Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries

Pulpotomy Clinical Trial

Official title:

Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05554952
• Other study ID #: 526_1 /11/2021
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 2023

Study information

• Verified date: September 2022
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.

Description:

Output patients coming to Pediatric dentistry department Minia University, selected randomly to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period an equivalent parallel randomized controlled trial

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

Inclusion Criteria:

• - 4 to 6 years old patients presented with deep carious lesions in primary molars.

• Apparently healthy children (ASA I, II classification).

• Co-operative children (Rating 3 & 4 according to Frankle classification)

Exclusion Criteria:

A) Clinical:

• Non restorable primary molars.

• Presence of clinical pathology.

• Presence of mobility or tenderness to percussion.

• Spontaneous pain.

B) Radiographic:

• Pre-operative radiographs showed external or internal root resorption.

• Presence of furcal radiolucency.

• Presence of periapical radiolucency or widened periodontal ligament space

• More than one-third root resorption detected.

Related Conditions & MeSH terms

• Indirect Pulp Capping
• Pulpotomy

Intervention

Combination Product:
• MTA
Mineral trioxide aggregate (MTA) is composed of Portland cement, with 4:1 addition of bismuth oxide added so that the material can be detected on a radiograph. The cement is made up of calcium, silicon and aluminium. The main constituent phases are tricalcium and dicalcium silicate and tricalcium aluminate.

Locations

Country	Name	City	State
Egypt	Minia University	Minya
Egypt	Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and radiographic evaluation	The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present: Clinical criteria: pain; tenderness to palpation or percussion; gingival swelling or sinus tract; purulent exudate expressed from the gingival margin; abnormal tooth mobility; Radiographic criteria: periapical radiolucency; widening in peridontal ligament space	2 years follow up