Silver Diamine Fluoride After Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries

Study Overview
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Brief Summary
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This study is comparing between the Silver Diamine Fluoride after minimal caries removal versus glass ionomer in permanent teeth with open apex

Detailed Description
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The study will be carried on young permanent molars with open apices & with deep caries. Incomplete caries removal and application of indirect pulp capping materials where Silver Diamine Fluoride (Group I) will be compared with glass ionomer only (group II). Then final restoration with composite resin for both groups. Children will be followed up for 9 months.

Official Title
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Postoperative Pain After Application of Silver Diamine Fluoride and Glass Ionomer Versus Glass Ionomer Alone Following Minimal Caries Removal Technique in Asymptomatic Young Permanent Teeth With Deep Caries. A Randomized Pilot Study.

Conditions
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Deep Caries

Intervention / Treatment
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* Drug: Silver Diamine Fluoride
* Drug: Glass Ionomer


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients free from any systematic diseases. Young permanent molars with incompletely formed roots having deep carious lesions according to clinical and radiographic examination and at risk of pulp exposure if complete caries is removed. Absence of clinical pathologic signs (fistula, swelling and abnormal tooth mobility) The absence of clinical symptoms of irreversible pulpitis. Absence of adverse radiographic findings (interradicular or periapical radiolucencies, thickening of the periodontal space, internal and external root resorption). Compliant patient/ parent. Exclusion criteria: Teeth with previous restorative treatment. Unrestorable teeth. Uncooperative patients.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: parallel two arm groups with 1:1 allocation ratio
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silver Diamine Fluoride<br>Silver Diamine fluoride will be applied after after minimal caries removal then glass ionomer over it followed by composite resin restoration. | Drug: Silver Diamine Fluoride<br>* Indirect pulp capping material<br>* Other names: SDF;Drug: Glass Ionomer<br>* Indirect pulp capping material<br>* Other names: GI;|
| Active Comparator: Glass Ionomer<br>Glass ionomer will be applied after minimal caries removal followed by composite resin restoration. | Drug: Glass Ionomer<br>* Indirect pulp capping material<br>* Other names: GI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | Will be assessed by questioning the patient or the guardian whether there is postoperative pain or not, Binary (yes or no) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth vitality | Will be assessed by Vitality test using thermal stimulation, binary (yes or no) | 9 months | 
| Abscess | Will be assessed intraoral Clinical examination whether there is swelling or not, binary (yes or no) | 9 months | 
| Pain on percussion | Will be assessed by Percussion test by using the back of the mirror on the tooth, binary (yes or no) | 9 months | 
| Root lengthening | Will be assessed measuring the root length by mm on the digital radiography (digora software) | 9 months |