Deep Caries in Mature Teeth With Reversible Pulpitis

September 22, 2025 updated by: Abeer mohamed shehata, Minia University

Clinical, Radiographical, and Histological Evaluation of Treatment Outcomes Following Different Caries Removal Strategies in Mature Permanent Teeth With Reversible Pulpitis (A Randomized Clinical Trial and Ex-vivo Study)

This clinical trial will be conducted to clinical, radiographical and histological evaluation of pulp condition with reversible pulpities after total and selective removal of primary and secondary caries (randomized clinical trial and exo-vivo study)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomized clinical trial Sample size 144 case…

Randomization method used:

Sample size calculation was performed using R statistical analysis software version 4.3.2 for Windows

Outcome variables:

Pulp vitality and post operative pain Grouping classified into four groups as follows: The first group : total caries removal of primary caries(PTCR) 27 The second group: selective caries removal of primary caries(PSCR) The third group: total caries removal of secondary caries(STCR) The fourth group : selecive caries removal of secondary caries(SSCR)

Expected Time table:

2 years Recall of patient after 3,6,9 and 12 months 6 months for writing and 6 months for data analyzed

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The patient's age from 18 years to 40 years old
  2. Non -contributory medical history (ASA1)
  3. Mature permanent posterior teeth with primary or secondary deep caries extending ≥ 2/3 of dentin
  4. The tooth should give a positive response to cold testing
  5. Clinical diagnosis of reversible pulpitis
  6. The tooth is restorable via direct restoration, probing pocket depth and mobility are within normal limits
  7. No signs of pulpal necrosis including sinus tract or swelling
  8. No radiographic evidence of periapical changes indicative of apical periodontitis

Exclusion Criteria:

  • Systemic medical conditions, pregnancy, alcoholic and smoker patients. 2- Teeth with spontaneous pain or percussion sensitivity in periodontal lesions, external or internal root resorption, sinus opening, mobility, or abscessed tooth. 3- Radiographic evidence of widened periodontal space, broken or interrupted lamina dura, and periapical radiolucency. 4- Intensified erosion damage or periodontitis. Patient reported clenching or bruxism, hopeless or non-restorable teeth. Immature teeth. 5- Patients with physical disabilities preventing tooth brushing. Patient had removable partial denture abutments, dental abscesses, pulp lesions, atypical facial pain, or pulpitis. 6- Patients had non-carious lesions like abrasion, erosion, attrition, or abfraction.

    7- Patients with history of antibiotic or analgesics intake within few days of operative intervention. 8- Patients with previously root canal-treated teeth. 9- Periodontally compromised teeth. 10-Teeth that will be extracted for periodontal or orthodontic reasons as it will conduct for histological evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Total caries removal in primary caries
Total caries removal Removal of all caries and application of bioactive material
Procedure: Total caries removal
Total caries removal and application of bioactive material
Other Names:
  • Biodentin application
Active Comparator: Total caries removal of secondary caries
Total caries removal of caries of recurrent caries
Procedure: Total caries removal
Total caries removal and application of bioactive material
Other Names:
  • Biodentin application
Active Comparator: Partial caries removal of primary caries
Partial caries removal and application of bioactive material
Procedure: Partial caries removal
Partial caries removal then application of biodentin
Other Names:
  • Biodentin
Active Comparator: Partial caries removal of secondary caries
Partical caries removal of recurrent caries
Procedure: Partial caries removal
Partial caries removal then application of biodentin
Other Names:
  • Biodentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical evaluation ………. Radiographic evaluation:
Time Frame: 1year

clinical evaluation: absence of pain , pulp vitality,

………. Radiographic evaluation: absence of any periapical lesion or recurrent caries
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological evaluation and follow up
Time Frame: 1 year
histological evaluation after one year. T (Time): follow up evaluation periods of pulp condition immediately post operative (base line ), after 3, 6, 9 and 12 month and exo-vivo study.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Abeer Mohmaed Shehata, Master, Minia University
  • Study Director: Rasha Saad, lecturer, Minia University
  • Study Director: Mohammed Torky, Associate professor, Minia University
  • Study Director: Nermin Mahmoud, Associate professor, Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 20, 2025

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 11, 2025

First Submitted That Met QC Criteria

June 11, 2025

First Posted (Actual)

June 19, 2025

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • deep caries in mature teeth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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