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Indirect Pulp Treatment in Primary Molars

NCT ID: NCT03770871

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-07-31

Brief Summary

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This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

Detailed Description

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Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

Conditions

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Dental Caries

Keywords

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indirect pulp primary calcium hydroxide resin modified glass ionomer Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group with 1:1 allocation ratio
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Double blinded

Study Groups

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IPT using Dycal (TM )

Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal

Group Type ACTIVE_COMPARATOR

Indirect pulp treatment using Dycal (TM)

Intervention Type DRUG

Partial caries removal and protection of the dental pulp with biocompatible material

Indirect pulp treatment using Vitrebond (TM )

Intervention Type DRUG

Partial caries removal and protection of the dental pulp with biocompatible material

IPT using Vitrebond (TM )

Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

Group Type EXPERIMENTAL

Indirect pulp treatment using Dycal (TM)

Intervention Type DRUG

Partial caries removal and protection of the dental pulp with biocompatible material

Indirect pulp treatment using Vitrebond (TM )

Intervention Type DRUG

Partial caries removal and protection of the dental pulp with biocompatible material

Interventions

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Indirect pulp treatment using Dycal (TM)

Partial caries removal and protection of the dental pulp with biocompatible material

Intervention Type DRUG

Indirect pulp treatment using Vitrebond (TM )

Partial caries removal and protection of the dental pulp with biocompatible material

Intervention Type DRUG

Other Intervention Names

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Indirect pulp capping Indirect pulp capping

Eligibility Criteria

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Inclusion Criteria

In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"

In addition to:

I-Subjects:

1. Medically free children, their parent(s) accepts to sign the informed consent.
2. Age range from 4-8 years.

II-Molars:

1. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion Criteria

I-Subjects:

1. Uncooperative children.
2. Parents unable to attend follow up visits (even after explaining the importance of recall visits).

II-Molars:

1. History of spontaneous pain (to exclude reversible pulpitis).
2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Farouk Rashed

Researcher assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shereen E Taha, Professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Oral and Dental Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CEBD-CU-2014-11-3

Identifier Type: -

Identifier Source: org_study_id