Indirect Pulp Treatment in Primary Molars (RCT)

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Dental Caries

Treatments: Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM )

Study type: Interventional

Funder types: Other

Identifiers

NCT03770871

CEBD-CU-2014-11-3

Details and patient eligibility

About

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

Full description

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

Enrollment: 88 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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88 participants in 2 patient groups

IPT using Dycal (TM )

Active Comparator group

Description:

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

Treatment:

Drug: Indirect pulp treatment using Vitrebond (TM )

Drug: Indirect pulp treatment using Dycal (TM)

IPT using Vitrebond (TM )

Experimental group

Description:

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

Treatment:

Drug: Indirect pulp treatment using Vitrebond (TM )

Drug: Indirect pulp treatment using Dycal (TM)