Indirect Pulp Treatment in Primary Teeth

NCT04763057 | Unknown

• 1 other identifier: vital pulp treatment
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Radiographic success in term of the absence of any adverse radiographic findings (eg. internal or external root resorption or other pathologic changes

  one year

Study Arms (2)

indirect pulp treatment with NeoPUTTY MTA

EXPERIMENTAL

Drug: NeoPUTTY MTA

indirect pulp treatment with calcium hydroxide

ACTIVE COMPARATOR

Drug: calcium hydroxide

Interventions

NeoPUTTY MTA DRUG

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

indirect pulp treatment with NeoPUTTY MTA

calcium hydroxide DRUG

Calcium hydroxide the gold standard for IPT

indirect pulp treatment with calcium hydroxide

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Central Study Contacts

marwa aly elchaghaby, phd

CONTACT

01006231612; marwaaly2003@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2022
• Last Updated: February 21, 2021

Record last verified: 2021-02