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CTRI Number  CTRI/2025/09/094228 [Registered on: 04/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Zygomatic and Tilted Implants in All-on-6 Maxillary Rehabilitation: A Clinical Trial 
Scientific Title of Study   Effectiveness Of Zygomatic and Tilted Implants In All-On-6 Full Arch Rehabilitation For Completely Edentulous Maxilla : A Non-Randomized Clinical Trial 
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 neha ganpat pawar 
Designation  MDS student 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Room no 106 Dept of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Room no 106 Dept of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Nagpur
MAHARASHTRA
440003
India 
Phone  7588679476  
Fax    
Email  drneha7758@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr neha ganpat pawar 
Designation  MDS student 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Room no 106 Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Room no 106 Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Nagpur
MAHARASHTRA
440003
India 
Phone  7588679476  
Fax    
Email  drneha7758@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashant K Pandilwar 
Designation  Professor and HOD 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Room No 106 Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Room No 106 Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Nagpur
MAHARASHTRA
440003
India 
Phone  7588679476  
Fax    
Email  Prashant.pandilwar@rediffmail.com  
 
Source of Monetary or Material Support  
Dept of Oral and Maxillofacial Surgery Room no 106 Government Dental College and Hospital Nagpur 
 
Primary Sponsor  
Name  Dr Neha Ganpat Pawar 
Address  Room No 106 Dept of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur 
Type of Sponsor  Other [self funding] 
 
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 Neha Ganpat Pawar  Government Dental College & Hospital Nagpur  Room No 106 Department of Oral and Maxillofacial Surgery Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar Government Dental College and Hospital Nagpur Medical Square Hanuman Nagar
Nagpur
MAHARASHTRA 		 07588679476

drneha7758@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Government Dental College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA1 or ASA2 category patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  tilted implant in atrophic edentulous maxilla   total duration of intervention is 1 year 
Intervention  zygomatic implant in atrophic edentulous maxilla  total duration of intervention is 1 year 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with Age 30-70 years of all Gender
Maxilla with Zone 1 cases according to Beddrosian classification
Patients fit for surgical procedures ASA-1 AND ASA-2
Willingness to Provide Informed Consent
Patients must be willing to comply with the study’s follow-up protocol and attend required appointments for assessment, including post-surgical visits and radiographic evaluations.

 
 
ExclusionCriteria 
Details  Blood disorders autoimmune diseases uncontrolled diabetes mellitus metabolic diseases affecting bone
Irradiation of the head or neck region
Inadequate oral hygiene performance
Smoking habit
Pregnancy or breast feeding
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Implant stability
Crestal bone level
 		 Baseline 1 week 3 months 6 months 12 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of surgery & intraoperative time
Quality of life
Ease of prosthesis fabrication
 		 Baseline 1 week 3 months 6 months 12 months
 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   18/09/2025 
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="2"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - 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 - Proposals should be directed to [drneha7758@gmail.com].

  6. For how long will this data be available start date provided 03-03-2027 and end date provided 03-10-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Edentulism compromises chewing efficiency, nutrition, appearance, and quality of life. Full-arch rehabilitation in the maxilla is often challenging due to bone resorption and sinus pneumatization. Traditionally, bone grafting was required; however, tilted and zygomatic implants now provide graftless alternatives. Tilted implants reduce cantilever length and increase prosthetic support, while zygomatic implants engage the zygomatic bone, bypassing the maxillary sinus in cases of severe posterior atrophy.

This non-randomized clinical trial compares the effectiveness of zygomatic implants versus tilted implants in an All-on-6 protocol for completely edentulous maxilla (Beddrosian Zone 1).

Primary Objectives:

  1. Compare implant stability between zygomatic and tilted implants.

  2. Assess crestal bone level changes radiographically.

Secondary Objectives:

  • Compare ease of surgery and intraoperative time.

  • Compare ease of prosthesis fabrication.

  • Assess quality of life outcomes (OHIP-14).

Study Design: Non-randomized clinical trial, two groups:

  • Group A: Zygomatic implants (n=7)

  • Group B: Tilted implants (n=7)
    Total sample: 14 patients (convenience sampling).

Inclusion Criteria: Patients aged 30–70 years, edentulous maxilla (Beddrosian Zone 1), ASA I/II, consenting and compliant.
Exclusion Criteria: Systemic contraindications (e.g., uncontrolled diabetes, blood disorders, irradiation), smoking, poor oral hygiene, pregnancy/lactation.

Intervention: All-on-6 protocol using either zygomatic or tilted posterior implants. Delayed loading (3–6 months).
Follow-up: Baseline, 1 week, 3 months, 6 months, and 12 months with radiographic and clinical assessment.

Outcome Measures:

  • Implant stability (Resonant Frequency Analysis, manual test).

  • Crestal bone level changes (OPG, CBCT).

  • Surgical ease & time (VAS, operative time).

  • Quality of life (OHIP-14).

  • Prosthesis fabrication ease (VAS).

Expected Result: Zygomatic implants may provide superior anchorage and clinical outcomes compared to tilted implants in All-on-6 rehabilitation for severely atrophic maxilla.

Ethics Approval: Obtained from IEC, GDCH Nagpur (Ref: IEC/GDCHN/35/2025, dated 03/03/2025).

 

 

 
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