| 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 |
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Type of Study
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Dentistry |
| Study Design |
Non-randomized, Multiple Arm Trial |
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Public Title of Study
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COMPARISON OF PROSTHETIC AND CLINICAL OUTCOME OF TWO DIGITALLY MADE RESTORATIONS AN ONLAY AND A FULL CROWN |
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Scientific Title of Study
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“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 |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| self |
| SGT University, Faculty Of Dental Sciences |
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Primary Sponsor
|
| Name |
SAROJINI BISWAL |
| Address |
SGT UNIVERSITY,Gurgaon-Badli Road Chandu, Budhera, Gurugram, Haryana 122505 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| 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 |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGTDCH&RI |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K042||Pulp degeneration, |
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Intervention / Comparator Agent
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| 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 |
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Inclusion Criteria
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| 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.
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| 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.
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
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| 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. |
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Secondary Outcome
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| Outcome |
TimePoints |
| NIL |
NIL |
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Target Sample Size
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Total Sample Size="15" Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
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Phase of Trial
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N/A |
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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 |
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Estimated Duration of Trial
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Years="1" Months="2" Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
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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 STUDYâ€
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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