Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.

Detailed Description
-----------------
The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.

Official Title
-----------------
Success of Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions- A Randomized Clinical Study

Conditions
-----------------
Caries

Intervention / Treatment
-----------------
* Procedure: Selective caries removal
* Procedure: Stepwise caries removal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatient in age range of 18yr-60yr Permanent mandibular posterior teeth with deep caries Caries extending to >3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph Positive response to cold test and electric pulp test Exclusion Criteria: Any general disease affecting the caries e.g. patient under head and neck radiotherapy Patients with immuno-compromised status Tooth with fracture line, cracks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized clinical study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Selective caries removal to soft dentin (one step)<br>In selective caries removal to soft dentine, after caries excavation application of liner will be done on pulpal floor. Teeth will then be filled with composite resin material. | Procedure: Selective caries removal<br>* After caries removal restoration of tooth will be performed<br>|
| Active Comparator: Stepwise caries removal (two step)<br>The stepwise caries removal is a two step procedure. The first step is similar to selective caries removal to soft dentin group. In the second step, after 6 months lesion will be re-entered to remove remaining carious tissue till firm dentin is encountered. Once all the caries is removed from floor of cavity a liner followed by final restoration with composite will be performed. | Procedure: Stepwise caries removal<br>* After caries removal restoration of tooth will be performed<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success | Clinical success will be judged by following criteria Positive response on vitality test. Absence of pain on percussion and any other signs and/or symptoms of irreversible pulpitis and pulp necrosis Criteria for failure will be Negative response on pulp vitality test. Tenderness to percussion and teeth exhibiting any clinical signs and/or symptoms of irreversible pulpitis and pulp necrosis. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Success | Absence of periapical alterations (radiolucency at furcal or periapical region). | Baseline to 12 months |