comparing pulpotomy as a conservative treatment option over pulpectomy in symptomatic irreversible pulpitis using three different bioceramic materials

Comparative Evaluation of Pulpotomy as a Conservative Treatment Option in Symptomatic Irreversible Pulpitis Using Three Different Bioceramic Materials Versus Pulpectomy : A Randomized Clinical Study. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/069087

Enrollment

240

Registered

2024-06-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

None listed

Interventions

Intervention1: Pulpotomy: o Caries excavation will be done with sterile round bur (BR-S46). o The bur drop will be taken in the roof of the pulp chamber with another sterile round bur (BR-31C).[3] o

canals will be irrigated with 2.5 % sodium hypochlorite and saline to disinfect the canals at the same time remove infected dentin from the canal walls. o Canals will be dried with absorbent paper poi

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy (ASA I and II) co-operative children (Frankl Scale + and ++). 2. Children of age group 4 to 9 years. 3. The pulp of the affected primary tooth must be vital. 4. Participants with symptoms of symptomatic irreversible pulpitis in one of the primary teeth. 5. The affected primary teeth must be restorable with crowns. 6. 2/3rd of the root length should be present.

Exclusion criteria

Exclusion criteria: 1. Clinical examination of affected primary teeth reveals signs of pulpal infection (e.g. pathologic tooth mobility, parulis/fistula, or soft tissue swelling) 2. Pre-operative periapical radiograph suggests the presence of furcal radiolucency of more than Â½ the furcation to the periapical area. 3. Visual examination of pulp tissue after deroofing reveals signs of necrosis (e.g. avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate). 4. Teeth with the pulp chamber exposed to the oral environment. 5. If haemostasis is not achieved within 10 min after application of gentle pressure with sterile cotton soaked in 2.5% sodium hypochlorite. 6. Parents not willing to place full coverage restoration post-pulpotomy. 7. Medically compromised patients.

Design outcomes

Primary

Measure	Time frame
This will be performed for postoperative pain after 24 hrs and 1 week using the Numerical Rating Scale from 0-10 (NRS) from Taha et al;2021). Clinical failure will be determined (3,6 and 12 months) by the subjective symptoms as explained by the participants, and objective signs as recorded during clinical examination including abscess, swelling, sinus tract and tenderness associated with the tooth. Radiographic assessment Post-operative radiographs will be obtained at 3 months, 6 months, and 12 months.Timepoint: 12 months	—

Measure

Time frame

This will be performed for postoperative pain after 24 hrs and 1 week using the Numerical Rating Scale from 0-10 (NRS) from Taha et al;2021). Clinical failure will be determined (3,6 and 12 months) by the subjective symptoms as explained by the participants, and objective signs as recorded during clinical examination including abscess, swelling, sinus tract and tenderness associated with the tooth. Radiographic assessment Post-operative radiographs will be obtained at 3 months, 6 months, and 12 months.Timepoint: 12 months

—

Secondary

Measure	Time frame
Postoperative sensitivity & pain will be evaluatedTimepoint: 1 month	—

Countries

India

Contacts

Public ContactAmol Patil

M.A. Rangoonwala College of Dental Sciences and Research Centre

amolpatil2526@gmail.com09561042279

Outcome results