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

NCT04018716 | Unknown DMC

• 1 other identifier: HEK 11/106
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Mineral Trioxide Aggregate; Calcium Hydroxide; Indirect Pulp Capping

Keywords

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

Outcome Measures

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.

  6 months

Study Arms (2)

MTA

EXPERIMENTAL

mineral trioxide aggregate

Device: MTA

Dycal

ACTIVE COMPARATOR

calcium hydroxide cement

Device: Dycal

Interventions

MTA DEVICE

Indirect capping with MTA

MTA

Dycal DEVICE

Indirect capping with Dycal

Dycal

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: July 7, 2015
• Primary Completion: January 7, 2016
• Study Completion: July 7, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07