Deep Caries in Mature Teeth With Reversible Pulpitis

NCT ID: NCT07028905

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-12-01

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

Conditions

Deep Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Total caries removal in primary caries

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

Group Type: ACTIVE_COMPARATOR

Total caries removal

Intervention Type: PROCEDURE

Total caries removal and application of bioactive material

Total caries removal of secondary caries

Total caries removal of caries of recurrent caries

Group Type: ACTIVE_COMPARATOR

Total caries removal

Intervention Type: PROCEDURE

Total caries removal and application of bioactive material

Partial caries removal of primary caries

Partial caries removal and application of bioactive material

Group Type: ACTIVE_COMPARATOR

Partial caries removal

Intervention Type: PROCEDURE

Partial caries removal then application of biodentin

Partial caries removal of secondary caries

Partical caries removal of recurrent caries

Group Type: ACTIVE_COMPARATOR

Partial caries removal

Intervention Type: PROCEDURE

Partial caries removal then application of biodentin

Interventions

Total caries removal

Total caries removal and application of bioactive material

Intervention Type: PROCEDURE

Partial caries removal

Partial caries removal then application of biodentin

Intervention Type: PROCEDURE

Other Intervention Names

Biodentin application; Biodentin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Abeer mohamed shehata

Abeer Mohamed Shehata

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abeer Mohmaed Shehata, Master

Role: PRINCIPAL_INVESTIGATOR

Minia University

Rasha Saad, lecturer

Role: STUDY_DIRECTOR

Minia University

Mohammed Torky, Associate professor

Role: STUDY_DIRECTOR

Minia University

Nermin Mahmoud, Associate professor

Role: STUDY_DIRECTOR

Minia University

Central Contacts

Abeer M. Shehata, MASTER

Role: CONTACT

abeer.shehata@mu.edu.eg

00201094238606

Abeer M. Shehata, master

Role: CONTACT

abeermasr@hotmail.com

00201094830487

References

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.

Reference Type: BACKGROUND

PMID: 39442480 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36110733 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37250608 (View on PubMed)

Other Identifiers

deep caries in mature teeth

Identifier Type: -

Identifier Source: org_study_id