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
|
|
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
|
|
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. |