Reversible PulpitisNCT07147036
Effectiveness of Biodentine v/s Calcium Hydroxide as Indirect Pulp Capping Materials
A study testing Biodentine - Indirect Pulp Capping and Calcium Hydroxide - Indirect Pulp Capping in people with Reversible Pulpitis, run by Zahoor khan at 1 site in Pakistan.
Trial summary
This study compares the clinical and radiographic effectiveness of Biodentine and Calcium Hydroxide as indirect pulp capping materials in mature permanent teeth with reversible pulpitis. A total of 76 patients were randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Biodentine - Indirect Pulp Capping and Calcium Hydroxide - Indirect Pulp Capping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Feb 2023to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be included in the study:
- Age: 20 to 45 years.
- Tooth Type: Mature permanent teeth (maxillary or mandibular).
- Caries Status: Occlusal carious lesions without previous restorations.
- Pulpal Diagnosis: Reversible pulpitis confirmed by:
- Patient history and clinical examination
Show all 10Show fewer
- Positive response to thermal (cold) and electric pulp tests
- No tenderness to percussion
- Radiographic Assessment: Carious lesion corresponding to ICDAS radiographic score RC-5.
- Periapical Status: No signs of periapical radiolucency or root resorption on radiograph.
Who cannot join
- Participants will be excluded if they meet any of the following:
- Teeth exhibiting signs of irreversible pulpitis or pulp necrosis.
- Tenderness to percussion on clinical examination.
- Pulp exposure during caries removal.
- Systemic conditions that may interfere with healing or immune response, including:
- Chronic systemic illness
Show all 9Show fewer
- Immunocompromised status
- Pregnancy
- -Third molars (due to anatomical and treatment variability)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Effectiveness of Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Material in Mature Permanent Teeth
This study compares the clinical and radiographic effectiveness of Biodentine and Calcium Hydroxide as indirect pulp capping materials in mature permanent teeth with reversible pulpitis. A total of 76 patients were randomly assigned to two groups. Outcomes were assessed over 12 weeks based on pain, periapical radiolucency, and PDL widening. The goal was to determine which material better preserves pulp vitality
Read the detailed description
Introduction:
Preservation of pulp vitality is critical for the long-term health and functionality of teeth. The pulp can be compromised due to caries, trauma, or iatrogenic factors. One conservative treatment to preserve pulp vitality in teeth with deep carious lesions and reversible pulpitis is indirect pulp capping (IPC).
Traditionally, Calcium Hydroxide (Ca(OH)₂) has been the gold standard material for IPC due to its antibacterial properties and its ability to stimulate the formation of reparative dentin. However, it has several limitations such as poor bonding to dentin, high solubility, and low mechanical strength, which may affect long-term success.
Biodentine, a newer bioactive dentin substitute, has emerged as a potential alternative due to its biocompatibility, bioactivity, antibacterial effect, good sealing ability, and high compressive strength. These properties suggest Biodentine may offer superior clinical outcomes in preserving pulp vitality when used as an indirect pulp capping material.
Objective:
To compare the clinical and radiographic effectiveness of Biodentine versus Calcium Hydroxide as indirect pulp capping agents in mature permanent teeth with reversible pulpitis.
Study Design:
Type: Experimental comparative study
Setting: Department of Operative Dentistry \& Endodontics, HITEC-IMS, Taxila
Duration: 1 year (after IRB approval)
Sample Size: 76 patients (38 in each group), calculated using WHO sample size calculator
Sampling Technique: Non-probability consecutive sampling
Inclusion Criteria:
Patients aged 20-45 years
Teeth with occlusal carious lesions with ICDAS radiographic score RC-5
Vital teeth with signs of reversible pulpitis
No signs of root resorption
Exclusion Criteria:
Teeth tender to percussion
Irreversible pulpitis or non-vital pulp
Medically compromised or pregnant patients
Third molars or teeth with pulp exposure during caries excavation
Materials Used:
Group I: Biodentine (Septodont, France)
Group II: Calcium Hydroxide (Dycal)
Base Material: Self-cure Glass Ionomer Cement (Fuji, Japan)
Final Restoration: Light-cure composite resin
Disinfectant: 0.2% Chlorhexidine
Vitality Tests: Cold test and electric pulp test
Caries Removal: Round bur (#BR-45) under copious water spray
Isolation: Rubber dam
Procedure:
Pre-operative Steps:
Informed consent obtained
Patient assessment: history, clinical examination, vitality testing, radiographs
Operative Steps:
Group I (Biodentine):
Caries removed and cavity prepared
Biodentine mixed per manufacturer's instructions and placed
After 1 week, a GIC base applied
Final composite restoration placed
Post-op radiograph taken
Group II (Calcium Hydroxide):
Caries removed and cavity dried
0.5 mm Dycal applied and allowed to set (2-3 min)
GIC base placed immediately afterward
Final composite restoration after 1 week
Post-op radiograph taken
Follow-Up Intervals:
2 weeks
6 weeks
12 weeks
Evaluation Criteria:
Clinical Parameters:
Pain (reversible or persistent)
Tenderness to percussion
Response to pulp vitality tests
Radiographic Parameters:
Presence or absence of periapical radiolucency
Periodontal ligament (PDL) space widening
Data Collection Tool:
Data was recorded using a structured proforma (Annexure-C), documenting all clinical and radiographic parameters at baseline and follow-up intervals.
Statistical Analysis:
Software: SPSS Version 26
Quantitative Variables: Mean ± standard deviation (e.g., age, weight)
Qualitative Variables: Frequency and percentage (e.g., pain, radiographic changes)
Test Used: Chi-square test
Level of Significance: p < 0.05 considered statistically significant
Ethical Considerations:
Approved by Institutional Review Board (IRB) and College Ethical Committee
Written informed consent obtained in both English and Urdu
Patient confidentiality strictly maintained
Participants allowed to withdraw at any time without affecting treatment
Budget and Funding:
Funded by Dental College, HITEC-IMS, Taxila
No financial burden on participants
Estimated duration for study completion: 1 year
Expected Outcome:
The study aims to determine whether Biodentine, with its superior physical and biological properties, provides better clinical and radiographic outcomes in indirect pulp capping procedures compared to Calcium Hydroxide in mature permanent teeth.
- Conditions
- Reversible Pulpitis
- Being tested
- Biodentine - Indirect Pulp Capping, Calcium Hydroxide - Indirect Pulp Capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodentine - Indirect Pulp CappingProcedure or surgery
Caries removal under rubber dam isolation using round bur (#BR-45) and water spray
Tooth disinfection with 0.2% chlorhexidine
Mixing of Biodentine (Septodont, France) in an amalgamator (30 seconds at 4000 rpm)
Placement of Biodentine into the prepared cavity using an amalgam carrier and condensation
After 1 week: Placement of self-cure GIC (Fuji, Japan) as a base
Final restoration with light-cure composite resin
Follow-up at 2, 6, and 12 weeks
Calcium Hydroxide - Indirect Pulp CappingProcedure or surgery
Caries removal under rubber dam isolation using round bur (#BR-45) and water spray
Tooth disinfection with 0.2% chlorhexidine
Cavity dried with cotton pellet
Placement of a 0.5 mm layer of Calcium Hydroxide (Dycal)
After 2-3 minutes (setting time): Placement of self-cure GIC (Fuji, Japan)
After 1 week: Final restoration with light-cure composite resin
Follow-up at 2, 6, and 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Biodentine Group | Experimental | Participants receive Biodentine as the indirect pulp capping material Receives: Procedure: Biodentine - Indirect Pulp Capping |
| Calcium Hydroxide Group | Active comparator | Participants receive Calcium Hydroxide (Dycal) as the indirect pulp capping material Receives: Procedure: Calcium Hydroxide - Indirect Pulp Capping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment by Periapical Index (PAI)
PAI Scoring Criteria:
Score Radiographic Features Interpretation
- Normal periapical structures Healthy PDL and periapical tissues
- Small changes in bone structure (slight PDL widening) Mild changes; potentially reversible
- Changes in bone structure with mineral loss Moderate periapical inflammation
- Well-defined radiolucent area Established periapical periodontitis
- Severe radiolucency with bone destruction Advanced periapical disease
Application in my Study:
At each follow-up (2, 6, 12 weeks), periapical radiographs should be:
Evaluated using the PAI score
Compared to baseline radiographs
Scores ≤2 are generally considered favorable outcomes
Scores ≥3 indicate disease or failure
Measured: Follow-up Timeline for Each Patient: Patients will be evaluated at the following intervals after the indirect pulp capping procedure: Baseline (Initial Treatment) 2 weeks follow-up 6 weeks follow-up 12 weeks follow-up
Visual Analog Scale (VAS) for Pain Measurement
- Pain Assessment
Type: Spontaneous or provoked
Tool: Patient history and Visual Analog Scale (VAS) for Pain Measurement
Classification:
No pain
Mild/transient pain (indicative of successful pulp healing)
Moderate to severe pain (suggestive of pulpal inflammation or failure)
Interpretation:
Absence of pain considered a positive outcome.
Persistent or worsening pain may indicate treatment failure or progression to irreversible pulpitis
Visual Analog Scale (VAS) for Pain Measurement
Description:
A 10 cm horizontal line representing a continuum of pain intensity.
One end (0 cm) represents "No pain", and the other end (10 cm) represents "Worst possible pain".
Scoring Criteria:
VAS Score (cm) Pain Intensity 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe pain
Application in my Study: Patients can be asked to mark their pain level on the scale at:
Baseline
2-week
6-week
12-week follow-up visits
Measured: Patients pain level can be measured on the scale at: Baseline 2-week 6-week 12-week follow-up visits
Tenderness to Percussion
- Tenderness to Percussion
Tool: Blunt end of dental mirror gently tapped on the occlusal surface
Response Categories:
Absent: No discomfort or pain on percussion (favorable response)
Present: Pain on percussion, indicating potential periapical inflammation or pulp degeneration
Interpretation:
Lack of tenderness is a favorable clinical outcome.
Positive percussion response may suggest underlying periapical involvement or pulpal pathology.
Measured: Patients tenderness to percussion will be checked at: Baseline 2-week 6-week 12-week follow-up visits
Pulp Vitality Testing : Cold test (Endo-Ice or refrigerant spray on cotton pellet) and Electric Pulp Test (EPT)
Pulp Vitality Testing
Methods Used:
Cold test (Endo-Ice or refrigerant spray on cotton pellet)
Electric Pulp Test (EPT)
Response Categories:
Normal response: Short, sharp, non-lingering sensation (indicative of vital pulp)
Exaggerated or lingering pain: Suggestive of reversible/irreversible pulpitis
No response: Indicative of non-vital or necrotic pulp
Interpretation:
A normal response to cold or EPT at follow-up implies successful preservation of pulp vitality.
No response or lingering pain may indicate pulp necrosis or treatment failure
Measured: Patients tooth vitality testing will be done at: Baseline 2-week 6-week 12-week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start5 Feb 2023
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahoor khan
- Sponsor type
- University, hospital or other
- Collaborators
- HITEC-Institute of Medical Sciences
- Responsible party
- Sponsor-investigator, Zahoor khan, HITEC-Institute of Medical Sciences
- Investigators
- Dr Zahoor Dr Zahoor khan, BDS, FCPS, Principal investigator, Dental college HITEC-IMS TaxilaDr Zahoor khan, Principal investigator, Dental college HITEC-IMS Taxila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147036
- Sponsor's protocol ID
- Dental/HITEC/IRB/41
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effectiveness of Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Material in Mature Permanent Teeth
- ClinicalTrials.gov ID
- NCT07147036
- Acronym / sponsor ID
- Dental/HITEC/IRB/41
- Conditions
- Reversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Zahoor khanUniversity, hospital or other
- Collaborators
- HITEC-Institute of Medical Sciences
- Study start
- 5 Feb 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 28 Aug 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 study compares the clinical and radiographic effectiveness of Biodentine and Calcium Hydroxide as indirect pulp capping materials in mature permanent teeth with reversible pulpitis. A total of 76 patients were randomly assigned to two groups. Outcomes were assessed over 12 weeks based on pain, periapical radiolucency, and PDL widening. The goal was to determine which material better preserves pulp vitality
Detailed description
Introduction:
Preservation of pulp vitality is critical for the long-term health and functionality of teeth. The pulp can be compromised due to caries, trauma, or iatrogenic factors. One conservative treatment to preserve pulp vitality in teeth with deep carious lesions and reversible pulpitis is indirect pulp capping (IPC).
Traditionally, Calcium Hydroxide (Ca(OH)₂) has been the gold standard material for IPC due to its antibacterial properties and its ability to stimulate the formation of reparative dentin. However, it has several limitations such as poor bonding to dentin, high solubility, and low mechanical strength, which may affect long-term success.
Biodentine, a newer bioactive dentin substitute, has emerged as a potential alternative due to its biocompatibility, bioactivity, antibacterial effect, good sealing ability, and high compressive strength. These properties suggest Biodentine may offer superior clinical outcomes in preserving pulp vitality when used as an indirect pulp capping material.
Objective:
To compare the clinical and radiographic effectiveness of Biodentine versus Calcium Hydroxide as indirect pulp capping agents in mature permanent teeth with reversible pulpitis.
Study Design:
Type: Experimental comparative study
Setting: Department of Operative Dentistry \& Endodontics, HITEC-IMS, Taxila
Duration: 1 year (after IRB approval)
Sample Size: 76 patients (38 in each group), calculated using WHO sample size calculator
Sampling Technique: Non-probability consecutive sampling
Inclusion Criteria:
Patients aged 20-45 years
Teeth with occlusal carious lesions with ICDAS radiographic score RC-5
Vital teeth with signs of reversible pulpitis
No signs of root resorption
Exclusion Criteria:
Teeth tender to percussion
Irreversible pulpitis or non-vital pulp
Medically compromised or pregnant patients
Third molars or teeth with pulp exposure during caries excavation
Materials Used:
Group I: Biodentine (Septodont, France)
Group II: Calcium Hydroxide (Dycal)
Base Material: Self-cure Glass Ionomer Cement (Fuji, Japan)
Final Restoration: Light-cure composite resin
Disinfectant: 0.2% Chlorhexidine
Vitality Tests: Cold test and electric pulp test
Caries Removal: Round bur (#BR-45) under copious water spray
Isolation: Rubber dam
Procedure:
Pre-operative Steps:
Informed consent obtained
Patient assessment: history, clinical examination, vitality testing, radiographs
Operative Steps:
Group I (Biodentine):
Caries removed and cavity prepared
Biodentine mixed per manufacturer's instructions and placed
After 1 week, a GIC base applied
Final composite restoration placed
Post-op radiograph taken
Group II (Calcium Hydroxide):
Caries removed and cavity dried
0.5 mm Dycal applied and allowed to set (2-3 min)
GIC base placed immediately afterward
Final composite restoration after 1 week
Post-op radiograph taken
Follow-Up Intervals:
2 weeks
6 weeks
12 weeks
Evaluation Criteria:
Clinical Parameters:
Pain (reversible or persistent)
Tenderness to percussion
Response to pulp vitality tests
Radiographic Parameters:
Presence or absence of periapical radiolucency
Periodontal ligament (PDL) space widening
Data Collection Tool:
Data was recorded using a structured proforma (Annexure-C), documenting all clinical and radiographic parameters at baseline and follow-up intervals.
Statistical Analysis:
Software: SPSS Version 26
Quantitative Variables: Mean ± standard deviation (e.g., age, weight)
Qualitative Variables: Frequency and percentage (e.g., pain, radiographic changes)
Test Used: Chi-square test
Level of Significance: p < 0.05 considered statistically significant
Ethical Considerations:
Approved by Institutional Review Board (IRB) and College Ethical Committee
Written informed consent obtained in both English and Urdu
Patient confidentiality strictly maintained
Participants allowed to withdraw at any time without affecting treatment
Budget and Funding:
Funded by Dental College, HITEC-IMS, Taxila
No financial burden on participants
Estimated duration for study completion: 1 year
Expected Outcome:
The study aims to determine whether Biodentine, with its superior physical and biological properties, provides better clinical and radiographic outcomes in indirect pulp capping procedures compared to Calcium Hydroxide in mature permanent teeth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodentine Group | Experimental | Procedure: Biodentine - Indirect Pulp CappingParticipants receive Biodentine as the indirect pulp capping material |
| Calcium Hydroxide Group | Active comparator | Procedure: Calcium Hydroxide - Indirect Pulp CappingParticipants receive Calcium Hydroxide (Dycal) as the indirect pulp capping material |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age: 20 to 45 years.
- Tooth Type: Mature permanent teeth (maxillary or mandibular).
- Caries Status: Occlusal carious lesions without previous restorations.
- Pulpal Diagnosis: Reversible pulpitis confirmed by:
- Patient history and clinical examination
Key exclusion criteria (9 listed)
- Participants will be excluded if they meet any of the following:
- Teeth exhibiting signs of irreversible pulpitis or pulp necrosis.
- Tenderness to percussion on clinical examination.
- Pulp exposure during caries removal.
- Systemic conditions that may interfere with healing or immune response, including:
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 |
|---|---|---|
| Biodentine - Indirect Pulp CappingCaries removal under rubber dam isolation using round bur (#BR-45) and water spray Tooth disinfection with 0.2% chlorhexidine Mixing of Biodentine (Septodont, France) in an amalgamator (30 seconds at 4000 rpm) Placement of Biodentine into the prepared cavity using an amalgam carrier and condensation After 1 week: Placement of self-cure GIC (Fuji, Japan) as a base Final restoration with light-cure composite resin Follow-up at 2, 6, and 12 weeks | Procedure or surgery | Biodentine Group |
| Calcium Hydroxide - Indirect Pulp CappingCaries removal under rubber dam isolation using round bur (#BR-45) and water spray Tooth disinfection with 0.2% chlorhexidine Cavity dried with cotton pellet Placement of a 0.5 mm layer of Calcium Hydroxide (Dycal) After 2-3 minutes (setting time): Placement of self-cure GIC (Fuji, Japan) After 1 week: Final restoration with light-cure composite resin Follow-up at 2, 6, and 12 weeks | Procedure or surgery | Calcium Hydroxide Group |
Primary outcome
Radiographic assessment by Periapical Index (PAI)
Time frame: Follow-up Timeline for Each Patient: Patients will be evaluated at the following intervals after the indirect pulp capping procedure: Baseline (Initial Treatment) 2 weeks follow-up 6 weeks follow-up 12 weeks follow-up
PAI Scoring Criteria: Score Radiographic Features Interpretation 1. Normal periapical structures Healthy PDL and periapical tissues 2. Small changes in bone structure (slight PDL widening) Mild changes; potentially reversible 3. Changes in bone structure with mineral loss Moderate periapical inflammation 4. Well-defined radiolucent area Established periapical periodontitis 5. Severe radiolucency with bone destruction Advanced periapical disease Application in my Study: At each follow-up (2, 6, 12 weeks), periapical radiographs should be: Evaluated using the PAI score Compared to baseline radiographs Scores ≤2 are generally considered favorable outcomes Scores ≥3 indicate disease or failure
Visual Analog Scale (VAS) for Pain Measurement
Time frame: Patients pain level can be measured on the scale at: Baseline 2-week 6-week 12-week follow-up visits
1. Pain Assessment Type: Spontaneous or provoked Tool: Patient history and Visual Analog Scale (VAS) for Pain Measurement Classification: No pain Mild/transient pain (indicative of successful pulp healing) Moderate to severe pain (suggestive of pulpal inflammation or failure) Interpretation: Absence of pain considered a positive outcome. Persistent or worsening pain may indicate treatment failure or progression to irreversible pulpitis Visual Analog Scale (VAS) for Pain Measurement Description: A 10 cm horizontal line representing a continuum of pain intensity. One end (0 cm) represents "No pain", and the other end (10 cm) represents "Worst possible pain". Scoring Criteria: VAS Score (cm) Pain Intensity 0 No pain 1-3 Mild pain 4-6 Moderate pain 7-10 Severe pain Application in my Study: Patients can be asked to mark their pain level on the scale at: Baseline 2-week 6-week 12-week follow-up visits
Tenderness to Percussion
Time frame: Patients tenderness to percussion will be checked at: Baseline 2-week 6-week 12-week follow-up visits
2. Tenderness to Percussion Tool: Blunt end of dental mirror gently tapped on the occlusal surface Response Categories: Absent: No discomfort or pain on percussion (favorable response) Present: Pain on percussion, indicating potential periapical inflammation or pulp degeneration Interpretation: Lack of tenderness is a favorable clinical outcome. Positive percussion response may suggest underlying periapical involvement or pulpal pathology.
Pulp Vitality Testing : Cold test (Endo-Ice or refrigerant spray on cotton pellet) and Electric Pulp Test (EPT)
Time frame: Patients tooth vitality testing will be done at: Baseline 2-week 6-week 12-week follow-up visit
Pulp Vitality Testing Methods Used: Cold test (Endo-Ice or refrigerant spray on cotton pellet) Electric Pulp Test (EPT) Response Categories: Normal response: Short, sharp, non-lingering sensation (indicative of vital pulp) Exaggerated or lingering pain: Suggestive of reversible/irreversible pulpitis No response: Indicative of non-vital or necrotic pulp Interpretation: A normal response to cold or EPT at follow-up implies successful preservation of pulp vitality. No response or lingering pain may indicate pulp necrosis or treatment failure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- In above URL section the related article link has been provided just for reference \& support of study as my study has not been published yetLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dr Zahoor Dr Zahoor khan, BDS, FCPS principal investigator
Dental college HITEC-IMS Taxila
Dr Zahoor khan principal investigator
Dental college HITEC-IMS Taxila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodentine - Indirect Pulp Capping and Calcium Hydroxide - Indirect Pulp Capping in people with Reversible Pulpitis, run by Zahoor khan at 1 site in Pakistan.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment by Periapical Index (PAI) (time frame: Follow-up Timeline for Each Patient: Patients will be evaluated at the following intervals after the indirect pulp capping procedure: Baseline (Initial Treatment) 2 weeks follow-up 6 weeks follow-up 12 weeks follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.