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

Inflammatory Biomarker Based Substantiation of Evidence for Performance of Vital Pulp Therapy as Potential Alternative to Endodontic Treatment using Quantitative light-induced Fluorescence Guided Caries Removal for Management of Symptomatic Carious Mature Teeth (Extremely Deep/Deep Carious Lesion)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049408
Enrollment
120
Registered
2023-02-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K029- Dental caries, unspecified

Interventions

Intervention1: QLF Guided Vital pulp Therapy: In the intervention group. After caries removal with burs, prepared cavity will be scanned with Quantitative light induced fluorescence (QLF) device. The

Sponsors

Maulana Azad Institute of Dental Sciences, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

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 ( 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

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.

Design outcomes

Primary

MeasureTime frame
Clinical and Radiographic success of Vital pulp Treatment at minimum one year follow up Post operative pain correlation between Inflammatory markers and pre operative diagnosis Timepoint: 12 months

Secondary

MeasureTime frame
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

Countries

India

Contacts

Public ContactDr Sudha Yadav

Maulana Azad Institute of Dental Sciences

ruchika.roongta@gmail.com9582948894

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026