAMLA NAGAR , DILSUKHNAGAR.

Hyderabad
TELANGANA
500060
India 
Phone  9866199902  
Fax    
Email  veerureddy@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr CHANDAKA MEENAKSHI 
Designation  POST GRADUATE 
Affiliation  PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE,  
Address  ROOM NO 101, DEPARTMENT OF PERIODONTICS, PANINEEYA MAHAVIDYALAYA INSTITUTE OF DENTAL SCIENCES AND RESEARCH CENTRE, ROAD NO 5, KAMLA NAGAR , DILSUKHNAGAR.

Hyderabad
TELANGANA
500060
India 
Phone  8106604082  
Fax    
Email  meenaakshichandaka1234@gmail.com  
 
Source of Monetary or Material Support  
Panineeya mahavidyalaya institute of dental Sciences and research centre, road no 5, Kamala nagar , Dilsukhnagar , Hyderabad. 
 
Primary Sponsor  
Name  Meenakshi chandaka 
Address  h no: 5-10-108, Yapral, Secunderabad. 
Type of Sponsor  Other [self sponsor] 
 
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 Chandaka Meenakshi  panineeya mahavidyalaya institute of dental sciences and research centre  department of periodontics room no 101 first floor
Hyderabad
TELANGANA 		 8106604082

meenaakshichandaka1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1: In this group, implant is placed immediately into the fresh extraction socket with xenograft using bone ring technique.   The bone ring is introduced into the prepared defective socket under delicate pressure utilising a small bone mallet , augmenting three dimensionally, the ring is positioned such that it will be 1–2 mm above the adjacent socket walls to compensate for the anticipated bone resorption. Implant osteotomy will be performed in the centre of this disc utilising successive drills with preservation of at least 2mm of normal intact bone around the implant osteotomy. After ring placement and immobilization using a pickle fork, the final implant drill will be introduced through the central osteotomy of the bone ring to prepare the remaining apical bone of the socket for at least 3 mm. The implant will be then screwed passively through the tapped central osteotomy of the harvested ring and firmly into the prepared bone apical to the ring using a torque ratchet. The platform of the implant will be positioned 1 mm below the surface of the ring to compensate for the anticipated crestal bone resorption. Finally, the covering screw will be secured and the ring margin will be rounded using a small egg- shaped bur. Postoperative follow-up to evaluate wound healing at site will be carried out after 2 weeks. Six months postoperatively, a minimal crestal incision will be performed under local anaesthesia and a small flap will be reflected to expose the covering screw. The healing abutment will then secured and the flap closed around it to give a natural gingival appearance after healing. After 1 week the healing abutment will be removed and the transfer abutment will be secured. The impression will then taken to construct the final restoration. Finally, the fabricated ceramo-metallic crown will be permanently cemented over the final abutment.  
Comparator Agent  Group 2: In this group, implant is placed immediately with allograft placed into the extraction socket.   To prepare the socket for the implant, drills will be used. The axis of the implant will be allied with the incisal edges of the contiguous teeth or be slightly palatal to this landmark. A minimum of 2 mm apical to the interproximal and crestal bone is where the implant head will be placed and bone graft particles after preparation will be condensed into the gap, this will be followed by approximation of the flap and primary closure utilizing interrupted 3/0 braided black silk sutures.  Postoperative follow-up to evaluate wound healing at site will be carried out after 2 weeks. Six months postoperatively, a minimal crestal incision will be performed under local anaesthesia and a small flap will be reflected to expose the covering screw. The healing abutment will then secured and the flap closed around it to give a natural gingival appearance after healing. After 1 week the healing abutment will be removed and the transfer abutment will be secured. prosthetic phase: The impression will then taken to construct the final restoration. Finally, the fabricated ceramo-metallic crown will be permanently cemented over the final abutment.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  All selected patients having fresh extraction sockets with vertical and horizontal bone defects.
Patients who can understand the treatment procedure and maintenance schedule. 
 
ExclusionCriteria 
Details  Patients with any systemic disease that could affect bone healing were excluded from the study.
Patients with bone metabolic disorders.
Pregnant and lactating woman.
Patients undergoing radiation and immunosuppressive therapy.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
HEALING INDEX   2 WEEKS POST OPERATIVELY
 
 
Secondary Outcome  
Outcome  TimePoints 
PRIMARY STABILITY AND OSSEOINTEGRATION WITH XENOGRAFT AND ALLOGRAFT  BASELINE AND 6 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   N/A 
Date of First Enrollment (India)   27/04/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The clinical replacement of lost natural teeth using osseointegrated implants is one of the most significant advances in restorative dentistry. In dental implant surgery, bone grafts are used for the reconstruction and reestablishment of alveolar bone volume and to improve bone architecture for better positioning of an implant.The present study is intended to assess the use of the Bone ring technique Vs Allograft placement for vertical and horizontal bone augmentation in freshly extracted sockets with simultaneous implant placement.

XENOGRAFT(BONE RING): Bovine-derived hydroxy apatite bone replacement grafts increase the available surface area that can act as an osteoconductive scaffold due to their porosity and have a mineral content comparable to that of human bone, allowing them to integrate with host bone. They have been used with success for the treatment of intra bony defects and ridge augmentation. This is a technique of placing bovine bone ring and performing 3D reconstruction of bone defects, together with immediate implant placement into fresh extraction socket.

ALLOGRAFT: A demineralized freeze-dried bone allograft (DFDBA) is an graft composed of demineralized bone matrix (DBM). It has the ability to stimulate cell attachment, cell migration, and osteogenesis. DFDBA contains bone morphogenic protein (BMP) that causes new bone formation to take place during healing. It is therefore an effective option for bone regeneration.

 
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