Deep Caries in Mature Teeth With Reversible Pulpitis

Not Applicable

Not yet recruiting

• Conditions: Deep Caries

• Registration Number: NCT07028905
• Lead Sponsor: Minia University

Brief Summary

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)

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-19
• Last Update Posted: 2025-06-19
• Study Start: 2025-06-20
• Primary Completion: 2025-07-20
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
clinical evaluation ………. Radiographic evaluation:	1year	clinical evaluation: absence of pain , pulp vitality,; .......... Radiographic evaluation: absence of any periapical lesion or recurrent caries

Secondary Outcome Measures

Name	Time	Method
histological evaluation and follow up	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.