Evaluation Of Different Pulpotomy Agents Used For Treatment Of Immature Molars

NCT05347160 | Unknown

• 1 other identifier: A04080920
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The management of permanent teeth with incomplete root development with compromised pulpal integrity presents a unique challenge. The loss of pulpal vitality before the completion of dentin deposition leaves a weak root more prone to fracture as a result of the thin dentinal walls. Every attempt should be made to preserve the vitality of these immature teeth until maturation has occured.

Conditions

Infected Pulp; Root Canal Treatment

Keywords

Pulpotomy; Calcium Hydroxide; Biodentine; Platelet Rich Fibrin; Open apex; Immature root

Outcome Measures

Primary Outcomes (1)

• Percentage % of patients with Success

  Percentage of Success of treated infected immaature teeth with diffrent agent. Restorations were given the score Alpha for the ideal clinical situation, Bravo for clinically acceptable and Charlie for clinically unacceptable and in need for replacement.

  Time Frame: 2 years after restoration procedure

Study Arms (3)

calcium hydroxide : group 1

EXPERIMENTAL

Immature permanent molars with immature root filled by ca(oh)2

Procedure: Biodentine

biodentine : group 2

EXPERIMENTAL

clinically and radiographically evaluate BIODENTINE effect on permanent molars with immature root

Procedure: Biodentine

platelet rich fibrin : group 3

EXPERIMENTAL

filling of permanent molars with immature root by platelet rich fibrin

Procedure: Biodentine

Interventions

Biodentine PROCEDURE

using of biodentine , calcium hydroxide and platelet rich fibrin as pulpotomy agents

Also known as: Platelet Rich Fibrin (PRF), Calcium Hydroxide CA(oh)2

biodentine : group 2; calcium hydroxide : group 1; platelet rich fibrin : group 3

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Apparent healthy and free from any systemic diseases
• child should have restorable carious first permanent molars with immature root

You may not qualify if:

• presence of signs and symptoms of pulp degenration
• presence of internal and external root resorption

Sponsors & Collaborators

• Mansoura University: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakhalia, 35511, Egypt

Location

MeSH Terms

Interventions

tricalcium silicate; Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Salwa M Awad, Prof

  head of pediatric dentistry and public health department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluate the effect of different pulpotomy medicaments on permanent molars with immature root clinically and radiographically: 1. Calcium Hydroxide 2. Biodentine 3. Platelet Rich Fibrin

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 26, 2022
• Study Start: August 1, 2021
• Primary Completion: November 30, 2022
• Study Completion: January 1, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)