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Dental Pulp CappingNCT03606681

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

A study testing Calcium Hydroxide, Mineral Trioxide Aggregate and TheraCal LC in people with Dental Pulp Capping, run by Altinbas University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 4 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Dental Pulp Capping
What is being tested?
Calcium Hydroxide, Mineral Trioxide Aggregate and TheraCal LC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Jul 2013to Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • teeth with contraindications of indirect pulp capping: Clinical Exclusion Criteria
  • Pain (spontaneous and chronic)
  • Fistula
  • Acute pulpal inflammation
  • Pain with percussion
  • Pathologic mobility
Show all 15Show fewer
  • 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

About this study

Official title: Evaluation of Indirect Pulp Capping in Children With Different Materials

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.

Being tested
Calcium Hydroxide, Mineral Trioxide Aggregate, TheraCal LC
Keywords
Dental Pulp, calcium hydroxide, Dental Pulp Capping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcium HydroxideDrug

    Also called Dycal, Pulp capping agent

    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 AggregateDrug

    Also called (ProRoot MTA)

    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 LCDrug

    Also called resin-based calcium silicate cement

    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.

Study groups in NCT03606681
Study groupRoleWhat they receive
Calcium Hydroxide (Dycal)Active comparatorIndirect pulp capping treatment with Calcium Hydroxide
Receives: Drug: Calcium Hydroxide; Drug: Mineral Trioxide Aggregate; Drug: TheraCal LC
Mineral Trioxide Aggregate (ProRoot MTA)ExperimentalIndirect pulp capping treatment with Mineral Trioxide Aggregate
Receives: Drug: Calcium Hydroxide; Drug: Mineral Trioxide Aggregate; Drug: TheraCal LC
Theracal LCExperimentalIndirect pulp capping treatment with Theracal LC
Receives: Drug: Calcium Hydroxide; Drug: Mineral Trioxide Aggregate; Drug: TheraCal LC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical success rates of the indirect pulp capping biomaterials

    No pathological symptom like abscess, fistulas or pain at percussion

    Measured: 24 months

Secondary outcomes (2)

  1. Success rates according to Modified USPHS criterias

    No failed restorations during the controls

    Measured: 24 months

  2. Radiographical success rates of the indirect pulp capping biomaterials

    No radiolucency or root resorption, healing with dentin bridge

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2018
  2. Study startJul 2013
  3. Primary completionJun 2014
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03606681
Sponsor's protocol ID
35793
Status last verified
Jul 2018
First submitted
2 Jul 2018
Last updated
31 Jul 2018
Results posted
No
FDA-regulated drug
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Calcium Hydroxide, Mineral Trioxide Aggregate and TheraCal LC in people with Dental Pulp Capping, run by Altinbas University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical success rates of the indirect pulp capping biomaterials (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03606681, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.

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