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Indirect Pulp Treatment in Primary Teeth

Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04763057
Enrollment
88
Registered
2021-02-21
Start date
2021-04-01
Completion date
2022-10-01
Last updated
2021-02-21

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

Conditions

Deep Caries

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.

Interventions

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

DRUGcalcium hydroxide

Calcium hydroxide the gold standard for IPT

Sponsors

Cairo University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical success in term of the absence of post-operative painone yearVisual analog scale
Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistulaone yearVisual and clinical examinations

Secondary

MeasureTime frameDescription
Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changesone yearRadiographic examination

Contacts

Primary Contactmarwa aly elchaghaby, phd
marwaaly2003@yahoo.com01006231612

Outcome results

None listed

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