Pulpotomy in mature permanent tooth using various biomaterials

Not yet recruiting

• Conditions: Pulpitis,

• Registration Number: CTRI/2023/06/053989
• Lead Sponsor: Shobhita Garg

Brief Summary

The purpose of this binary, non-inferiority randomized clinical controlled trial is to compare the long-term success of coronal pulpotomies in human permanent molars with irreversible pulpitis using Biodentine alone versus those performed with Biodentine and PRF. The clinical/radiographic outcomes of these cases will be evaluated at regular follow-up periods. In this binary non-inferiority randomized clinical controlled trial, treated teeth will be considered successful if there are absence of clinical symptoms and no evidence of internal or external root resorption or any further treatment (i.e., extraction due to pathology or pulpectomy) is necessary.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Last Update Posted: 2024-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Peri-apical widening (mild)may or msy not be present 2.
• Sensitivity to hot and cold 3.
• Acute pain 4.
• Tenderness on percussion may or may not be present 5.
• Mandibular first and second permanent molar 6.
• Limited carious extent that does not require prosthetic treatment.

Exclusion Criteria

• Periapical lesion 2.
• Excessive coronal damage due to caries 3.
• Pregnancy 4.
• Chronic Lesion 5.
• History of pain, long back 6.
• Presence of swelling 7.
• Presence of mobility 8.
• Periodontal involvement ( presence of pocket).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on percussion, mobility.	Follow up of 1, 3, 6 months will be taken
• Radiographic Assessment- Absence of evident pathosis, example, root	Follow up of 1, 3, 6 months will be taken
• Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender	Follow up of 1, 3, 6 months will be taken
widening.	Follow up of 1, 3, 6 months will be taken
resorption furcal pathosis, new periapical lesion and/or resolution of apical	Follow up of 1, 3, 6 months will be taken
• Pulp Sensibility Testing-Positive EPT response (higher threshold values than	Follow up of 1, 3, 6 months will be taken
baseline values)	Follow up of 1, 3, 6 months will be taken

Secondary Outcome Measures

Name	Time	Method
• Clinical Evaluation - Absence of symptomatology that is, pain, swelling, tender	on percussion, mobility.

Trial Locations

Locations (1)

Himachal dental College, sundernagar; 🇮🇳 Mandi, HIMACHAL PRADESH, India

Himachal dental College, sundernagar

🇮🇳Mandi, HIMACHAL PRADESH, India

Shobhita Garg

Principal investigator

9878239025

shobita.garg98@gmail.com