Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

NCT ID: NCT05425368

Last Updated: 2022-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Deep Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Two blinded (patient, radiographic assessor of results)

Study Groups

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silver diamine fluoride group

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

Group Type EXPERIMENTAL

Silver diamine fluoride

Intervention Type DRUG

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

mineral trioxide aggregate group

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

Group Type ACTIVE_COMPARATOR

Mineral trioxide aggregate

Intervention Type DRUG

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

Interventions

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Silver diamine fluoride

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

Intervention Type DRUG

Mineral trioxide aggregate

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

Intervention Type DRUG

Other Intervention Names

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SDF MTA

Eligibility Criteria

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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)
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Ahmed Ahmed Zaghloul

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manal Ahmed El Sayed

Role: PRINCIPAL_INVESTIGATOR

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

Randa Youssef Abd Al Gawad

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

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Marwa Ahmed Ahmed Zaghloul

Role: CONTACT

+201002798304

Randa Youssef Abd Al Gawad

Role: CONTACT

Other Identifiers

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Indirect pulp capping

Identifier Type: -

Identifier Source: org_study_id

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