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NCT Number: NCT07028905

Deep Caries in Mature Teeth With Reversible Pulpitis

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)

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Total caries removal

Procedure

Total caries removal and application of bioactive material

Other names: Biodentin application

Partial caries removal

Procedure

Partial caries removal then application of biodentin

Other names: Biodentin

Primary outcomes

  1. clinical evaluation ………. Radiographic evaluation:

    Time frame: 1year

    clinical evaluation: absence of pain , pulp vitality,

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

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abeer M. Shehata, MASTER

CONTACT

[email protected]

00201094238606

Abeer M. Shehata, master

CONTACT

[email protected]

00201094830487

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 19, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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