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CTRI Number  CTRI/2024/11/076865 [Registered on: 18/11/2024] Trial Registered Prospectively
Last Modified On: 14/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of clinical performance of Partial Coverage and Full Coverage restorations. 
Scientific Title of Study   Comparison of Clinical Performance of the Partial Coverage Vs. Full Coverage Dental Restorations in Endodontically Treated first Molar- 1 Year 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 Pravin Kumar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dentistry, Block 2A, OPD Building. All India Institute of Medical Sciences, Jodhpur, Rajasthan Pin Code- 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Pravin Kumar 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dentistry, Block 2A, OPD Building. All India Institute of Medical Sciences, Jodhpur, Rajasthan. Pin Code- 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Karishma Pathak 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Dentistry, Block 2A, OPD Building. All India Institute of Medical Sciences, Jodhpur RAJASTHAN 342005 India

Jodhpur
RAJASTHAN
342005
India 
Phone  8619747354  
Fax    
Email  karishmap47@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Marudhar Industrial area(M.I.A), 2 phase, Basni, Pin-342005, Jodhpur, Rajasthan.India  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Jodhpur 
Address  Marudhar Industrial Area, 2nd Phase ,M.I.A. Ist Phase, Basni. Jodhpur, Rajasthan 342005 
Type of Sponsor  Government medical college 
 
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 Pravin Kumar  All India Institute of Medical Sciences, Jodhpur  Endodontic section 2A seconf floor, Department of Dentistry, Marudhar Industrial Area, 2nd Phase, M.I.A. Ist Phase Basni. Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 9818402220

kumarpr@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Endocrown   One week after endodontic treatment, patients will be recalled for Endocrown preparation. Endocrown Occlusal preparation:2mm depth orientation grooves will be marked on the tooth surface followed by reduction occlusally along the long axis of the tooth, parallel to the occlusal plane with a wheel diamond Proper bur alignment to ensure a flat surface resulting in a butt joint margin. A but joint, 90-degree supragingival circumferential band of enamel margin resting on sound enamel with a width of 1-2mm will be created. Pulp chamber preparation: To establish a continuous pulp chamber and endodontic access cavity, the pulp chamber will be prepared with cylindrical-conical coarse grit diamond point by removing the undercuts. The preparation will be done with a bur, held parallel to the long axis of the tooth to create smooth tapered walls. The pulp chamber cavity depth will be a minimum of 3mm. To improve the internal and marginal adaption of endocrowns the preparation of intracanal extensions will be avoided. Resin composite will be applied to the pulp chamber merely to remove the undercuts and seal the canal orifices. To mitigate shear stress, a circumferentially formed 1 mm wide ferrule in sound enamel will improve marginal load control and increase load distribution to the pulpal floor. Any undermined enamel shall be removed. In case a ferrule cannot be prepared, a cavosurface bevel on the functional cusp will be prepared. Following the completion of the preparation and shade selection, sectional/ complete definite impression will be made using intra-oral scanner/ Elastomeric Heavy body and Light body impression material with a one-step putty wash technique and the cast will be poured and sent further to the laboratory for the fabrication of crown. Upon receiving the crown, it will be evaluated for marginal adaptation, proximal contacts and occlusion interferences. Following this, surface pretreatment will be performed for tooth and endocrown, which then will be luted with dual-cured resin cement within 1 week of recording digital impression.The total duration will be 1 week.  
Comparator Agent  Full Coverage Crowns  One week after endodontic treatment, patients will be recalled for crown preparation. For Full- Coverage Crowns, a 1mm wide shoulder margin with 4-6-degree occlusal convergence with rounded internal angle preparation will be prepared on an endodontically treated tooth with a coarse-grit flat end diamond point, which will be further smoothed with an end cutting bur. Two plane reduction on the functional cusps with 2mm functional cusp reduction and 1.5mm non-functional cusp reduction will be done with a coarse-grit football-shaped bur. Following the completion of the preparation and shade selection, sectional/ complete definite impression will be made using intra-oral scanner. Upon receiving the crown, it will be evaluated for marginal adaptation, proximal contacts and occlusion interferences. Following this, surface pretreatment will be performed for both tooth and crown which then will be luted with dual cured resin cement. The total duration will be 1 week.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Endodontic-treated First molars
2.Absence of clinical signs and symptoms of periapical pathology
3.The presence of teeth in the proximal contact of the restoration
4.Teeth being in occlusion with antagonistic teeth
5. Patients who agreed to attend regular checks.
6. Minimum of one cusp with 3-mm thick.
7. Supragingival margins.
8. Good oral hygiene
9. Minimum of 18 years of age.
10.The absence of any systemic disease 
 
ExclusionCriteria 
Details  1. Participants who did not agree to sign the free informed consent form;
2. Tooth pain, unsatisfactory endodontic treatment, or signs of periapical lesions at the time of radiographic or clinical examination.
3. Unacceptable standard of oral hygiene or parafunctional habits
4. Severe periodontal problems
5. Pregnant women.
6. Volunteers who did not agree to follow-up visits.
7. Teeth with restorations, cracks, hypoplasia, or carious lesions on adjacent surfaces.
8. Participants undergoing orthodontic treatment.
9. Different dentists had carried out endodontic treatment.
10. The presence of any systemic disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary objective of this trial is to compare the clinical performance of post-endodontic full coverage and partial coverage restorations in restoring endodontically treated molars.   3 months, 6 months, 9 months, 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the clinical performance of two different ceramic material used in fabrication of post-endodontic final restoration.  3 months, 6 months, 9 months, 1 year 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   25/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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 altered mechanical and biochemical properties of endodontically treated teeth make it difficult for dentists to remain optimistic about their rehabilitation when compared to healthy teeth due to the volumetric loss of the hard tissues, the extent of carious lesions, access cavity for endodontic therapy and the amount of tooth structure removed for full-crown restorations. When reconstructing teeth that have had endodontic treatment, the concept of minimal intervention in dentistry to maintain and conserve healthy tooth structure is gaining popularity. Due to their ability to preserve healthy tooth structure, partial indirect adhesive restorations should be preferred over prosthetic restorations wherever possible. Thus, this study aims to evaluate the clinical outcome of partial coverage adhesive restorations when compared with full coverage crowns in restoring endodontically treated first molar.

 
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