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CTRI Number  CTRI/2021/01/030194 [Registered on: 01/01/2021] Trial Registered Prospectively
Last Modified On: 04/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect on surrounding structures by two different joints between artificial root and artificial tooth 
Scientific Title of Study   Evaluation of peri implant soft and hard tissues between internal hexagonal and internal conical type of implant abutment connection- A randomised controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aditi Mishra 
Designation  Junior resident-1 
Affiliation  King Georges Medical College, U.P. 
Address  Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh
King Georges Medical College,Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  7599114676  
Fax    
Email  aditiara33@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aditi Mishra 
Designation  Junior resident-1 
Affiliation  King Georges Medical College, U.P. 
Address  Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh
King Georges Medical College,Lucknow, Uttar Pradesh

UTTAR PRADESH
226003
India 
Phone  7599114676  
Fax    
Email  aditiara33@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ramashanker Siddarth 
Designation  Professor 
Affiliation  King Georges Medical College, U.P. 
Address  Department of Prosthodontics, Crowns and Bridges, Sixth floor, New dental building, King Georges Medical College,Lucknow, Uttar Pradesh
King Georges Medical College,Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9450361106  
Fax    
Email  ramashanker09@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics, crown and Bridge, New dental building, King George Medical College,Lucknow 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aditi Mishra  King George Medical College  Dept. of Prosthodontics, Crown & Bridge, Sixth floor, New dental building, King Georges Medical College, Lucknow, Uttar Pradesh
Lucknow
UTTAR PRADESH 
7599114676

aditiara33@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King Georges Medical college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Delayed occlusal loading of implants placed in properly healed single teeth edentulous site  After delayed occlusal loading, the peri-implant tissue is evaluated for next 12 months 
Comparator Agent  Implant-Abutment Connection  Two implant abutment connections- Internal Hexagonal and Internal Conical will be compared for peri-implant tissue inflammation using probing depth, bleeding on probing, IL-1 Beta levels in PICF and marginal bone loss 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient in the age group of 18years or above who will be able to understand the procedure and be able to provide informed consent to participate in it.
2. Partially edentulous in posterior region(molar and premolar).
3. Patients with simplified oral hygiene index score less than 3
4. Patients having sufficient bone to allow optimal implant placement without the need of bone augmentation or recontouring and having sufficient distaance from vital tissues(2mm).
5. Presence of keratinized tissue more than 2mm
6. Stable posterior occlusion
7. Presence of adjacent teeth (1.5mm) 
 
ExclusionCriteria 
Details  1. Patient with a history of systemic disease that precludes standard implant therapy.
2. Patients having parafunctional habits
3. Patient with a current daily smoking habit or chewing tobacco and with a history of drug abuse or alcoholism within past years
4. Pregnant or lactating mother
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Levels of Crestal bone loss
Levels of IL-1beta
Change in probing depth
Change in bleeding on probing index 
parameters will be recorded during the time of delivery of prosthesis
3 months after occlusal loading
6 months after occlusal loading
12 months after occlusal loading 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Dental implant treatment is widely used to reconstruct functional and aesthetic problems in partially and fully edentulous patients. However, implant-prosthetic treatment is not free of possible complications and limitations.Stability of peri-implant tissues  appears to be one critical component for long term implant success and is influenced by many factors including surgical trauma, biological width establishment, lack of passive fit of superstructures, implant-abutment connection, etc.

The type of implant-abutment connection(IAC) has been considered to be one of the major factors affecting the peri-implant hard and soft tissues. IAC is the point of contact between the surgical and prosthetic phase and is required to provide adequate joint strength, rotational stability, prosthetic indexing and resistance to microbial penetration.

IAC are of two types- External and Internal connection. Internal connection are further diversified into numerous design in an attempt to achieve better microbial seal and joint stability which include internal hex and  internal conical.

Few studies have been conducted on comparing these two internal connections and the obtained results were variable.

The purpose of the study is to comparatively evaluate the effect of two implant abutment connection- internal hexagonal and internal conical on peri-implant soft and hard tissue after occlusal loading.

This evaluation will be done based on following parameters-

1.     Hard tissue parameter- Crestal bone loss

2.     Soft tissue parameters- Probing depth and bleeding on probing

3.     IL-1 beta levels in peri-implant sulcus fluid.

These parameters will be recorded during delivery of prosthesis (before occlusal loading-baseline) and 3, 6 and 12 months after occlusal loading. The recorded data will be tabulated and analysed and results will be drawn.

 
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