Indirect Pulp Treatment in Primary Teeth

NCT ID: NCT04763057

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-10-01

Brief Summary

Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.

Detailed Description

Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.

Calcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

indirect pulp treatment with NeoPUTTY MTA

Group Type: EXPERIMENTAL

NeoPUTTY MTA

Intervention Type: DRUG

NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing

indirect pulp treatment with calcium hydroxide

Group Type: ACTIVE_COMPARATOR

calcium hydroxide

Intervention Type: DRUG

Calcium hydroxide the gold standard for IPT

Interventions

NeoPUTTY MTA

NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing

Intervention Type: DRUG

calcium hydroxide

Calcium hydroxide the gold standard for IPT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.

• Extension of carious lesion such that complete caries removal would risk pulp exposure.
• History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.
• Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.

Exclusion Criteria

• • History of spontaneous sharp, penetrating pain, or tenderness on percussion

• Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.
• Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
• Pulp exposure during caries removal.
• Parental refusal for participation.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

marwa aly fouad elchaghaby

Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

marwa aly elchaghaby, phd

Role: CONTACT

marwaaly2003@yahoo.com

01006231612

Other Identifiers

vital pulp treatment

Identifier Type: -

Identifier Source: org_study_id