Indirect Pulp Treatment in Primary Teeth

Deep Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04763057
• Other study ID #: vital pulp treatment
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: marwa aly elchaghaby, phd
• Phone: 01006231612
• Email: marwaaly2003[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Deep Caries

Intervention

Drug:
• NeoPUTTY MTA
NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing
• calcium hydroxide
Calcium hydroxide the gold standard for IPT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success in term of the absence of post-operative pain	Visual analog scale	one year
Primary	Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula	Visual and clinical examinations	one year
Secondary	Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes	Radiographic examination	one year