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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05554952
Enrollment
100
Registered
2022-09-26
Start date
2021-11-01
Completion date
2023-11-30
Last updated
2022-09-26

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

Conditions

Indirect Pulp Capping, Pulpotomy

Brief 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.

Detailed 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

Interventions

COMBINATION_PRODUCTMTA

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.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical and radiographic evaluation2 years follow upThe 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: 1. pain 2. tenderness to palpation or percussion 3. gingival swelling or sinus tract 4. purulent exudate expressed from the gingival margin 5. abnormal tooth mobility Radiographic criteria: 1. periapical radiolucency 2. widening in peridontal ligament space

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026