Deep Caries in Mature Teeth With Reversible Pulpitis

NCT07028905 | Not Yet Recruiting

• 1 other identifier: deep caries in mature teeth
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Deep Caries

Outcome Measures

Primary Outcomes (1)

• clinical evaluation ………. Radiographic evaluation:

  clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries

  1year

Secondary Outcomes (1)

• histological evaluation and follow up

  1 year

Study Arms (4)

Total caries removal in primary caries

ACTIVE COMPARATOR

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

Procedure: Total caries removal

Total caries removal of secondary caries

ACTIVE COMPARATOR

Total caries removal of caries of recurrent caries

Procedure: Total caries removal

Partial caries removal of primary caries

ACTIVE COMPARATOR

Partial caries removal and application of bioactive material

Procedure: Partial caries removal

Partial caries removal of secondary caries

ACTIVE COMPARATOR

Partical caries removal of recurrent caries

Procedure: Partial caries removal

Interventions

Total caries removal PROCEDURE

Total caries removal and application of bioactive material

Also known as: Biodentin application

Total caries removal in primary caries; Total caries removal of secondary caries

Partial caries removal PROCEDURE

Partial caries removal then application of biodentin

Also known as: Biodentin

Partial caries removal of primary caries; Partial caries removal of secondary caries

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Minia University: lead

Related Publications (3)

• Taha NA, Ali MM, Abidin IZ, Khader YS. Pulp survival and postoperative treatment needs following selective vs. total caries removal in mature permanent teeth with reversible pulpitis: A randomized clinical trial. J Dent. 2024 Dec;151:105408. doi: 10.1016/j.jdent.2024.105408. Epub 2024 Oct 22.

  PMID: 39442480 BACKGROUND

• Ahlawat M, Grewal MS, Goel M, Bhullar HK, Saurabh, Nagpal R. Direct Pulp Capping with Mineral Trioxide Aggregate and Biodentine in Cariously Exposed Molar Teeth: 1-Year Follow-up - An In vivo Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S983-S985. doi: 10.4103/jpbs.jpbs_837_21. Epub 2022 Jul 13.

  PMID: 36110733 BACKGROUND

• Drouri S, El Merini H, Sy A, Jabri M. Evaluation of Direct and Indirect Pulp Capping With Biodentine in Vital Permanent Teeth With Deep Caries Lesions. Cureus. 2023 May 23;15(5):e39374. doi: 10.7759/cureus.39374. eCollection 2023 May.

  PMID: 37250608 BACKGROUND

Study Officials

• Abeer Mohmaed Shehata, Master

  Minia University

  PRINCIPAL INVESTIGATOR

• Rasha Saad, lecturer

  Minia University

  STUDY DIRECTOR

• Mohammed Torky, Associate professor

  Minia University

  STUDY DIRECTOR

• Nermin Mahmoud, Associate professor

  Minia University

  STUDY DIRECTOR

Central Study Contacts

Abeer M. Shehata, MASTER

CONTACT

00201094238606; abeer.shehata@mu.edu.eg

Abeer M. Shehata, master

CONTACT

00201094830487; abeermasr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Abeer Mohamed Shehata

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share