Inflammatory Biomarker Based validation of Evidence for Vital Pulp Therapy as Alternative to Root Canal Treatment for advanced Dental Caries

Phase 2

Recruitment & Eligibility

Inclusion Criteria

Clinical inclusion criteria:

The age of the patient should be 18 or above

Patient should have non-contributory medical history

Symptomatic permanent mature posterior tooth with deep or extremely deep Class I/II caries with symptoms indicative of irreversible pulpitis

History of Moderate to severe pain

History of spontaneous pain and/or nocturnal pain which aggravates on lying down.

Patient reporting with spontaneous pain and/or with sharp and lingering pain upon

cold testing using Endo-Ice and early exaggerated response with electric pulp testing.

A restorable tooth with probing pocket depth ( <3mm) and mobility within normal limits.

Complete caries removal will result in pulpal exposure.

Pulpal bleeding can be arrested with 2.5-3% NaOCl irrigation within 10 minutes after

inflamed pulp amputation.

Radiological inclusion criteria:

Deep or Extremely deep caries

Absence of periapical or furcation changes in the radiograph.

Exclusion Criteria

Clinical exclusion criteria:

Tooth having unexposed pulp after complete caries removal.

Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.

Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.

Tooth showing negative response to cold testing or presence of sinus tract or swelling.

Radiological exclusion criteria:

Prominent radiolucency at the furcation or periapical regions

Presence of apical resorption

Presence of internal or pathologic external root resorption, calcification, or pulp canal

obliteration.

Primary Outcome Measures

Name	Time	Method
Clinical and Radiographic success of Vital pulp Treatment at minimum one year follow up <br/ ><br> <br/ ><br>Post operative pain <br/ ><br>correlation between Inflammatory markers and pre operative diagnosis <br/ ><br>Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
Association between level of inflammatory mediators in Pulpal Blood and treatment outcomeTimepoint: 12 months;Correlation between level of inflammatory mediators in pulpal blood and preoperative diagnosisTimepoint: 12 months;Effect of Vital pulp treatment on Oral Health Related Quality of LifeTimepoint: 12 months;Post operative pain assessed using visual analog scaleTimepoint: i,3,7,14 days