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

NCT05554952 | Unknown

• 1 other identifier: 526_1 /11/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Indirect Pulp Capping; Pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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: 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

  2 years follow up

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Indirect pulp capping with MTA

Combination Product: MTA

Group 2

ACTIVE COMPARATOR

Pulpotomy with MTA

Combination Product: MTA

Interventions

MTA COMBINATION_PRODUCT

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.

Group 1; Group 2

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (2)

Minia University

Minya, 2422998, Egypt

Location

Minia University

Minya, Egypt

Location

MeSH Terms

Interventions

Pemetrexed

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in pediatric dentistry department faculty of dentistry assuit university

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 26, 2022
• Study Start: November 1, 2021
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

EG (2)