Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations

Study Overview
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Brief Summary
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PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial

Official Title
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Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial

Conditions
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Hypersensitivity Dentin

Intervention / Treatment
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* Procedure: Immediate dentin sealing protocol
* Procedure: Delayed dentin sealing protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extensive carious lesions indicated for indirect restorations Lower first molars Age of patients range is 18 -50 years Patients have not received antibiotic therapy for 1 month before sampling Males or Females (Both genders) Patients with Good oral hygiene Co-operative patients approving the trial Exclusion Criteria: Pregnancy Systemic disease or severe medical Patients having complications as: Periodontal problems Mobile teeth, arrest caries and non-vital teeth Heavy smoking patients Xerostomia Lack of compliance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed dentine sealing<br> | Procedure: Delayed dentin sealing protocol<br>* Sealing the dentin just prior to cementation<br>|
| Experimental: Immediate dentin sealing<br> | Procedure: Immediate dentin sealing protocol<br>* Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative hypersensitivity at baseline | The post-operative hypersensitivity assessment will be performed at baseline , using visual analogue scale (VAS) for both intervention and control group . The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity | 10 minutes | 
| Post-operative hypersensitivity one week after temporization | The post-operative hypersensitivity will be assessed one week after temporization for both intervention and control group using the visual analogue scale VAS .The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity , the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity | 1 week | 
| Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration | The post-operative hypersensitivity will be assessed using visual analogue scale VAS 1 week after cementation of the indirect tooth coloured restoration. The visual analogue scale is a scale numbered from zero to 10 , where as the range from zero to three resembles from no to very mild sensitivity, the range from four to seven resembles moderate sensitivity and from eight to ten resembles severe sensitivity | 1 week |