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CTRI Number  CTRI/2021/09/036356 [Registered on: 08/09/2021] Trial Registered Prospectively
Last Modified On: 26/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of stability and hard tissue changes between trabecular and laser microfused implants. 
Scientific Title of Study   ASSESSMENT OF IMPLANT STABILITY AND CRESTAL BONE LEVEL IN EARLY LOADED TRABECULAR AND LASER MICROFUSED IMPLANTS. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandra Sekhar Chadalavada 
Designation  Post graduate student 
Affiliation  Dept of periodontology, Sibar Institute of Dental Sciences,Takellapadu, Guntur 
Address  Room no - 8, Second floor, Department of periodontology, Sibar institute of dental sicences, Takellapadu, Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9704619339  
Fax    
Email  drsekhar93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramanarayana B 
Designation  Reader, Dept of periodontology 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no - 8, Second floor, Department of periodontology, Sibar institute of dental sicences, Takellapadu, Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9490144365  
Fax    
Email  dr.ramanarayana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ramanarayana B 
Designation  Reader, Dept of periodontology 
Affiliation  Sibar Institute of Dental Sciences 
Address  Room no - 8, Second floor, Department of periodontology, Sibar institute of dental sicences, Takellapadu, Guntur

Guntur
ANDHRA PRADESH
522509
India 
Phone  9490144365  
Fax    
Email  dr.ramanarayana@gmail.com  
 
Source of Monetary or Material Support  
De Tech Co LTD;Ankara, Turkey. 
 
Primary Sponsor  
Name  Chandra Sekhar Chadalavada 
Address  Room no-8, Second floor, Dept of periodontology, Sibar institute of dental sciences,Guntur,AP- 522509 
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 
Chandra Sekhar Chadalavada  Dept of periodontology  Room no-8, Second floor, Dept of periodontology, Sibar institute of dental sciences,Guntur,AP- 522509
Guntur
ANDHRA PRADESH 		 9704619339

drsekhar93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Isolated area of missing teeth 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Laser microfused implants placement  evaluate the clinical efficacy of early loaded implants by comparing the stability and hard tissue changes between trabecular implants with enhanced surface and laser microfused implants with enhanced surface roughness for duration of one year six months 
Intervention  Trabecular implant placement  evaluate the clinical efficacy of early loaded implants by comparing the stability and hard tissue changes between trabecular implants with enhanced surface and laser microfused implants with enhanced surface roughness. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients compliance to oral hygiene measures.
2.Individuals in need of tooth replacement in mandibular posterior region.
3.Apparently healthy individuals.
4.Individuals with adequate bone volume and quality(D2/D3).
5.Patients who are willing to give informed consent.


 
 
ExclusionCriteria 
Details  1.Smokers.
2.Individuals with parafunctional habits.
3.Pregnant and lactating women.
4.Presence of any pathology/condition that contraindicates implant placement. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To Assess and compare implant stability between Trabecular and Laser Microfused implants using Resonance Frequency analysis (RFA) device OSSTELL, (Sweden).
 		 Baseline, 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
To Assess and compare peri implant bone level after implant placement, in trabecular and Laser Microfused implants.  Baseline, 3 months and 6 months. 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
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)   21/09/2021 
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="1"
Months="6"
Days="3" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsekhar93@gmail.com].

  6. For how long will this data be available start date provided 05-08-2021 and end date provided 05-02-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Endosseous dental implants have become a predictable method of replacing missing teeth to enhance the patient’s quality of life. Formation of direct bone to implant contact is the main success criteria in implant dentistry. Porous surface should enhance integration following bone grow into the pores. Porous surface coating should enhance integration, by allowing bone growth inside the pores; however, the number and size of the pores that can be obtained on the surface of the implant determine the quality and quantity of the bone growth. Histological studies showed that while a pore size of    Ì´ 100 µm is adequate for bone ingrowth , osteon formation inside a porous material needs Ì´ 150 µm pores , while   pores   greater   than Ì´   300 µm are required to support vascularised bone ingrowth .


The porosity of Trabecular implant not only significantly increases the surface available for bone formation, but also allows angiogenesis and bone formation inside the pores : the average pore size of Trabecular implant is Ì´ 550 µm, adequate for blood vessel formation and osseoincorporation . The term osseoincorporation indicates the combination of osseointegration/bone on-growth (bone to implant contact, BIC) and bone ingrowth within the porous material. Resonance Frequency Analysis (RFA) is proven to be an accurate method to assess implant stability. In the present study, Osstell, Sweden ISQ, that utilises RFA technology was used to determine implant stability. RFA consists of a transducer connected to an implant, which is excited over a range of frequencies. RFA causes the implant to vibrate while at the same time, analyses the implant motion to provide information as an implant stability quotient (ISQ) on a scale from 1–100. 
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