Retrospective Evaluation of the Results of Direct Pulp Capping Treatment

NCT05397964 | Enrolling By Invitation

• 1 other identifier: 362
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this retrospective study is to evaluate the vitality of teeth that had been treated with calcium hydroxide in direct pulp capping cases.

Conditions

Pulp Exposure, Dental

Keywords

direct pulp capping,; calcium hydroxide liner

Outcome Measures

Primary Outcomes (1)

• Number of participants with pulp capping treatment-related adverse events as assessed by vitality tests and intra-oral examination

  Vitality tests (cold, electrical pulp test) and radiographical examination

  up to 11 years

Secondary Outcomes (1)

• Evaluation of the restorations with FDI,World Dental Federation - clinical criteria for the evaluation of direct restorations.

  up to 11 years

Interventions

Radiopaque Calcium Hydroxide Composition DEVICE

Treatment of exposed pulp tissue with radiopaque calcium hydroxide composition as a direct pulp capping material

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population of the study group consists of a dentist's patients that have been treated with calcium hydroxide as direct pulp capping between 2011-2020.

You may qualify if:

• Has to be one of the patients treated with calcium hydroxide as direct pulp capping

You may not qualify if:

• Patients (treated with calcium hydroxide as direct pulp capping) who will not be available for the recall appointment

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University, Dental School

Istanbul, 34083, Turkey (Türkiye)

Location

Related Publications (2)

• Miles JP, Gluskin AH, Chambers D, Peters OA. Pulp capping with mineral trioxide aggregate (MTA): a retrospective analysis of carious pulp exposures treated by undergraduate dental students. Oper Dent. 2010 Jan-Feb;35(1):20-8. doi: 10.2341/09-038CR1.

  PMID: 20166407 BACKGROUND

• Al-Hiyasat AS, Barrieshi-Nusair KM, Al-Omari MA. The radiographic outcomes of direct pulp-capping procedures performed by dental students: a retrospective study. J Am Dent Assoc. 2006 Dec;137(12):1699-705. doi: 10.14219/jada.archive.2006.0116.

  PMID: 17138715 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Exposure

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Funda Öztürk Bozkurt

  fbozkurt@medipol.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosciate Professor

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 31, 2022
• Study Start: March 15, 2024
• Primary Completion: August 30, 2024
• Study Completion: October 30, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)