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CTRI Number  CTRI/2024/10/075449 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 03/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   TTPHIL ALL TILT, a new effective dental implant placement technique, for replacing teeth in patients with missing teeth 
Scientific Title of Study   A Prospective clinical and radiographic evaluation of TTPHIL ALL TILT treatment protocol using Bioline I implant system for partially and completely edentulous maxilla and mandible 
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 Venkat Ratna Nag P 
Designation  Director 
Affiliation  PhD student, Meenakshi Academy of Higher Education and Research 
Address  Institute for Dental Implantology
Department of Dentistry
Hyderabad
TELANGANA
500034
India 
Phone  9963511139  
Fax    
Email  venkatratnanag@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manikandhan Ramanathan 
Designation  PHD Guide 
Affiliation  PhD Guide, Meenakshi Academy of Higher Education and Research 
Address  Meenakshiammal dental college and hospital
Department of Dentistry
Chennai
TAMIL NADU
600095
India 
Phone  9963511139  
Fax    
Email  manikandhan902@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Venkat Ratna Nag P 
Designation  PHD Student 
Affiliation  PhD student, Meenakshi Academy of Higher Education and Research 
Address  Meenakshi Ammal Dental College and Hospital
Department of Dentistry
Chennai
TAMIL NADU
600095
India 
Phone  9963511139  
Fax    
Email  venkatratnanag@gmail.com  
 
Source of Monetary or Material Support  
Institute for Dental Implantology 8-2-598/A/1, GB, Uma Devraj Villa, Road no. 10, Banjara hills, Hyderabad- 500034, India 
 
Primary Sponsor  
Name  Dr Venkat Ratna Nag P 
Address  Meenakshi ammal dental college and hospital, Alapakkam Main Rd, Janaki Nagar, Maduravoyal, Chennai, Tamil Nadu 600095 
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 Venkat Ratna Nag P  Institute for Dental Implantology  Department of Prosthodontics and Implantology clinic number 7
Hyderabad
TELANGANA 		 9963511139

venkatratnanag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethical committee, Meenakshi Medical College Hospital & Research Institute   Approved 
Institutional ethical committee, Meenakshi Medical College Hospital & Research Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K082||Atrophy of edentulous alveolar ridge, (2) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  not applicable 
Intervention  TTPHIL-ALL-TILT ® treatment protocol   TTPHIL: ALL TILT technique stands for Tall, Tilted, Pin Hole, Immediate Loading protocol, which will be utilized for implant placement and restoration of the selected patients. These participants will be followed up for a period of two years at regular intervals to assess for clinical stability of implants and prosthesis and radiological measurements of bone loss over the period of study. The findings will be tabulated and subjected to statistical analysis at the end of two years. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. All cases of complete edentulism, even in resorbed maxilla and mandible. For the mandible, residual ridge crest of at least 4 mm width buccolingually and greater than 8 mm height; for the maxilla, residual ridge crest with enough width to insert a 3.5 mm–diameter implant, and greater than 8 mm height will be included in the study.
2. Immediate and delayed loading cases
3. Patients, in whom grafting procedures or zygomatic implants would be morbid or medical conditions wherein such invasive surgical procedures are contraindicated can undergo TTPHIL-ALL TILT® protocol.
 
 
ExclusionCriteria 
Details  1. Severely debilitating systemic disease.
2. Patients undergoing chemotherapy and radiotherapy.
3. Restricted mouth opening of the patient such that access of posterior regions of maxillary and mandibular arches are compromised.
Evaluation appointments will be performed at 6 months; 1 year; and 2 years for assessing implant survival. The primary outcome measure was implant and prosthesis survival based on function up to 2 years. The secondary outcome measures included marginal bone level evaluation and the incidence of biological and esthetic complications up to 2 years of function.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
An implant will be considered successful (100% survival rate) if fulfilled function of supporting full-arch restoration, stable when tested clinically, no radiolucency on radiographs, and no peri-implant inflammation or suppuration. Therefore, the implant survival rate will be determined based on Malo’s criteria. Prosthetic success: A prosthesis was considered a failure if function was compromised for any reason. Fracture of the implant or any prosthetic component will be recorded, as will be technical complications with the abutments or other prosthetic components up to 2 years of function.
 		 10 days; 2, 4,and 6 months; 1 year; and every 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome measures included marginal bone level evaluation and soft tissue assessment at 6 months, 1 and 2 years of function.
Biological complications: Peri-implantitis, peri-implant mucositis, fistula, bleeding on probing, suppuration, and numbness of the lower lip or chin will be evaluated.
Esthetic complications: esthetic complaints of patients
Marginal bone level evaluation: CBCT Scans will be performed with standardized scanning parameters at 90 kV, 10 mA, and using a field of view of 11cm × 8 cm.  		 6 months, 1 and 2 years of function. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/10/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL. To be Published after completion. 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Through Publications

  6. For how long will this data be available start date provided 01-09-2022 and end date provided 01-09-3022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
Abstract:
The scope of full mouth rehabilitation using implants have increased considerably as edentulism is prevalent in about 10 percent of world population. Increase in chewing surfaces along with elimination of cantilever for the long term functional and bio-mechanical success, irrespective of the bone type is significant from patient’s and clinician’s viewpoint. There is no single technique which can be used in all types of bone. thus TTPHIL- ALL-TILT treatment protocol attempts to fill that gap.
 
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