| CTRI Number |
CTRI/2024/06/068331 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the clinical success of teeth prepared using a new preparation technique and rehabilitated with zirconia crown or metal ceramic crown fabricated using computer aided design and manufacturing technology. |
|
Scientific Title of Study
|
Comparison of clinical outcomes of tooth prepared using biologically oriented preparation technique and restored with CAD CAM monolithic zirconia or metal-ceramic crowns: 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. Ida Esther Celina |
| Designation |
Postgraduate Student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
E-Block, 3rd Floor,
Room No.7,
Department of Prosthodontics and Implantology. Rajiv Gandhi Salai (OMR),
Kancheepuram TAMIL NADU 603103 India |
| Phone |
|
| Fax |
|
| Email |
idaesthercelina@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Eazhil R |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Prosthodontics, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9841332224 |
| Fax |
|
| Email |
eazhil235@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr R Sridharan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Department of Prosthodontics, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9444170808 |
| Fax |
|
| Email |
drmottu@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute, Rajiv Gandhi Salai (OMR), Kancheepuram District, Kelambakkam - 603103. |
|
|
Primary Sponsor
|
| Name |
Dr J Ida Esther Celina |
| Address |
Chettinad Dental College and Research Institute,
Rajiv Gandhi Salai (OMR),
E-Block, 3rd Floor,
Room No.7,
Department of Prosthodontics and Implantology,
Kelambakkam,
Kancheepuram District,
Pin - 603103. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Ida Esther Celina |
Chettinad Dental College and Research Institute |
Department of Prosthodontics,
E - Block,
3rd Floor, Room No 7,
Chettinad Health City,
Rajiv Gandhi Salai(OMR),
Kelambakkam - 603103 Kancheepuram TAMIL NADU |
7358518682
prosthorctcdcri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee - Chettinad Dental College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K038||Other specified diseases of hard tissues of teeth, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tooth prepared with Biologically Oriented Preparation Technique (BOPT) and restored with CAD-CAM metal-ceramic crown |
A single tooth that needs restoration with a crown after root canal treatment will be prepared using the BOPT technique and immediately restored with a temporary crown for 4 weeks. After 4 weeks they will receive a permanent CAD-CAM metal-ceramic crown. |
| Intervention |
Tooth prepared with Biologically Oriented Preparation Technique (BOPT) and restored with CAD-CAM Monolithic Zirconia Crown |
A single tooth that needs restoration with a crown after root canal treatment will be prepared using the BOPT technique and immediately restored with a temporary crown for 4 weeks. After 4 weeks they will receive a permanent CAD-CAM monolithic zirconia crown. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1)18-45 years
2)Both males and females
3)Periodontally healthy molar or premolar teeth requiring full crowns after endodontic treatment
4)Unprepared or minimally restored contralateral tooth
5)Adequate crown-root ratio
6)Stable occlusion with a natural dentition in the opposing arch |
|
| ExclusionCriteria |
| Details |
1)Teeth with pre-existing periodontal diseases (probing depth more than 3 mm)
2)Patients with Bruxism
3)Poor oral hygiene
4)The tooth with a short/malformed clinical crown
5)Teeth requiring post and core
6)Uncontrolled systemic diseases
7)Smoking and tobacco use
8)Pregnant and lactating mothers
9)Patients taking drugs that interfere with bone or soft tissue healing eg: Bisphosphonates and corticosteroids.
|
|
|
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.Total technical complications between monolithic zirconia and metal ceramic crown
Sample size was calculated using the total technical outcomes of metal ceramic crown (27.1%) and zirconia crown (5.4%) obtained from a previous study, 80% power, 5% alpha error. The total sample size was 35 per group which was increased to 40 per group (total 80 patients) to adjust for 10% dropout. |
Baseline, 6 months, 1 and 3 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Survival analysis – between monolithic zirconia and metal-ceramic crown.
2. Comparison of the Plaque index (Rustogi Modification of Navy Plaque Index) and the Bleeding index (Ainamo and Bay). |
Baseline, 6 months, 1 and 3 year |
|
|
Target Sample Size
|
Total Sample Size="78" Sample Size from India="78"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prosthorctcdcri@gmail.com].
- For how long will this data be available start date provided 01-12-2027 and end date provided 31-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Objectives: The purpose of this study is to compare the biological and mechanical outcomes of teeth prepared using biologically oriented preparation technique (BOPT) and restored with CAD-CAM zirconia or CAD-CAM Metal-ceramic crowns Material and Methods: The study will be conducted as a single-center randomized clinical trial with two parallel arms. Ethical clearance will be obtained and the trial will be conducted according to the Declaration of Helsinki. Patients visiting the outpatient department of Prosthodontics will be enrolled according to the inclusion and exclusion criteria after obtaining informed/written consent. A total of 78 patients requiring single crowns in endodontically treated premolar or molar teeth will be randomized (1:1 ratio) to receive CAD-CAM Zirconia (ZIR Group) or CAD-CAM Metal Ceramic Crown (MCC Group). The tooth will be prepared according to the BOPT protocol and immediately restored with a temporary (provisional) crown. After 4 weeks the impressions for the permanent crowns will be made. The permanent CAD-CAM zirconia or CAD-CAM metal-ceramic crowns will be fabricated in the laboratory according to the manufacturer’s instructions. The permanent crowns will be cemented with glass ionomer cement. The outcome assessment will be done by an experienced clinician who will be blinded. The clinical performance of the crowns will be assessed using revised FDI criteria for direct and indirect restorations (2023). The definitive crowns that belong to the “sufficient category†(clinically excellent, clinically good, clinically satisfactory ) in the revised FDI criteria (2023) will only be cemented others will be discarded and remade. Follow-up assessment will be done 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years. Technical complications will be compared between the two groups and survival rate will be assessed using the Kaplan-Meir estimate after 1 and 3 years. The probing pocket depth, clinical attachment level, plaque index (Rustogi Modification of Navy Plaque Index 1992), and bleeding on probing (Ainamo and Bay) will be measured 1 week after the cementation of permanent crowns (baseline), at 6 months, 1 year, 2 years, and 3 years and compared with the unrestored or minimally restored contralateral control tooth. |