Deep CariesNCT07028905
Deep Caries in Mature Teeth With Reversible Pulpitis
A study testing Total caries removal and Partial caries removal in people with Deep Caries, run by Minia University.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Total caries removal and Partial caries removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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)
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)
Read the 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
- Being tested
- Total caries removal, Partial caries removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total caries removalProcedure or surgery
Also called Biodentin application
Total caries removal and application of bioactive material
Partial caries removalProcedure or surgery
Also called Biodentin
Partial caries removal then application of biodentin
| Study group | Role | What they receive |
|---|---|---|
| Total caries removal in primary caries | Active comparator | Total caries removal Removal of all caries and application of bioactive material Receives: Procedure: Total caries removal |
| Total caries removal of secondary caries | Active comparator | Total caries removal of caries of recurrent caries Receives: Procedure: Total caries removal |
| Partial caries removal of primary caries | Active comparator | Partial caries removal and application of bioactive material Receives: Procedure: Partial caries removal |
| Partial caries removal of secondary caries | Active comparator | Partical caries removal of recurrent caries Receives: Procedure: Partial caries removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical evaluation ………. Radiographic evaluation:
clinical evaluation: absence of pain , pulp vitality,
………. Radiographic evaluation: absence of any periapical lesion or recurrent caries
Measured: 1year
Secondary outcomes (1)
histological evaluation and follow up
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start20 Oct 2025 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep CariesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer mohamed shehata, Minia University
- Investigators
- Abeer Mohmaed Shehata, Master, Principal investigator, Minia UniversityRasha Saad, lecturer, Study director, Minia UniversityMohammed Torky, Associate professor, Study director, Minia UniversityNermin Mahmoud, Associate professor, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028905
- Sponsor's protocol ID
- deep caries in mature teeth
- Status last verified
- Sep 2025
- First submitted
- 11 Jun 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39442480Ahlawat 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.
PubMed 36110733Drouri 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.
PubMed 37250608
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07028905
- Acronym / sponsor ID
- deep caries in mature teeth
- Conditions
- Deep Caries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Total caries removal in primary caries | Active comparator | Procedure: Total caries removalTotal caries removal Removal of all caries and application of bioactive material |
| Total caries removal of secondary caries | Active comparator | Procedure: Total caries removalTotal caries removal of caries of recurrent caries |
| Partial caries removal of primary caries | Active comparator | Procedure: Partial caries removalPartial caries removal and application of bioactive material |
| Partial caries removal of secondary caries | Active comparator | Procedure: Partial caries removalPartical caries removal of recurrent caries |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total caries removalAlso: Biodentin applicationTotal caries removal and application of bioactive material | Procedure or surgery | Total caries removal in primary caries, Total caries removal of secondary caries |
| Partial caries removalAlso: BiodentinPartial caries removal then application of biodentin | Procedure or surgery | Partial caries removal of primary caries, Partial caries removal of secondary caries |
Primary outcome
clinical evaluation ………. Radiographic evaluation:
Time frame: 1year
clinical evaluation: absence of pain , pulp vitality, ………. Radiographic evaluation: absence of any periapical lesion or recurrent caries
1 secondary outcome
histological evaluation and follow up
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Background: PubMed 39442480Taha 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.
- Background: PubMed 36110733Ahlawat 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.
- Background: PubMed 37250608Drouri 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.
- Individual participant dataSharing planned: No
Related trials for Deep Caries
RecruitingPhase 2
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abeer Mohmaed Shehata, Master principal investigator
Minia University
Rasha Saad, lecturer study director
Minia University
Mohammed Torky, Associate professor study director
Minia University
Questions about this trial
What is this clinical trial studying?
A study testing Total caries removal and Partial caries removal in people with Deep Caries, run by Minia University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer M. Shehata, MASTER (00201094238606, abeer.shehata@mu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical evaluation ………. Radiographic evaluation: (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07028905, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.