CClinicalTrials.gg
Sign In
CompletedNCT03606681Updated Jul 31, 2018

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

An interventional study of Calcium Hydroxide and Mineral Trioxide Aggregate in Dental Pulp Capping, sponsored by Altinbas University. Completed. Open to participants aged 4 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.

Sponsored by Altinbas University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Jul 2013, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
4 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Pulp Capping

Keywords

  • Dental Pulp
  • calcium hydroxide
  • Dental Pulp Capping
03

In context

Lead sponsor

Altinbas University is the lead sponsor of 12 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Active comparator
    Calcium Hydroxide (Dycal)

    Indirect pulp capping treatment with Calcium Hydroxide

    Drug: Calcium Hydroxide · Drug: Mineral Trioxide Aggregate · Drug: TheraCal LC

  • Experimental
    Mineral Trioxide Aggregate (ProRoot MTA)

    Indirect pulp capping treatment with Mineral Trioxide Aggregate

    Drug: Calcium Hydroxide · Drug: Mineral Trioxide Aggregate · Drug: TheraCal LC

  • Experimental
    Theracal LC

    Indirect pulp capping treatment with Theracal LC

    Drug: Calcium Hydroxide · Drug: Mineral Trioxide Aggregate · Drug: TheraCal LC

Interventions

  • DrugCalcium 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.

    Also known as: Dycal, Pulp capping agent

  • DrugMineral 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.

    Also known as: (ProRoot MTA)

  • DrugTheraCal 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.

    Also known as: resin-based calcium silicate cement

06

What researchers measure

Primary outcomes

  1. Clinical success rates of the indirect pulp capping biomaterials

    No pathological symptom like abscess, fistulas or pain at percussion

    Time frame: 24 months

Secondary outcomes

  1. Success rates according to Modified USPHS criterias

    No failed restorations during the controls

    Time frame: 24 months

  2. Radiographical success rates of the indirect pulp capping biomaterials

    No radiolucency or root resorption, healing with dentin bridge

    Time frame: 24 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 18565366 ↗
  • 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. PubMed 17315796 ↗
  • 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, Rene [corrected to Gruythuysen, Rene J M]; van Strijp, Guus [corrected to van Strijp, A J P]. PubMed 20728715 ↗
  • 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. PubMed 22469093 ↗
  • 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. doi: 10.1007/BF03262801. PubMed 21640064 ↗
  • 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. PubMed 12627699 ↗
  • 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. PubMed 25872627 ↗
  • 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. PubMed 20437725 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03606681
Lead sponsor
Altinbas University
Collaborators
Istanbul University
Responsible party
Aliye Tugce Gurcan (Assist. Prof., Altinbas University) — Principal investigator
First posted
Jul 31, 2018
Start date
Jul 2013
Primary completion
Jun 2014
Completion
Jun 2015
Last update
Jul 31, 2018

Study contacts

Aliye Tuğçe Gürcan, Assist.Prof.
principal investigator · Altinbas University

Oversight

FDA-regulated drug
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Altinbas University

Start the discussion