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Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Mineral Trioxide Aggregate as Indirect Pulp Capping Agents in Deeply Carious Young Permanent Molars Randomized Controlled Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05425368
Enrollment
30
Registered
2022-06-21
Start date
2022-08-01
Completion date
2023-12-31
Last updated
2022-06-21

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

Conditions

Deep Caries

Keywords

partial caries removal, indirect pulp capping, fluorides

Brief summary

Aim of the study: To evaluate clinical and radiographic success rates of silver diamine fluoride versus mineral trioxide aggregate as indirect pulp capping agents in deeply carious young first permanent molars.

Detailed description

Indirect pulp treatment has become a common maneuver in vital pulp therapy in recent years and is a procedure performed in teeth with deep carious lesions approximating the pulp but without any signs or symptoms of irreversible pulpal changes. Silver Diamine Fluoride is used to arrest caries lesions in primary teeth but according to the AAPD,2021 more research is needed on the use of SDF to arrest caries lesions in permanent teeth.

Interventions

DRUGSilver diamine fluoride

First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.

DRUGMineral trioxide aggregate

First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

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

Masking description

Two blinded (patient, radiographic assessor of results)

Eligibility

Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Patient and parent showing cooperation and compliance. * Children 9-14 years old * Vital deeply carious young first permanent molar(s) with complete root formation * Asymptomatic teeth or without clinical symptoms of spontaneous pain * Both genders will be included.

Exclusion criteria

* Children unable to return for recall visits. * Any clinical signs of irreversible pulpitis or pulp necrosis (spontaneous pain, pain on percussion, abscess, sinus). * Any radiographic sign of irreversible pulp pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)

Design outcomes

Primary

MeasureTime frameDescription
Dentin bridge formation6 monthsDentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination

Secondary

MeasureTime frameDescription
Postoperative pain1 weekPostoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no)
Absence of sinus or fistula3 monthsIntraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent)
radiographic success6 monthsAbsence of any adverse radiographic findings (Periodontal membrane space widening, bone resorption, pulp stones will be assessed if present or absent by digital radiographic examination, Binary (present or absent)

Contacts

Primary ContactMarwa Ahmed Ahmed Zaghloul
marwa_zaghloul@dentistry.cu.edu.eg+201002798304
Backup ContactRanda Youssef Abd Al Gawad
randa.youssef@dentistry.cu.edu.eg

Outcome results

None listed

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