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Status unknownNCT04018716Updated Jul 16, 2019

Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions

An interventional study of MTA and Dycal in Mineral Trioxide Aggregate, Calcium Hydroxide and Indirect Pulp Capping, sponsored by Hacettepe University. Status unknown. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-16.

Sponsored by Hacettepe University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 4 years after the study started (first participant enrolled Jul 2015, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

Aim of this clinical study is to compare the clinical success of two lining materials regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms

Read the detailed description

Aim of this clinical study is to compare the clinical outcomes of mineral trioxide aggregate (MTA) cavity lining with calcium hydroxide (Ca(OH)2) regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

Materials and Methods: A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms. The data will be analyzed with Pearson chi-square, Fisher exact and logrank statistics tests (p \< 0.05). The Kaplan-Meier survival analysis will be conducted to reveal the survival rate.

02

Conditions studied

  • Mineral Trioxide Aggregate
  • Calcium Hydroxide
  • Indirect Pulp Capping

Keywords

  • deep dentin caries
  • randomized clinical trial
  • mineral trioxide aggregate
  • calcium hydroxide
  • total caries excavation
03

In context

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).
  2. Restorable by direct restoration and functional permanent posterior teeth,
  3. Positive response to electric pulp testing and negative response to thermal testing.

Exclusion criteria

Exclusion Criteria:

  1. Two or more cuspal loss 2. Caries beneath the gingival margin 3. Spontaneous pain history 4. Presence of any periapical pathology 5. Immature teeth with open apex 6. Pathologic mobility

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
73 participants (estimated)

Study arms

  • Experimental
    MTA

    mineral trioxide aggregate

    Device: MTA

  • Active comparator
    Dycal

    calcium hydroxide cement

    Device: Dycal

Interventions

  • DeviceMTA

    Indirect capping with MTA

  • DeviceDycal

    Indirect capping with Dycal

06

What researchers measure

Primary outcomes

  1. Evaluating of clinical success of restorations

    The treatment consequence was judged as "clinically successful" when the following criteria were met: positive response to electric pulp testing, negative response to cold stimuli by air-water shrinkage, no general pain, normal response to tactile tests or triggered pain not lingering, no evidence of abscess, sinus tract and no abnormal tooth mobility. These teeth were considered to be "clinically healthy" and the treatment was successful.

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04018716
Lead sponsor
Hacettepe University
Responsible party
Uzay Koc (Principal Investigator, Hacettepe University) — Principal investigator
First posted
Jul 12, 2019
Start date
Jul 7, 2015
Primary completion
Jan 7, 2016
Completion
Jul 7, 2019 (estimated)
Last update
Jul 16, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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