Deep Caries in Mature Teeth With Reversible Pulpitis

Minia University

Status: Not yet enrolling

Conditions: Deep Caries

Treatments: Procedure: Partial caries removal; Procedure: Total caries removal

Study type: Interventional

Funder types: Other

Identifiers

NCT07028905

deep caries in mature teeth

Details and patient eligibility

About

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)

Full 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

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 4 patient groups

Total caries removal in primary caries

Active Comparator group

Description:

Total caries removal Removal of all caries and application of bioactive material

Treatment:

Procedure: Total caries removal

Total caries removal of secondary caries

Active Comparator group

Description:

Total caries removal of caries of recurrent caries

Treatment:

Procedure: Total caries removal

Partial caries removal of primary caries

Active Comparator group

Description:

Partial caries removal and application of bioactive material

Treatment:

Procedure: Partial caries removal

Partial caries removal of secondary caries

Active Comparator group

Description:

Partical caries removal of recurrent caries

Treatment:

Procedure: Partial caries removal