Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials

Dental Pulp Capping Clinical Trial

Official title:

Evaluation of Indirect Pulp Capping in Children With Different Materials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03606681
• Other study ID #: 35793
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2018
• Source: Altinbas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Capping

Intervention

Drug:
• Calcium Hydroxide
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.
• Mineral Trioxide Aggregate
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.
• TheraCal LC
After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Altinbas University	Istanbul University

References & Publications (8)

Al-Zayer MA, Straffon LH, Feigal RJ, Welch KB. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003 Jan-Feb;25(1):29-36. — View Citation

Casagrande L, Bento LW, Dalpian DM, García-Godoy F, de Araujo FB. Indirect pulp treatment in primary teeth: 4-year results. Am J Dent. 2010 Feb;23(1):34-8. — View Citation

Fuks AB. Vital pulp therapy with new materials for primary teeth: new directions and treatment perspectives. J Endod. 2008 Jul;34(7 Suppl):S18-24. doi: 10.1016/j.joen.2008.02.031. Review. — View 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. — View 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. — View 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. Erratum in: J Endod. 2010 Dec;36(12):2015. Gruythuysen, René [corrected to Gruythuysen, René J M]; van Strijp, Guus [corrected to van Strijp, A J P]. — View Citation

Kotsanos N, Arizos S. Evaluation of a resin modified glass ionomer serving both as indirect pulp therapy and as restorative material for primary molars. Eur Arch Paediatr Dent. 2011 Jun;12(3):170-5. — View Citation

Marchi JJ, de Araujo FB, Fröner AM, Straffon LH, Nör JE. Indirect pulp capping in the primary dentition: a 4 year follow-up study. J Clin Pediatr Dent. 2006 Winter;31(2):68-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success rates of the indirect pulp capping biomaterials	No pathological symptom like abscess, fistulas or pain at percussion	24 months
Secondary	Success rates according to Modified USPHS criterias	No failed restorations during the controls	24 months
Secondary	Radiographical success rates of the indirect pulp capping biomaterials	No radiolucency or root resorption, healing with dentin bridge	24 months