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CTRI Number  CTRI/2023/08/056711 [Registered on: 21/08/2023] Trial Registered Prospectively
Last Modified On: 21/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Implant Placement With Reverse Drilling Technique 
Scientific Title of Study   Evaluation Of Implant Stability And Crestal Bone Levels Of Dental Implants Placed Using Conventional And Reverse Drilling Protocol-A Randomized Control 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 Syed Afzal 
Designation  Post Graduation Student 
Affiliation  Kamineni Institute Of Dental Sciences 
Address  Kamineni Institute Of Dental Sciences Department Of Periodontics Room Number 6 Narketpally Nalgonda District Telangana India 508254

Nalgonda
TELANGANA
508254
India 
Phone  8919440934  
Fax  08682272296  
Email  afzalabbu007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Juliet Josephin 
Designation  Associate Professor 
Affiliation  Kamineni Institute Of Dental Sciences 
Address  Kamineni Institute Of Dental Sciences Department Of Periodontics Room Number 6 Narketpally Nalgonda District Telangana India 508254

Nalgonda
TELANGANA
508254
India 
Phone  9989183060  
Fax  08682272296  
Email  periomds@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Syed Afzal 
Designation  Post Graduate Student 
Affiliation  Kamineni Institute Of Dental Sciences 
Address  Kamineni Institute Of Dental Sciences Department Of Periodontics Room Number 6 Narketpally Nalgonda District Telangana India 508254

Nalgonda
TELANGANA
508254
India 
Phone  8919440934  
Fax  08682272296  
Email  afzalabbu007@gmail.com  
 
Source of Monetary or Material Support  
Kamineni Institute Of Dental Sciences Individuals From Out Patient Section Department Of Periodontics Kamineni Institute Of Dental Sciences Department Of Periodontics Narketpally Nalgonda District Telangana India 508254 
 
Primary Sponsor  
Name  Dr Syed Afzal 
Address  Kamineni Institute Of Dental Sciences Department Of Periodontics Narketpally Nalgonda District Telangana India 508254 
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 Syed Afzal  Kamineni Institute Of Dental Sciences  Department Of Periodontics Room Number 6 Narketpally Nalgonda District Telangana India 508254
Nalgonda
TELANGANA 
8919440934

afzalabbu007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kamineni Institute Of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placement Of Implant Using Conventional Drilling Protocol  All Control Groups Are Treated With Conventional Drilling Protocol Of Implant Placement And Crestal Bone Levels And Implant Stability Are Evaluated At Base Line And 3 Months  
Comparator Agent  Reverse Drilling Protocol Of Implant Placement  All Test Groups Are Treated With Reverse Drilling Protocol Of Implant Placement And Crestal Bone Levels And Implant Stability Are Evaluated At Base Line And 3 Months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Who Required An Implant In The Single Edentulous Sites In Either Jaw
Absence Of Restoration/ Prosthesis Adjacent To Edentulous Site
Healed Extraction Socket Site Greater than Or Equal to 3 months 
 
ExclusionCriteria 
Details  Patients With Systemic Diseases
Smokers
Pregnant Or Lactating Women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Implant Stability And Crestal Bone Levels  1 Month
3 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Increased Implant Stability And Crestal Bone Levels  3 Months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Phase 3 
Date of First Enrollment (India)   31/08/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="7"
Days="15" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

NEED FOR THE STUDY:

Dental implantology aims at functional and esthetic rehabilitation of a patient affected by complete or partial edentulism.  

The success of implant therapy depends on the attainment of osseointegration, osseointegration is the direct structural and functional connection between bone and the surface of an implant. The surgical technique of implant placement also plays a vital role in establishing osseointegration.

Various drilling protocols have been established for implant placement namely conventional, under preparation or Osseo densification and reverse drilling protocol.

Conventional drills are used to perform osteotomy in the alveolar bone during dental implant surgery. Abundant bone dust will be produced during the process, it seems disgrace to wash away these precious autogenous bones with cooling water.

There have been numerous methods in the past trying to collect these bone dust, for example, the bone trap connected to the saliva tube to collect bone chips from suction, or a low-speed drilling without irrigation to collect the bone chips.

Recently, there is a new model adjustment in the osteotomy preparation named Osseo densification, which was designed through a counterclockwise rotation using uniquely designed burs that promotes lateralization of autogenous bone in to the surrounding cancellous structure and expands the surrounding osseous environment to provide three major effects.

First, it claims to collect these bone dust on the spot and fill them around the implant socket in the purpose of increasing bone density and increasing the initial stability of the implant.  Second, because of reverse drilling technique, it has the effect of alveolar ridge split at the same time. Third, it is used in the posterior area of the upper jaw, it can push the collected bone particles into the maxillary sinus and achieve the effect of sinus lifting simultaneously.

The scientific data regarding the reverse drilling protocol and its comparison to conventional drilling protocol is scant. Hence, the study is designed to evaluate and compare the reverse and conventional drilling protocol.

REVERSE DRILLING PROTOCOL:

In reverse drilling protocol the lance drill will be placed in clock wise direction.

The remaining sequential drilling will be done in counter clock wise direction with 30NCM torque.

 
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