FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080806 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A RANDOMIZED CONTROLLED TRIAL TO COMPARE THE SUCCESS OF OVERLAYS AND CROWNS AS RESTORATIONS AFTER ROOT CANAL THERAPY. 
Scientific Title of Study   A COMPARATIVE ASSESSMENT OF THE SUCCESS RATE OF BONDED LITHIUM DISILICATE CERAMIC OVERLAYS AND CONVENTIONAL FULL COVERAGE CROWNS AS POST ENDODONTIC RESTORATIONS - A 1 YEAR RANDOMIZED CONTROLLED 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  VARADA M 
Designation  MDS STUDENT 
Affiliation  EDUCARE INSTITUTE OF DENTAL SCIENCES, AFFILIATED TO KERALA UNIVERSITY OF HEALTH SCIENCES, RECOGNISED BY DENTAL COUNCIL OF INDIA AND DEPARTMENT OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA, NAAC ACCREDITED  
Address  DEPARTMENT OF PROSTHODONTICS AND CROWN & BRIDGE FIRST FLOOR CLINICAL BLOCK EDUCARE INSTITUTE OF DENTAL SCIENCES KILIYAMANNIL CAMPUS CHATTIPARAMBA MALAPPURAM DISTRICT

Malappuram
KERALA
676504
India 
Phone  8075084534  
Fax    
Email  drvaradam96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MENON PRASAD RAJAGOPAL 
Designation  PROFESSOR AND HEAD OF THE DEPARTMENT OF PROSTHODONTICS 
Affiliation  EDUCARE INSTITUTE OF DENTAL SCIENCES, AFFILIATED TO KERALA UNIVERSITY OF HEALTH SCIENCES, RECOGNISED BY DENTAL COUNCIL OF INDIA AND DEPARTMENT OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA, NAAC ACCREDITED  
Address  DEPARTMENT OF PROSTHODONTICS AND CROWN & BRIDGE FIRST FLOOR CLINICAL BLOCK EDUCARE INSTITUTE OF DENTAL SCIENCES KILIYAMANNIL CAMPUS CHATTIPARAMBA MALAPPURAM DISTRICT

Malappuram
KERALA
676504
India 
Phone  9447262314  
Fax    
Email  menonprasad75@gmail.com  
 
Details of Contact Person
Public Query  
Name  VARADA M 
Designation  MDS STUDENT 
Affiliation  EDUCARE INSTITUTE OF DENTAL SCIENCES, AFFILIATED TO KERALA UNIVERSITY OF HEALTH SCIENCES, RECOGNISED BY DENTAL COUNCIL OF INDIA AND DEPARTMENT OF HEALTH AND FAMILY WELFARE, GOVERNMENT OF INDIA, NAAC ACCREDITED  
Address  DEPARTMENT OF PROSTHODONTICS AND CROWN & BRIDGE FIRST FLOOR CLINICAL BLOCK EDUCARE INSTITUTE OF DENTAL SCIENCES KILIYAMANNIL CAMPUS CHATTIPARAMBA MALAPPURAM DISTRICT

Malappuram
KERALA
676504
India 
Phone  8075084534  
Fax    
Email  drvaradam96@gmail.com  
 
Source of Monetary or Material Support  
EDUCARE INSTITUTE OF DENTAL SCIENCES KILIYAMANNIL CAMPUS CHATTIPARAMBA MALAPPURAM DISTRICT KERALA 676504 
 
Primary Sponsor  
Name  VARADA M 
Address  MANAKKAL HOUSE ARIYALLUR POST MALAPPURAM DISTRICT 676312 
Type of Sponsor  Other [SELF] 
 
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 
VARADA M  EDUCARE INSTITUTE OF DENTAL SCIENCES   DEPARTMENT OF PROSTHODONTICS AND CROWN & BRIDGE FIRST FLOOR CLINICAL BLOCK EDUCARE INSTITUTE OF DENTAL SCIENCES KILIYAMANNIL CAMPUS CHATTIPARAMBA MALAPPURAM DISTRICT - 676504
Malappuram
KERALA 		 8075084534

drvaradam96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  HEALTHY HUMANS  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 1: Experimental group —This group will comprise of patients with bonded lithium disilicate ceramic overlays (35 overlays). Group 2: Control group—This group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation.  The study population will be selected from the out patients (OP) visiting the Department of Prosthodontics and Crown & Bridge and the Department of Conservative Dentistry and Endodontics, Educare Institute of Dental Sciences, Malappuram. The study groups will be selected randomly based on the inclusion and exclusion criteria. Prospective patients fulfilling the inclusion and exclusion criteria will be screened clinically after informing them about the study and after gaining informed consent from them regarding the same. They will then be randomly allocated into 2 groups, experimental group and control group by tossing a coin method of randomization. The calculated total sample size is 70, with each group consisting of 35 samples . Group 1: Experimental group —This group will comprise of patients with bonded lithium disilicate ceramic overlays (35 overlays).Group 2: Control group — This group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation. 
Comparator Agent  Group 2: Control group—This group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation.  The study population will be selected from the out patients (OP) visiting the Department of Prosthodontics and Crown & Bridge and the Department of Conservative Dentistry and Endodontics, Educare Institute of Dental Sciences, Malappuram. The study groups will be selected randomly based on the inclusion and exclusion criteria. Prospective patients fulfilling the inclusion and exclusion criteria will be screened clinically after informing them about the study and after gaining informed consent from them regarding the same. They will then be randomly allocated into 2 groups, experimental group and control group by tossing a coin method of randomization. The calculated total sample size is 70, with each group consisting of 35 samples . Group 1: Experimental group —This group will comprise of patients with bonded lithium disilicate ceramic overlays (35 overlays).Group 2: Control group — This group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Healthy patients in 20-60 age group having most of the dentition. Patients having at least 3 walls of intact tooth structure after endodontic treatment. Endodontically treated teeth with adequate bone support. Patients with good oral hygiene and plaque control. Patients with healthy gingival and periodontal status, having probing depth less than 4 mm in all teeth. Patients with class 1 occlusion. 
 
ExclusionCriteria 
Details  Patients with bruxism and other parafunctional habits. Patients having loss of teeth in quadrant opposing the restoration. Patients with systemic diseases which might hinder the outcome of the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical evaluation will be performed using USPHS Criteria for anatomic form, marginal adaptation, colour match, marginal discolouration, caries and surface roughness.  Clinical evaluation will be performed using USPHS Criteria for anatomic form, marginal adaptation, colour match, marginal discolouration, caries and surface roughness at baseline, 6 months, 12 months.  
 
Secondary Outcome  
Outcome  TimePoints 
Clinical evaluation of certain parameters such as mode of fracture & debonding of restoration will be carried out.  Clinical evaluation of certain parameters such as mode of fracture & debonding of restoration will be carried out at baseline, 6 months, 12 months. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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   N/A 
Date of First Enrollment (India)   23/02/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [c].

  6. For how long will this data be available start date provided 01-01-0001 and end date provided 01-01-0001?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   BACKGROUND AND RATIONALE 
The success of endodontic treatment depends not only on the endodontic procedure but also on the appropriate and timely coronal restoration of the tooth. Tooth fracture is one of the potential causes of endodontic failure. Full coverage crowns are the gold standard post endodontic restoration of choice from many years.

Full coverage crowns are dental restorations that completely cover the clinical crown of a natural tooth. They are known to be durable which increases the patient satisfaction with these restorations. Since the posterior teeth are exposed to heavy masticatory loading forces, restorations with total occlusal coverage are highly recommended in endodontically treated teeth of the area. However, the use of full coverage restorations leads to extensive tooth preparation which goes against the principle of tooth conservation.

Recently a huge growth is seen in the field of adhesive dentistry which has led to the growing trends of minimally invasive partial coverage restorations like overlays. Overlays provide major advantages like conservation of peri radicular dentin and minimal tooth preparation. Lithium disilicate is one of the most versatile metal free restorative materials, which has high esthetic potential, good mechanical properties and favorable bonding strength to dental tissues. Hence its chosen as the material of choice for the overlays.

There are several clinical studies evaluating the performance and survival of inlays, onlays, and crowns, but as per the author’s knowledge very limited studies have been found to be conducted regarding the success rate of overlays as post endodontic restorations, and regarding its comparison with conventional full coverage crowns. So the purpose of this study is to compare the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations over a period of one year. Further long term studies may be required to gain a proper understanding about these restorations; nevertheless, this study is aimed to help us gain a better understanding about this field and in the formulation of a definite clinical protocol.

RESEARCH QUESTION
Are ceramic bonded overlays as successful as conventional full coverage crowns in post endodontically treated teeth ?

AIM
To evaluate the success rate of bonded lithium disilicate ceramic overlays over a 1 year period.

OBJECTIVES
To evaluate the success rate of bonded lithium disilicate ceramic overlays. To evaluate the success rate of conventional full coverage crowns. To compare the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations.

NULL  HYPOTHESIS
There is no difference in the success rate of bonded lithium disilicate ceramic overlays and conventional full coverage crowns as post endodontic restorations.

STUDY DESIGN
Experimental study, randomized controlled trial.

SAMPLING METHOD
Simple random sampling method by tossing a coin method of randomization.

PROCEDURE
The study population will be selected from the out patients visiting the department of prosthodontics and department of endodontics, Educare institute of dental sciences, Malappuram. The study group will be selected randomly based on the inclusion and exclusion criteria. Prospective patients fulfilling the criteria will be screened clinically after informing them about the study and after gaining informed consent from them. They will then be randomly allocated into two groups, experimental and control group by tossing a coin method of randomization. The calculated sample size is 70, with each group consisting of 35 samples. Group 1 or experimental group will comprise of patients with bonded lithium disilicate ceramic overlays (35 overlays) and group 2 or control group will comprise of patients with PFM full coverage crowns (35 full coverage crowns). Tooth preparations will be done following the principles of tooth preparation.

FOLLOW UP CRITERIA
Clinical evaluation will be performed at every 6 months using modified united states public health service (USPHS) criteria. Along with clinical evaluation of certain parameters such as mode of fracture and debonding of restoration will be carried out.

ETHICAL CONSIDERATION
Patients will be briefly informed about the procedure prior to the study. Patients will be given written consent form in English and Malayalam regarding the procedures. Written consent in English and Malayalam will be taken from the patient prior to the procedure. No special charges will be levied from the patient. No reward or compensation will be granted to anyone particularly in this study.
 
Close