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CTRI Number  CTRI/2025/03/081697 [Registered on: 05/03/2025] Trial Registered Prospectively
Last Modified On: 02/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Effect of differently polished Zirconia Crowns on Gingival Health]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare gingival health around two types of implant crowns 
Scientific Title of Study   A one-year Split-Mouth Randomized Controlled Trial to evaluate peri-implant mucosal health after cementation of Ultra-polished Zirconia crown compared with Conventionally polished Zirconia crown using periodontal indices (BOP, PD, PI) and Gingival biomarkers i.e. TNF-α and IL-1β  
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 Vaibhav Shegaonkar 
Designation  Junior Resident 
Affiliation  CDER, AIIMS, New Delhi 
Address  Department of Prosthodontics, 2nd Floor, Centre for Dental Education and Research, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  8080761931  
Fax    
Email  vaibhavshegaonkar211@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Veena Jain 
Designation  Professor and Head 
Affiliation  CDER, AIIMS, New Delhi 
Address  Department of Prosthodontics, 2nd Floor, Centre for Dental Education and Research, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868187441  
Fax    
Email  jainveena1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Veena Jain 
Designation  Professor and Head 
Affiliation  CDER, AIIMS, New Delhi 
Address  Department of Prosthodontics, 2nd Floor, Centre for Dental Education and Research, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  9868187441  
Fax    
Email  jainveena1@gmail.com  
 
Source of Monetary or Material Support  
Dr Vaibhav Shegaonkar 2nd Floor Department of Prosthodontics Centre for Dental Education and Research All India Institute of Medical Sciences Sri Aurobindo Marg Ansari Nagar New Delhi 110029 Delhi India 
 
Primary Sponsor  
Name  Dr Vaibhav Shegaonkar 
Address  2nd Floor Department of Prosthodontics Centre for Dental Education and Research All India Institute of Medical Sciences Sri Aurobindo Marg Ansari Nagar East New Delhi 110029 Delhi India  
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 Vaibhav Shegaonkar  Center for Dental Education and Research  2nd Floor Department of Prosthodontics
New Delhi
DELHI 		 8080761931

vaibhavshegaonkar211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee. AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of Conventionally Polished Implant Crowns on Gingival Health  Zirconia crowns will be polished using the zirconia polishing kit Conventional polishing These crowns will cemented and its effect on gingival health will be measured using various gingival health indices and cytokine markers 
Intervention  Effect of Ultra Polished Zirconia Implant Crowns on Gingival Health  Zirconia crowns will be polished using the zirconia polishing kit Conventional polishing After conventional polishing zirconia crowns will be additionally polished using the diamond polishing paste ultra polishing to provide a smoother surface finish These crowns will cemented and its effect on gingival health will be measured using various gingival health indices and cytokine markers 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients requiring placement of implants for replacement of bilateral missing tooth site bound by natural teeth.
2.Adequate amount of available bone for placement of dental implant.
3.Well healed partially edentulous site
4.Good oral hygiene and periodontal status of remaining dentition.
5.Available for follow up.
6.With positive informed consent.
7.Both the edentulous areas having antagonist teeth.
 
 
ExclusionCriteria 
Details  1 Bone metabolic disorders affecting surrounding bone health
2 Vertical soft tissue thickness of less than 2 mm in the implant site
3 History of radiotherapy in head and neck region
4 Current habit of smoking or alcohol or drug abuse
5 Systemic conditions and auto immune disorders that might affect the integrity of implant or connective tissue health surrounding the implant
6 Blood disorders such as Haemophilia sickle cell anaemia thrombocytopenia
7 Signs of infection in the prospective implant site or retained root
8 Pregnancy or lactating mothers at the time of enrolment
9 Parafunctional habits such as bruxism and clenching
10 Local limitations such as inadequate inter ridge distance or mesiodistal space
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1 To compare the gingival health between the study arms at time 1 month after cementation using Pocket Depth Plaque Index and using biomarkers TNF Aplha and IL 1 Beta
2.To compare the gingival health between the study arms at time 1 year after cementation using Pocket depth Plaque Index and using biomarkers TNF Aplha and IL 1 Beta
 		 Baseline 4 weeks 52 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess gingival health using BOP, PD, PI and using biomarker TNF- α and IL-1β just before cementation(T0), immediately1 month after cementation(T1) and at 1 year after cementation (T2) in the intervention arm of Ultra polished Zirconia crown
2.To assess gingival health using BOP, PD, PI and using biomarker TNF- α and IL-1β just before cementation(T0), immediately1 month after cementation(T1) and at 1 year after cementation (T2) in the control arm of conventionally polished Zirconia crown
 		 1 month and 1 year 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 2 
Date of First Enrollment (India)   13/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  13/03/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The roughness of the Crowns surface might affect the gingival health around Implant. Till Date conventionally polished Zirconia Crowns are used are prothesis over implants. Ultra polishing of Zirconia has been proposed to produce smoother surface. The aim of the Study is to evaluate and compare the effect of Conventionally polished and Ultra Polished Zirconia implant crowns on the gingival health. 
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