Indirect Pulp Treatment in Primary Molars

Study Overview
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Brief Summary
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This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

Detailed Description
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Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

Official Title
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Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Drug: Indirect pulp treatment using Dycal (TM)
* Drug: Indirect pulp treatment using Vitrebond (TM )


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: In compliance with AAPD, 2017 guidelines for pulp therapy IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult In addition to: I-Subjects: Medically free children, their parent(s) accepts to sign the informed consent. Age range from 4-8 years. II-Molars: Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars). Clinically: Normal mobility and normal appearance of gingiva (vital teeth). Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT). Exclusion criteria: I-Subjects: Uncooperative children. Parents unable to attend follow up visits (even after explaining the importance of recall visits). II-Molars: History of spontaneous pain (to exclude reversible pulpitis). Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth). Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 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 group with 1:1 allocation ratio
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPT using Dycal (TM )<br>Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal | Drug: Indirect pulp treatment using Dycal (TM)<br>* Partial caries removal and protection of the dental pulp with biocompatible material<br>* Other names: Indirect pulp capping;Drug: Indirect pulp treatment using Vitrebond (TM )<br>* Partial caries removal and protection of the dental pulp with biocompatible material<br>* Other names: Indirect pulp capping;|
| Experimental: IPT using Vitrebond (TM )<br>Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal | Drug: Indirect pulp treatment using Dycal (TM)<br>* Partial caries removal and protection of the dental pulp with biocompatible material<br>* Other names: Indirect pulp capping;Drug: Indirect pulp treatment using Vitrebond (TM )<br>* Partial caries removal and protection of the dental pulp with biocompatible material<br>* Other names: Indirect pulp capping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases reporting postoperative pain | Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure | 12 months | 
| Number of cases reporting swelling | Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure | 12 months | 
| Number of cases reporting sinus | Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure | 12 months | 
| Number of cases reporting fistula | Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure | 12 months | 
| Number of cases reporting tooth mobility | Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases reporting external root resorption | Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure | 12 months | 
| Number of cases reporting internal root resorption | Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure | 12 months | 
| Number of cases reporting furcation involvement | Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure | 12 months | 
| Number of cases reporting widening of periodontal membrane space | Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure | 12 months | 
| Number of cases reporting periapical radiolucency | Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children