NCT05425368

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

1.2 years

First QC Date

June 14, 2022

Last Update Submit

June 15, 2022

Conditions

Deep Caries

Keywords

partial caries removalindirect pulp cappingfluorides

Outcome Measures

Primary Outcomes (1)

  • Dentin bridge formation

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

    6 months

Secondary Outcomes (4)

  • Postoperative pain

    1 week

  • Absence of sinus or fistula

    3 months

  • Absence of sinus or fistula

    6 months

  • radiographic success

    6 months

Study Arms (2)

silver diamine fluoride group

EXPERIMENTAL

partial caries removal will be carried out then Silver Diamine Fluoride will be applied as indirect pulp capping agent and rubbed for 1 minute followed by Glass ionomer filling

Drug: Silver diamine fluoride

mineral trioxide aggregate group

ACTIVE COMPARATOR

partial caries removal will be carried out then mineral trioxide aggregate will be placed as indirect pulp capping agent followed by glass ionomer filling

Drug: Mineral trioxide aggregate

Interventions

Silver diamine fluorideDRUG

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

Also known as: SDF
silver diamine fluoride group
Mineral trioxide aggregateDRUG

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

Also known as: MTA
mineral trioxide aggregate group

Eligibility Criteria

Age9 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

silver diamine fluoridemineral trioxide aggregatePemetrexed

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Officials

  • Manal Ahmed El Sayed

    Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

  • Randa Youssef Abd Al Gawad

    Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marwa Ahmed Ahmed Zaghloul

CONTACT

+201002798304marwa_zaghloul@dentistry.cu.edu.eg

Randa Youssef Abd Al Gawad

CONTACT

randa.youssef@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Two blinded (patient, radiographic assessor of results)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Study Start

August 1, 2022

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06