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CTRI Number  CTRI/2022/09/045185 [Registered on: 02/09/2022] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   COMPARISON OF PROSTHETIC AND CLINICAL OUTCOME OF TWO DIGITALLY MADE RESTORATIONS AN ONLAY AND A FULL CROWN 
Scientific Title of Study   “A comparative evaluation of prosthetic and clinical outcome as influenced by two digitally fabricated extracoronal restorations viz an Onlay and a full crown-a prospective, cross arch study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAROJINI BISWAL 
Designation  PG STUDENT 
Affiliation  PG student, SGT university 
Address  SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3,Chandu-Budhera, Gurgaon-Badli Road, Gurgaon(Haryana), Delhi-NCR
Gurgaon
HARYANA
122505
India 
Phone  09583076456  
Fax    
Email  aditibiswal8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhupender Yadav 
Designation  PROFESSOR 
Affiliation  professor, sgt university 
Address  SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
Gurgaon
HARYANA
122505
India 
Phone  8743019484  
Fax    
Email  drbhupinderyadav@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAROJINI BISWAL 
Designation  PG STUDENT 
Affiliation  PG student,SGT University 
Address  SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
Gurgaon
HARYANA
122505
India 
Phone  09583076456  
Fax    
Email  aditibiswal8@gmail.com  
 
Source of Monetary or Material Support  
self 
SGT University, Faculty Of Dental Sciences 
 
Primary Sponsor  
Name  SAROJINI BISWAL 
Address  SGT UNIVERSITY,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 
Type of Sponsor  Research institution and hospital 
 
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 
DrBhupender Yadav  SGT University  SGT University, Faculty Of Dental Sciences, Block-B, First Floor, Room number-3, Chandu-Budhera, Gurgaon-Badli road, Gurgaon(Haryana) Delhi-NCR
Gurgaon
HARYANA 
8743019484

drbhupinderyadav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SGTDCH&RI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K042||Pulp degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  prosthodontic and periodontic parameters  CAD CAM fabricated onlay will be compared with CAD CAM fabricated full crown present in the contralateral side of the same arch based on prosthodontic and periodontal parameters from baseline, 6 months and 12 months 
Intervention  Two types of CAD CAM prosthesis  Two types of CAD CAM fabricated prosthesis given on endodontically treated teeth in the contralateral side of the same arch from baseline ,6 months and 12 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients either male or female over the age of 18 (who can consent for themselves) in good general health.

The selected teeth needed to be in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.

Molar or premolar teeth with suspected endodontic problems that require root canal treatment.

Teeth should not be mobile and must be restorable.
 
 
ExclusionCriteria 
Details  Pregnant women, in view of requirements for radiographs (or if they could possibly be pregnant). To be confirmed by the Medical History Questionnaire.

Patients younger than 18.

Patients unable to give consent.

Teeth with probing periodontal depths greater than 5 mm.

Non-restorable teeth.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Due to advancement in bonding techniques we are expecting non significant results in cases of onlays as compared to full crowns. primary prosthodontic and periodontal parameters are recorded at baseline and same is checked again at 6 months and 12 months to compare the prosthodontic health of the restorations and their periodontal health based on respective parameters.  Due to advancement in bonding techniques we are expecting non significant results in cases of onlays as compared to full crowns compared from baseline, 6 months and 12 months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/09/2022 
Date of Study Completion (India) 28/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="2" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

TITLE-"A COMPARATIVE EVALUATION OF PROSTHETIC AND CLINICAL OUTCOME AS INFLUENCED BY TWO DIGITALLY FABRICATED EXTRACORONAL RESTORATIONS VIZ AN ONLAY AND A FULL CROWN-A PROSPECTIVE, CROSS ARCH STUDY”


AIM - To evaluate and compare the prosthetic and clinical outcome of endodontically treated mandibular posterior teeth restored using two digitally fabricated extracoronal restorations viz an onlay and a full crown- over a period of 1 year of intraoral usage.

OBJECTIVES -To evaluate the prosthetic parameters and clinical indices with respect to the mandibular posterior teeth restored with digitally fabricated emax onlay at baseline, 6 months and 12 months.

 To evaluate the prosthetic parameters and clinical indices with respect to the contralateral mandibular posterior teeth in the same arch restored with digitally fabricated emax full crown at baseline, 6 months and 12 months.

 To comparatively evaluate the prosthetic parameters and the clinical indices with respect to the mandibular posterior teeth restored with digitally fabricated emax onlay and full crown in the same arch at baseline, 6 months, and 12 months

Purpose and need of the study:-  This study mainly wants to check the success of a full crown and onlay restoration over a root canal treated posterior tooth present bilaterally on the mandibular arch based on prosthodontic and clinical parameters. we expect that the only will have better results so that we can promote minimal tooth structure damage during the preparation of the tooth and will help to keep the oral hygiene well maintained than the full crowns.


METHODOLOGY-The present study will be conducted in the Department of Prosthodontics, Crown & Bridge and Oral Implantology, Faculty of Dental Sciences, SGT University, Gurugram. The study will be a prospective cross-arch study comparing the success and survival rate of endodontically treated teeth restored using two different digitally fabricated restorations. 15 Patients requiring endodontic treatment of two teeth in the mandibular posterior region will be assessed clinically and radiographically and recruited into the study.

Group 1: Endodontically treated mandibular posterior teeth restored using digitally fabricated onlay.

Group 2: Contralateral endodontically treated mandibular posterior teeth restored using digitally fabricated full crown.

OUTCOME- EVALUTION:- Prosthodontic parameters: - ceramic and abutment fracture, marginal fit, anatomical form, proximal and occlusal contacts, color(aesthetics).

Periodontal Parameters: - bleeding on probing, plaque control record and probing pocket depth.

                                    SUMMARY & CONCLUSION:

In terms of restoring posterior teeth that have undergone endodontic treatment, the current randomized controlled clinical trial’s finding indicates that onlays are just as effective as full crowns.

The following conclusions were made in light of the split mouth prospective clinical study’s findings:

1. The Prosthetic Parameters were satisfactory for both the groups when evaluated at subsequent follow-ups.  Significant deviation was observed mainly amongst marginal integrity and marginal discoloration parameters which were more among the e.maxR onlay group.

2. Periodontal Examination revealed significant results, concluding that the periodontal parameters show better results with respect to onlay than the full crown, full crown had more periodontal damages when examined at baseline, 6 months and 1 year follow up.

                               


 
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