A Study to check Result of Treating Painful Decayed Teeth using Two Different Techniques of Pulp Removal.

Phase 2

Completed

• Conditions: Pain, unspecified,

• Registration Number: CTRI/2019/12/022559
• Lead Sponsor: Maulana Azad Institute Of Dental Sciences

Brief Summary

This single blind clinical trial will be conducted on the patients with signs and symptoms of irreversible pulpitis due to cariously exposed molar teeth. After inclusion and exclusion criteria, 50 patients will be enrolled in the study which will be randomized to two groups of 25 each (Group 1 and Group 2). in Group 1, Partial Pulpotomy will be performed after complete excavation of caries and hemostasis using NAOCl followed by 2-3mm removal of coronal pulp. In group 2, Full pulpotomy will be performed after complete excavation of caries and hemostasis using NAOCl followed by complete removal of coronal pulp.the teeth will then be restored with Biodentine.After 14 days, some amount of biodentine will be trimmed and replaced with composite followed by the post operative radiograph.Patients will be followed up for after 3 months and 6 months to evaluate clinical and radiological success of the pulpotomized teeth. The outcome assessment of Partial and Full Pulpotomy will be analysed using appropriate statistical tests.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Last Update Posted: 2022-12-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical inclusion criteria 1.The patient should be more 18 years old 2.Patient should have non-contributory Medical history 3.Tooth with deep Class I caries presenting with signs and symptoms indicative of irreversible pulpitis.
• 4.History of spontaneous pain and/or nocturnal pain which aggravates on lying down.
• 5.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.
• 6.A restorable tooth with probing pocket depth(<3mm) and mobility within normal limits.
• 7.Complete caries removal will result in pulpal exposure.
• 8.Bleeding from the pulp exposure site stops with 2.5-3% NaOCl irrigation within 10 minutes.
• Radiological inclusion criteria 1.Extremely deep caries (penetrating the entire thickness of the dentine without a radiopaque zone separating the lesion from the pulp) 2.Absence of periapical or furcation changes in the radiograph.

Exclusion Criteria

• 1.Tooth having unexposed pulp after complete caries removal.
• 2.Tooth exhibiting uncontrolled pulpal haemorrhage during the procedure lasting more than 10 minutes.
• 3.Exposed pulp tissue appearing necrotic, judged by absence of bleeding or presence of pale necrotic pulp tissue.
• Presence of internal or pathologic external root resorption, calcification or pulp canal obliteration.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of spontaneous pain and pain during chewing,Lack of swelling and sinus tract, fistula	pre operative, post operative, 2 weeks, 3 months and 6 months of procedure

Secondary Outcome Measures

Name	Time	Method
No periapical or furcation changes and Absence of internal and/or external root resorption in the radiograph

Trial Locations

Locations (1)

Maulana Azad Institute Of Dental Sciences; 🇮🇳 Central, DELHI, India

Maulana Azad Institute Of Dental Sciences

🇮🇳Central, DELHI, India

Dr Ashima Jassal

Principal investigator

9069610885

ashimajassal012@gmail.com