Indirect Pulp Treatment in Primary Teeth

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

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.

Study Overview

• Status: Unknown
• Conditions: Deep Caries
• Intervention / Treatment: Drug: NeoPUTTY MTA; Drug: calcium hydroxide

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.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: indirect pulp treatment with NeoPUTTY MTA	Drug: NeoPUTTY MTA; NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing
Active Comparator: indirect pulp treatment with calcium hydroxide	Drug: calcium hydroxide; Calcium hydroxide the gold standard for IPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success in term of the absence of post-operative pain	Visual analog scale	one year
Clinical success in term of the absence of pain on percussion, swelling, sinus, or fistula	Visual and clinical examinations	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: February 17, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: vital pulp treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No