Pulpitis ReversibleNCT06240169
Effect of Age on the Success of DPC Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis
A study testing DPC with MTA in AGEI, DPC with BD in AGEI and DPC with MTA in AGEII in people with Pulpitis Reversible, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study. Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpitis Reversible
- What is being tested?
- DPC with MTA in AGEI, DPC with BD in AGEI and DPC with MTA in AGEII
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2022to 30 Mar 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients (ASA I and ASA II).
- Patients falling in the age group of 18-60 years.
- Restorable permanent mandibular posterior teeth.
- Extremely deep caries penetrating the entire thickness of dentine and exhibiting signs and symptoms of reversible pulpitis.
- Teeth responding positively to cold test and electric pulp testing with no tenderness on percussion.
Who cannot join
- Primary teeth.
- Traumatic or mechanical exposure.
- No pulp exposure after caries excavation.
- Hemostasis not achieved within 10 mins.
- Teeth with irreversible pulpitis.
- Presence of periapical lesion or evidence of internal or external resorption, calcified canals, as assessed by radiographic examination.
- Patients with periodontal disease, swelling and sinus tract.
- Immunocompromised or pregnant patients, patients with any systemic disease, and a positive history of antibiotic use within 1 month and analgesic use within week before the treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Age on the Success of Direct Pulp Capping Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis: A Prospective Clinical Study.
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim \& Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents.
Read the detailed description
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim \& Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents based on clinical and radiographic findings and assessment of post operative pain for 7 days post treatment.
Statistical method: - Data analysis by suitable statistical method.
- Conditions
- Pulpitis Reversible
- Being tested
- DPC with MTA in AGEI, DPC with BD in AGEI, DPC with MTA in AGEII, DPC with BD in AGEII
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPC with MTA in AGEIProcedure or surgery
DPC using MTA in 18-40 years
DPC with BD in AGEIProcedure or surgery
DPC using BD in 18-40 years
DPC with MTA in AGEIIProcedure or surgery
DPC using MTA in 41-60Years
DPC with BD in AGEIIProcedure or surgery
DPC using BD in 41-60Years
| Study group | Role | What they receive |
|---|---|---|
| DPC in AGE I with MTA | Experimental | DPC using MTA in Age group I i.e. 18-40years. Receives: Procedure: DPC with MTA in AGEI |
| DPC in AGE I with BD | Experimental | DPC using BD in Age group I i.e. 18-40years. Receives: Procedure: DPC with BD in AGEI |
| DPC in AGE II with MTA | Experimental | DPC using MTA in Age group II i.e. 41-60years Receives: Procedure: DPC with MTA in AGEII |
| DPC in AGE II with BD | Experimental | DPC using BD in Age group II i.e. 41-60years Receives: Procedure: DPC with BD in AGEII |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.
CLINICAL SUCCESS CRITERIA
- Absence of sign and symptoms of pain on stimulus or spontaneous pain.
- Absence of tenderness to palpation or percussion and presence of functional tooth.
- Absence of any soft tissue swelling sinus or fistula.
- Normal tooth mobility and no periodontal probing depth.
- Positive response to pulp sensibility test (cold and EPT).
RADIOGRAPHIC SUCCESS CRITERIA
- Periapical Index (PAI) score ≤2.
- Absence of external or internal root resorption.
Also, to evaluate the effect of age on the success of procedure.
Measured: Baseline to 18 months
Secondary outcomes (1)
Post operative pain Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment.
To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain
Measured: Base line to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Jun 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis ReversibleStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Tewari, Principal investigator, pgids rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240169
- Sponsor's protocol ID
- Harshita Wadhwa
- Status last verified
- Jan 2024
- First submitted
- 14 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- 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 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on the Success of Direct Pulp Capping Using Bio-ceramic Materials in Cariously Exposed Teeth With Reversible Pulpitis: A Prospective Clinical Study.
- ClinicalTrials.gov ID
- NCT06240169
- Acronym / sponsor ID
- Harshita Wadhwa
- Conditions
- Pulpitis Reversible
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 2 Feb 2024 (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.
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim \& Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents.
Detailed description
Study Title: - Effect of age on the success of direct pulp capping using bio-ceramic materials in cariously exposed teeth with reversible pulpitis: A Prospective clinical study.
Rationale: - Preservation of pulp vitality is a critical factor in long-term tooth survival. In deep carious lesion with reversible pulpitis, vital pulp therapy procedures in the form of direct pulp capping(DPC)is more conservative treatment strategy, based on the premise that a biologically active material placed in direct contact with the pulp wound can determine the pulpal response and result in the development of a reparative hard tissue bridge to preserve pulp vitality. Patient's age may have a role in the survival rate after direct pulp capping and the role of the pulp capping material has been recognized as an important parameter for the success of treatment.
Research Question : Does age has any influence on the success of DPC procedure and is there any difference between MTA and Biodentine as DPC material in cariously exposed permanent teeth with reversible pulpitis? Aim \& Objectives- To evaluate the effect of age on success of Direct Pulp Capping, to evaluate the success of MTA and Biodentine as direct pulp capping agents based on clinical and radiographic findings and assessment of post operative pain for 7 days post treatment.
Statistical method: - Data analysis by suitable statistical method.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DPC in AGE I with MTA | Experimental | Procedure: DPC with MTA in AGEIDPC using MTA in Age group I i.e. 18-40years. |
| DPC in AGE I with BD | Experimental | Procedure: DPC with BD in AGEIDPC using BD in Age group I i.e. 18-40years. |
| DPC in AGE II with MTA | Experimental | Procedure: DPC with MTA in AGEIIDPC using MTA in Age group II i.e. 41-60years |
| DPC in AGE II with BD | Experimental | Procedure: DPC with BD in AGEIIDPC using BD in Age group II i.e. 41-60years |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy patients (ASA I and ASA II).
- Patients falling in the age group of 18-60 years.
- Restorable permanent mandibular posterior teeth.
- Extremely deep caries penetrating the entire thickness of dentine and exhibiting signs and symptoms of reversible pulpitis.
- Teeth responding positively to cold test and electric pulp testing with no tenderness on percussion.
Key exclusion criteria (8 listed)
- Primary teeth.
- Traumatic or mechanical exposure.
- No pulp exposure after caries excavation.
- Hemostasis not achieved within 10 mins.
- Teeth with irreversible pulpitis.
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 |
|---|---|---|
| DPC with MTA in AGEIDPC using MTA in 18-40 years | Procedure or surgery | DPC in AGE I with MTA |
| DPC with BD in AGEIDPC using BD in 18-40 years | Procedure or surgery | DPC in AGE I with BD |
| DPC with MTA in AGEIIDPC using MTA in 41-60Years | Procedure or surgery | DPC in AGE II with MTA |
| DPC with BD in AGEIIDPC using BD in 41-60Years | Procedure or surgery | DPC in AGE II with BD |
Primary outcome
clinical and radiographic success rates and evaluation of the effect of age on the success of procedure.
Time frame: Baseline to 18 months
CLINICAL SUCCESS CRITERIA * Absence of sign and symptoms of pain on stimulus or spontaneous pain. * Absence of tenderness to palpation or percussion and presence of functional tooth. * Absence of any soft tissue swelling sinus or fistula. * Normal tooth mobility and no periodontal probing depth. * Positive response to pulp sensibility test (cold and EPT). RADIOGRAPHIC SUCCESS CRITERIA * Periapical Index (PAI) score ≤2. * Absence of external or internal root resorption. Also, to evaluate the effect of age on the success of procedure.
1 secondary outcome
Post operative pain Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment. Secondary outcome measure will be pain intensity after treatment.
Time frame: Base line to 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- 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.
Sanjay Tewari principal investigator
pgids rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPC with MTA in AGEI, DPC with BD in AGEI and DPC with MTA in AGEII in people with Pulpitis Reversible, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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 India. 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?
Results are not available in the source record.
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?
clinical and radiographic success rates and evaluation of the effect of age on the success of procedure. (time frame: Baseline to 18 months). 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 2 Feb 2024.