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CTRI Number  CTRI/2021/12/038506 [Registered on: 08/12/2021] Trial Registered Prospectively
Last Modified On: 15/03/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Screw retained maxillary anterior crowns on implants  
Scientific Title of Study   “ EVALUATION OF BIOLOGICAL, MECHANICAL AND PATIENT REPORTED PARAMETERS ASSOCIATED WITH ANGULATED SCREW CHANNEL ABUTMENTS AND MULTI UNIT ABUTMENTS FOR FABRICATION OF SCREW RETAINED IMPLANT CROWNS IN ANTERIOR ESTHETIC ZONE – AN IN VIVO STUDY.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Niyati Varshney 
Designation  Post Graduate student 
Affiliation  Subharti Dental College and Hospital Swami Vivekanand Subharti University 
Address  Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India 
Phone  7895306191  
Fax    
Email  niyati_manu1994@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Chandan Kumar Kusum 
Designation  Associate Professor 
Affiliation  Subharti Dental College and Hospital Swami Vivekanand Subharti University 
Address  Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India 
Phone  9627600077  
Fax    
Email  ckkusum@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Niyati Varshney 
Designation  Post Graduate student 
Affiliation  Subharti Dental College and Hospital Swami Vivekanand Subharti University 
Address  Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Department of Prosthodontics and Crowns and Bridges Subharti Dental College and Hospital Swami Vivekanand Subharti University Meerut Uttar Pradesh
Meerut
UTTAR PRADESH
250005
India 
Phone  7895306191  
Fax    
Email  niyati_manu1994@yahoo.co.in  
 
Source of Monetary or Material Support  
Vinesh Kumar Varshney House no 786 sector 11 Vasundhara Ghaziabad Uttar Pradesh 201012 
 
Primary Sponsor  
Name  Dynamic Abutment Solutions 
Address  Geoda Medical SL Cl Virginia Woolf 17 25005 Lleida Spain 
Type of Sponsor  Other [company] 
 
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 
Niyati Varshney  Subharti Dental College  Room no 6 Department of Prosthodontics and Crown & Bridge Swami Vivekanand Subharti University Subharti Puram NH-58 Delhi Haridwar Meerut Bypass Road Meerut Uttar Pradesh 250005
Meerut
UTTAR PRADESH 
7895306191

niyati_manu1994@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
university ethics committee (medical)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  maxillary anterior edentulism 
Patients  (1) ICD-10 Condition: K084||Partial loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Angulated Screw Channel abutment  Angulated Screw Channel technology changes the screw accessibility from palatal direction, rather than the prosthetic screw direction.  
Comparator Agent  Multi unit abutments  Multi unit abutments brings the screw access hole palatally by changing the prosthetic screw direction. Also, these definitive MUAs enable better hemidesmosomal adherence between the soft tissue and titanium and therefore might reduce bone resorption around the implants. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patient willing for the procedure (the study is explained, including the procedure and follow up for evaluation)
2) Patient that has good oral hygiene and periodontal health (patients that can follow up for evaluation)
3) Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration
4) Implant site free from infection
 
 
ExclusionCriteria 
Details  1. Medical and general contraindications for the surgical procedures
2. Presence of active and uncontrolled periodontal disease
3. History of local radiotherapy to the head and neck region.
4. Systemic diseases (Uncontrolled diabetes, recent MI, valvular prosthesis surgery, bleeding disorders, acute renal failure, immunosuppression).
5. Patients in intravenous bisphosphonate.
6. Psychiatric illness
7. Chronic heavy smokers
8. History of head and neck irradiation in the last 6 months.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Angulated screw channel abutment and multi unit abutment can alter angulation of screw hole and used in anterior screw retained prosthesis.  at baseline prosthesis delivery
6 months
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
biological, mechanical and patient reported parameters  at baseline
6 months
1 year 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2021 
Date of Study Completion (India) 30/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
in peer review 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The present study was conducted in the Department of Prosthodontics and Crown & Bridge, Subharti Dental College and Hospital, Meerut is to evaluate biological, mechanical and patient reported parameters associated with Angulated Screw Channel abutments and Multi unit abutments for fabrication of screw retained implant crowns in anterior esthetic zone. For the study 20 patients were selected who needed implants in maxillary anterior region. The implants were placed either crestal or subcrestal position to accommodate the angulated abutments (Angulated Screw Channel and Multi unit abutments) in a way that it lie within the prosthetic envelop. Depending on the group assigned, a screw retained crown was made either on ASC abutment or MU abutment. All the parameters were evaluated at the time of crown placement and 12 months after crown placement. The data then was statistically evaluated and compared. In the present study, implant survival was found 100% in both groups. MBL decreased significantly from baseline to 1-year follow-up in both groups. MBL in the MU group was slightly lower than in the ASC group but this difference was not statistically significant. Also, no statistically significant difference was found in the modified plaque index, modified sulcus index, and gingival index at baseline and 1-year follow-up values in both groups.

The RTL value was significantly lower (p<0.003) in the ASC group than MU group at baseline, however, no statistically significant difference in RTL and screw loosening was found at 1-year follow-up between both the groups. There was no statistically significant difference in patient-reported parameters. Limitations of this study were the small sample size and short-term follow-up period. The high cost and limited documented clinical success rate of these abutments as single-unit implant restoration have restricted their application in day-to-day practice. Thus, prospective studies with long-term follow-ups and larger sample sizes are required to understand the possible biological, mechanical and patient-reported parameters, and draw concrete decisions about the superiority of either of the abutments. Within the limitations of this study, it can be stated that the ASC and MU abutments with anti-rotation feature can be used as an effective alternative for screw retained restorations in cases of non-axially loaded implant with excellent clinical performance after 1 year of function.

 
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