Clinical effectiveness of newer pulpotomy agents

Not yet recruiting

• Conditions: Pulpitis,

• Registration Number: CTRI/2022/04/042044
• Lead Sponsor: S B Divya

Brief Summary

**Background and Rationale:**

The traditional treatment modality for permanent mature teeth diagnosed with irreversible pulpitis is pulpectomy, also known as nonsurgical root canal treatment (NSRCT)[(Santos et al. 2021)](https://paperpile.com/c/aWZBvG/iMRK).However this reduces the survival time of the tooth[(Caplan et al. 2005)](https://paperpile.com/c/aWZBvG/Ssbj). Pulpotomy has been proposed as an alternative for management of irreversible pulpitis in permanent teeth with closed apices [(Alqaderi et al. 2016)](https://paperpile.com/c/aWZBvG/X0Js).Choice of pulpotomy agent is an important decision factor which has an influence on the success rate of the treatment . Concentrated Growth Factor and injectable bioceramic material iRoot Bp will be compared with MTA as pulpotomy agent .

**Materials and methods:**

Population: Patients who have permanent mature molar with symptomatic Irreversible Pulpitis

Intervention: CGF, iRootBP

Comparison: MTA

Outcome:

Group A: MTA

Group B: CGF

Group C: iRootBp

Primary outcome: Post operative pain, tenderness and swelling (yes or no)

Secondary outcome: Presence of  periapical lesions at  3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-04
• Study Start: 2022-12-05

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• 1)Patients with symptomatic Irreversible Pulpitis of age 18 to 40 years permanent mature molar teeth with symptomatic irreversible pulpitis 2)Both Maxillary and Mandibular molar teeth.
• 3. A clinical diagnosis consistent with irreversible pulpitis will be established in all cases based on a history of severe spontaneous lingering pain that could be reproduced by cold testing.
• 4)Teeth which are tender to percussion can be included but those with periapical lesions, resorption of root must be excluded.

Exclusion Criteria

• 1)Patients < 18years of age.
• 2)Patients of age > 40 years of age 3)Medically compromised patients 4)Pregnant and lactating women.
• 5)Patients undergoing fixed orthodontic therapy 6)Patients with facial deformity including cleft lip/palate.
• 7)Teeth with apical periodontitis.
• 8)Teeth with fracture or crack lines.
• 9)Teeth with abrasion on the same tooth.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post operative pain , tenderness and swelling (yes or no)	Post operative pain will be assessed after 24 hours and 48 hours, tenderness and swelling (yes or no)will be checked after 48 hours and 3 months | Pain will be assessed using Visual Analog Scale (VAS)
Pain will be assessed using Visual Analog Scale (VAS)	Post operative pain will be assessed after 24 hours and 48 hours, tenderness and swelling (yes or no)will be checked after 48 hours and 3 months | Pain will be assessed using Visual Analog Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Presence of periapical lesions at 3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis.

Trial Locations

Locations (1)

Saveetha Dental College and Hospitals; 🇮🇳 Chennai, TAMIL NADU, India

Saveetha Dental College and Hospitals

🇮🇳Chennai, TAMIL NADU, India

Dr M S Nivedhitha

Principal investigator

9840912367

nivedhithamallisureshbabu@gmail.com