Moderate PulpitisNCT06447753
COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS
A study testing Direct pulp capping and Complete Pulpotomy in people with Moderate Pulpitis, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate Pulpitis
- What is being tested?
- Direct pulp capping and Complete Pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jun 2023to 30 Nov 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
- 1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1 st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
- -
Who cannot join
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
- History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
- Internal/external resorption.
- Contributory medical history (alcoholism, smokers, diabetic, hypertension, drug dependency, Heart or valve disease, hepatitis, herpes, immunodeficiency (HIV), infectious diseases, kidney or liver, migraine) -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Sakshi Bansal, 8570018172, bansal9sakshi@gmail.com
About this study
Official title: COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS: RANDOMIZED CLINICAL TRIAL
Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial
Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Read more
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?
Read the detailed description
Rationale: Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristic, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Aim: To compare the outcome of direct pulp capping and complete pulpotomy in mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
- To evaluate the clinical and radiographic success of direct pulp capping in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate the clinical and radiographic success of complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate pain incidence and severity after direct pulp capping and complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis
P (Population) - Mature Permanent Mandibular molars with clinical signs of moderate pulpitis I (Intervention) -Direct pulp capping C (Comparison) - Complete pulpotomy O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
- To assess incidence and reduction in pain post operatively at every 24 hours till 1 week
- Conditions
- Moderate Pulpitis
- Being tested
- Direct pulp capping, Complete Pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp cappingProcedure or surgery
after caries excavation, the pulp will be inspected visually. If bleeding present, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Cases in which bleeding will not stop within 6 minutes will be excluded from the study and further managed by RCT. The exposed pulp will be capped with MTA which will be freshly mixed according to manufacturer's instructions and placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier following which the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. Then tooth will be restored using composite resin following etch and rinse technique.
Complete PulpotomyProcedure or surgery
exposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant 28to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 6 minutes. After hemostasis, ProRoot MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier. After placement, the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. The tooth then will be restored using composite resin following etch and rinse technique.
| Study group | Role | What they receive |
|---|---|---|
| Direct pulp capping | Experimental | Not described Receives: Procedure: Direct pulp capping |
| Complete pulpotomy | Active comparator | Not described Receives: Procedure: Complete Pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic success
Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment.
No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic6 et al.
Measured: 12 months
Secondary outcomes (1)
Pain incidence and reduction
Patients will be informed that they may experience pain in the days after treatment and will be instructed to record their pain at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, to be submitted after 1 week. They will be instructed to use analgesics (Ibuprofen 400 mg every 6-8 h), if needed for pain relief. They will be requested to note down the details of analgesic intake on the pain form regarding the number of doses required, timing of the dose and whether it provided adequate pain relief or not (yes/no). 29 Visual analogue scale (VAS) from 0 to 100 will be used to record preoperative and post
-operative pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start1 Jun 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Tewari, MDS, Study director, pgids rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447753
- Sponsor's protocol ID
- Sakshi
- Status last verified
- Jun 2024
- First submitted
- 2 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE EVALUATION OF DIRECT PULP CAPPING AND COMPLETE PULPOTOMY IN MATURE PERMANENT MANDIBULAR MOLARS WITH CLINICAL SIGNS INDICATIVE OF MODERATE PULPITIS: RANDOMIZED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT06447753
- Acronym / sponsor ID
- Sakshi
- Conditions
- Moderate Pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 7 Jun 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.
Title: Comparative evaluation of direct pulp capping and complete pulpotomy in mature permanent mandibular molars with clinical signs indicative of moderate pulpitis: Randomized Clinical Trial
Rationale: According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Research Question Does Direct Pulp Capping have comparable outcome with complete pulpotomy in mature permanent teeth with clinical signs indicative of moderate pulpitis?
Detailed description
Rationale: Vital pulp therapy has been traditionally recommended only in teeth with reversible pulpitis with no periapical pathologies or in teeth with either mechanical pulp exposure or recent traumatic exposure. Clinical symptoms such as characteristic, severity and intensity of pre-operative pain do not accurately talk about the status of the pulp inflammation and the depth of involvement. It has been demonstrated that there is no precise correlation between clinical symptoms and the histopathological status of the pulp, mainly in case of irreversible pulpitis, that might lead to a wrong diagnosis. Vitality tests such as cold test or electric pulp tests reveal only whether the pulp is responsive to respective stimuli or not. According to new Wolters pulpal clinical classification, Moderate pulpitis exhibit symptoms of prolonged reaction to cold, which can last for minutes, possibly percussion sensitive and spontaneous dull pain which are correspond to irreversible pulpitis.
Complete/partial pulpotomy are suggested to be the choice of treatment for such cases. It has been suggested that infection is often the cause of inflammation, an inflamed pulp should be able to heal if the source of infection is eliminated as in other body organs. Removal of trigger (i.e. caries) followed by application of biocompatible material which makes a good seal in a sterile environment has potential to allow for recovery and healing of the inflamed pulp tissue which is thought to be beyond recovery. Based on this premise, DPC can be considered as minimally invasive approach for the management of teeth with inflamed pulps in place of the conventional approach of partial/complete pulpotomy in adults
Aim: To compare the outcome of direct pulp capping and complete pulpotomy in mature mandibular permanent molars with clinical signs indicative of moderate pulpitis.
Objectives:
- To evaluate the clinical and radiographic success of direct pulp capping in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate the clinical and radiographic success of complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis.
- To evaluate pain incidence and severity after direct pulp capping and complete pulpotomy in mature permanent molars with clinical signs indicative of moderate pulpitis
P (Population) - Mature Permanent Mandibular molars with clinical signs of moderate pulpitis I (Intervention) -Direct pulp capping C (Comparison) - Complete pulpotomy O (Outcome) - Assessment of clinical and radiographic success at 12 months follow up.
- To assess incidence and reduction in pain post operatively at every 24 hours till 1 week
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct pulp capping | Experimental | Procedure: Direct pulp capping |
| Complete pulpotomy | Active comparator | Procedure: Complete Pulpotomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. The patient should be ≥18 years of age. 2. Restorable mature permanent 1 st and 2nd Mandibular molars with extremely deep caries (≥2/3 dentine involvement) 3. Tooth should give positive response to pulp sensibility testing. 4. Clinical diagnosis of moderate pulpitis. 5. Radiographic finding of periapical index (PAI) score ≤2. 6. Healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit).
- -
Key exclusion criteria (7 listed)
- Teeth with immature roots.
- No pulp exposure after caries excavation.
- Bleeding could not be controlled in 6 minutes.
- Signs of pulpal necrosis, sinus tract, swelling, insufficient bleeding after pulp exposure.
- History of analgesic intake in previous 1 week, or antibiotic intake in 1 month.
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 |
|---|---|---|
| Direct pulp cappingafter caries excavation, the pulp will be inspected visually. If bleeding present, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Cases in which bleeding will not stop within 6 minutes will be excluded from the study and further managed by RCT. The exposed pulp will be capped with MTA which will be freshly mixed according to manufacturer's instructions and placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier following which the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. Then tooth will be restored using composite resin following etch and rinse technique. | Procedure or surgery | Direct pulp capping |
| Complete Pulpotomyexposed pulp tissue will be amputated using fresh sterile large round diamond bur in a high-speed hand-piece under water coolant 28to the level of canal orifices. The pulp wound will be irrigated with 3% NaOCl. For hemostasis, sterile cotton soaked in 3% NaOCl will be placed over the pulpal wound for 2 minutes, repeated for up to 6 min if required. Root canal therapy will be initiated in cases in which haemostasis is not achieved within 6 minutes. After hemostasis, ProRoot MTA will be placed in thickness of 2 to 3 mm over the pulp exposure site using an amalgam carrier. After placement, the cavity floor will be dabbed with moist sterile cotton pellet to ensure the setting of MTA, followed by application of a layer of light-cure RMGIC over MTA and light-curing for 20s. The tooth then will be restored using composite resin following etch and rinse technique. | Procedure or surgery | Complete pulpotomy |
Primary outcome
Clinical and radiographic success
Time frame: 12 months
Clinical success criteria No history of spontaneous pain or discomfort except for the initial days after treatment. No tenderness to palpation or percussion and the tooth is functional. Normal mobility and probing pocket depth. Soft tissues around tooth are normal with no swelling or sinus tract. Radiographic success criteria No pathosis evident on the radiograph such as root resorption, furcal pathosis or new periapical pathosis. Periapical Index score 1 or 2 according to Orstavic6 et al.
1 secondary outcome
Pain incidence and reduction
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
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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, MDS study director
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 Direct pulp capping and Complete Pulpotomy in people with Moderate Pulpitis, 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 2 inclusion and 7 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 7 Jun 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?
Contact Vinay Kumar, MDS (8901149107, 29vinaykr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic success (time frame: 12 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 7 Jun 2024.