Clinical trial NCT04763057: Indirect Pulp Treatment in Primary Teeth
Official title: Calcium Hydroxide Versus NeoPUTTY MTA in Indirect Pulp Treatment of Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical success in term of the absence of post-operative pain
timeFrame: one year
measure: Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula
timeFrame: one year
Secondary outcomes:
measure: Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes
timeFrame: one year
Other outcomes:
Locations:
Study officials:
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