Clinical trial NCT03606681: Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials
Official title: Evaluation of Indirect Pulp Capping in Children With Different Materials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Capping
Keywords: Dental Pulp
calcium hydroxide
Dental Pulp Capping
Lead sponsor: Altinbas University
Sponsor class: OTHER
Collaborators: name: Istanbul University
First posted: 2018-07-31
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials have been used for this procedure. The aim of this study is to evaluate the radiographic and clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and calcium hydroxide \[Ca(OH)2\] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC treatment.

Detailed description: A total of 295 teeth, including second primary molars and first permanent molars with IPC indications from healthy and cooperative children between the ages of 4-15, were included in this study. Teeth were divided into three groups according to the materials used for pulp capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89 teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material, and permanent molars were restored with the resin composite material. Restorations were evaluated with the Modified United States Public Health Service (modified USPHS) criteria. Clinical and radiographic findings were evaluated for 24 months at follow-up.

Eligibility criteria: Inclusion Criteria:

* teeth with clinical and radiographical indications of indirect pulp capping
* systemically healthy and cooperative children

Exclusion Criteria:

* teeth with contraindications of indirect pulp capping: Clinical Exclusion Criteria
* Pain (spontaneous and chronic)
* Fistula
* Acute pulpal inflammation
* Pain with percussion
* Pathologic mobility
* Abscess
* Devitality symptoms (negative response to thermal pulp test) Radiographic Exclusion Criteria
* Progression of caries lesion to pulp
* Perforation of pulp
* Intermittent or irregular lamina dura
* Expanded range of periodontal ligament
* Periapical radiolucency
* Internal and external resorption
* systemically unhealthy and uncooperative children

Primary outcomes:
measure: Clinical success rates of the indirect pulp capping biomaterials
timeFrame: 24 months
Secondary outcomes:
measure: Success rates according to Modified USPHS criterias
timeFrame: 24 months
measure: Radiographical success rates of the indirect pulp capping biomaterials
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Altinbas University
name: Aliye Tuğçe Gürcan, Assist.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Marchi JJ, de Araujo FB, Froner AM, Straffon LH, Nor JE. Indirect pulp capping in the primary dentition: a 4 year follow-up study. J Clin Pediatr Dent. 2006 Winter;31(2):68-71. doi: 10.17796/jcpd.31.2.y4um5076341226m5.
citation: Gruythuysen RJ, van Strijp AJ, Wu MK. Long-term survival of indirect pulp treatment performed in primary and permanent teeth with clinically diagnosed deep carious lesions. J Endod. 2010 Sep;36(9):1490-3. doi: 10.1016/j.joen.2010.06.006.
citation: Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel light-curable MTA-like material for pulp capping. Int Endod J. 2012 Jun;45(6):571-9. doi: 10.1111/j.1365-2591.2012.02013.x. Epub 2012 Mar 31.
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citation: George V, Janardhanan SK, Varma B, Kumaran P, Xavier AM. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study). J Indian Soc Pedod Prev Dent. 2015 Apr-Jun;33(2):104-10. doi: 10.4103/0970-4388.155118.
citation: Casagrande L, Bento LW, Dalpian DM, Garcia-Godoy F, de Araujo FB. Indirect pulp treatment in primary teeth: 4-year results. Am J Dent. 2010 Feb;23(1):34-8.