Comparing Two Indirect Pulp Capping Agents for Permanent Teeth

Study Overview
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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.

Official Title
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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

Conditions
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Deep Caries

Intervention / Treatment
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* Drug: Silver diamine fluoride
* Drug: Mineral trioxide aggregate


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: silver diamine fluoride group<br>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<br>* First permanent molars in this group will receive 38% silver diamine fluoride as an indirect pulp capping material.<br>* Other names: SDF;|
| Active Comparator: mineral trioxide aggregate group<br>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<br>* First permanent molars in this group will receive mineral trioxide aggregate as an indirect pulp capping material.<br>* Other names: MTA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dentin bridge formation | Dentin bridge formation will be measured in millimeters on standardized digital radiographs taken by Digital Radiographic examination | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no) | 1 week | 
| Absence of sinus or fistula | Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent) | 3 months | 
| Absence of sinus or fistula | Intraoral Visual examination will be carried out to assess if there is a sinus or fistula, Binary (present/absent) | 6 months | 
| radiographic success | Absence 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) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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partial caries removal, indirect pulp capping, fluorides