Reversible PulpitisNCT07578662
Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis
A study testing Direct pulp capping in proximal carious lesion and Direct pulp capping in occlusal carious lesion in people with Reversible Pulpitis and Extremely Deep Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The aim of the study is to assess the Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with sign of reversible pulpitis. objective- Primary objective- To evaluate and compare the clinical and radiographic outcome of Direct pulp capping in mandibular molars with occlusal and… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Reversible Pulpitis, Extremely Deep Caries
- What is being tested?
- Direct pulp capping in proximal carious lesion and Direct pulp capping in occlusal carious lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteIndia
- Study dates
- 29 Apr 2026to 28 Apr 2028
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mature permanent mandibular molars with extremely deep caries that penetrate the entire thickness of dentine as detected on radiograph with reversible pulpitis will be included.
- Participant with Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following the removal of the stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and the pain experienced is not spontaneous.
- The pulpal sensibility will be confirmed through positive response to electric and cold tests (Endo frost) and the presence of bleeding after caries excavation. 4.Pulpal and the periapical diagnosis will be established based on the diagnostic terminology approved by American Association of Endodontists (AAE, 2019).
- 5.Teeth with a negative response to palpation and percussion testing and radiographic finding of periapical index (PAI) score ≤2 and healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) will be included. 6.Teeth in which hemostasis achieved within 5 mins will be included.
- 7.Only pulp exposures with size 0.5-1 mm will be included
- -
Who cannot join
- Mechanical or pulp exposure due to trauma
- absence of exposure after excavation of caries
- failure to achieve hemostasis within 5 mins
- irreversible pulpitis and teeth having periapical lesions
- periodontal disease, resorptive defects, calcified canals, as assessed by radiographic examination will serve as criteria for exclusion.
- Also immunocompromised, Pregnant and subjects having systemic diseases will be excluded -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
PGIDS Rohtak, Rohtak, Haryana 124001
Rohtak, Haryana, 124001
Dr. Pankaj Sangwan, MDS, +919996112202, drps_1@yahoo.co.in
Dr. Aditi Diwan, PG Student, +918968227626, aditidiwan0@gmail.com
About this study
Official title: Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
The aim of the study is to assess the Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with sign of reversible pulpitis. objective- Primary objective- To evaluate and compare the clinical and radiographic outcome of Direct pulp capping in mandibular molars with occlusal and proximal carious lesions. Secondary objective- To evaluate and compare 1.OHRQoL after Direct pulp capping in occlusal and proximal lesion. 2. Postoperative pain, after Direct pulp capping in occlusal and proximal lesion Subjects of age group 15 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with proximal carious lesion 2)Permanent mature molars with occlusal carious lesion.
Read the detailed description
Title- Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with reversible pulpitis PICO P (Population) - Mature permanent mandibular molars with extremely deep caries and signs of reversible pulpitis.I (Intervention) - Direct Pulp Capping in Proximal carious lesion. C (Comparison) - Direct Pulp Capping in Occlusal carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up.
- Assessment of OHRQoL pain experience at baseline, postoperatively every 24 hours for 1 week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to AAE, DPC should be performed only in mechanically exposed pulp. According to the position statement of European society of endodontology, however, if the teeth is vital and there is no sign of irreversible pulpitis, but has an extremely deep carious lesion with unavoidable pulp exposure, DPC can be the treatment of choice.According to bogen et al, DPC shows excellent success rate of 97.96% with MTA as capping agent material. In 2013, Cho et al, evaluated the outcome of direct pulp capping in cariously exposed pulp and the prognostic factors affecting the outcome. They found age and site of exposure to have a significant effect on the outcome of DPC.Site of exposure has always been the controversial topic, some studies show it has significant effect, some shows non- significant effect on outcome of DPC. As compare to occlusal lesion, in proximal lesion complete caries removal, application of pulp capping material and sealing of the cavity is difficult. Also, isolation is the key problem in proximal area which is difficult to obtain. All these factors have been suggested to make the outcome of proximal exposure more unfavorable than occlusal exposure with respect to prognosis of pulp capping. According to Cho et al, site of exposure shows significant effect on DPC and there is better survival rate on occlusal site [OR = 1] as compared to axial site [OR =3.9(1.3-15.8)]. Various studies have statistically assessed the site of exposure as secondary demographic variable affecting the outcome of DPC, there is no study till now which has directly, systematically compared the influence of occlusal and proximal lesion on the direct pulp capping.
Thus, the aim of the present study is to assess the influence of the proximal lesion on the outcome of direct pulp capping based on clinical and radiographical findings.
- Conditions
- Reversible Pulpitis, Extremely Deep Caries
- Being tested
- Direct pulp capping in proximal carious lesion, Direct pulp capping in occlusal carious lesion
- Keywords
- direct pulp capping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct pulp capping in proximal carious lesionProcedure or surgery
After pulp exposure, pulp wound will be irrgated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer ofRMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
Direct pulp capping in occlusal carious lesionProcedure or surgery
After pulp exposure, pulp wound will be irrgated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up.
| Study group | Role | What they receive |
|---|---|---|
| Direct pulp capping in proximal carious lesion | Experimental | Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds. Receives: Procedure: Direct pulp capping in proximal carious lesion |
| Direct pulp capping in occlusal carious lesion | Active comparator | Direct pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds. Receives: Procedure: Direct pulp capping in occlusal carious lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at 12 months
: Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption. Tooth will be considered successful when all the above parameters are met.
Measured: 18 months
Secondary outcomes (2)
Postoperative pain
Post Operative 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 Score100 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: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
OHRQoL assessment
OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale: never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL
Measured: Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start29 Apr 2026
- Primary completion28 Oct 2027 (estimated)
- Study completion28 Apr 2028 (estimated)
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.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Pankaj Sangwan, MDS, Principal investigator, PGIDS, Rohtak, 124001
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578662
- Sponsor's protocol ID
- Aditi Diwan
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Proximal Caries on Outcome of Direct Pulp Capping in Permanent Mandibular Molars With Reversible Pulpitis: A Prospective Study
- ClinicalTrials.gov ID
- NCT07578662
- Acronym / sponsor ID
- Aditi Diwan
- Conditions
- Reversible Pulpitis, Extremely Deep Caries
- Keywords
- direct pulp capping
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 28 Oct 2027 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 11 May 2026 (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.
The aim of the study is to assess the Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with sign of reversible pulpitis. objective- Primary objective- To evaluate and compare the clinical and radiographic outcome of Direct pulp capping in mandibular molars with occlusal and proximal carious lesions. Secondary objective- To evaluate and compare 1.OHRQoL after Direct pulp capping in occlusal and proximal lesion. 2. Postoperative pain, after Direct pulp capping in occlusal and proximal lesion Subjects of age group 15 - 40 yrs will be included and divided into two groups 1) Permanent mature molars with proximal carious lesion 2)Permanent mature molars with occlusal carious lesion.
Detailed description
Title- Influence of proximal caries on outcome of direct pulp capping in permanent mandibular molars with reversible pulpitis PICO P (Population) - Mature permanent mandibular molars with extremely deep caries and signs of reversible pulpitis.I (Intervention) - Direct Pulp Capping in Proximal carious lesion. C (Comparison) - Direct Pulp Capping in Occlusal carious lesion. O (Outcome) - 1. Assessment of clinical success at 7 days, 6 months, 12 months and radiographic success at 6 and 12 months of follow up.
- Assessment of OHRQoL pain experience at baseline, postoperatively every 24 hours for 1 week. Direct pulp capping is considered as the most conservative procedure to treat mechanically or traumatically exposed pulp. In this procedure, biomaterial is directly applied on the exposed pulp. According to AAE, DPC should be performed only in mechanically exposed pulp. According to the position statement of European society of endodontology, however, if the teeth is vital and there is no sign of irreversible pulpitis, but has an extremely deep carious lesion with unavoidable pulp exposure, DPC can be the treatment of choice.According to bogen et al, DPC shows excellent success rate of 97.96% with MTA as capping agent material. In 2013, Cho et al, evaluated the outcome of direct pulp capping in cariously exposed pulp and the prognostic factors affecting the outcome. They found age and site of exposure to have a significant effect on the outcome of DPC.Site of exposure has always been the controversial topic, some studies show it has significant effect, some shows non- significant effect on outcome of DPC. As compare to occlusal lesion, in proximal lesion complete caries removal, application of pulp capping material and sealing of the cavity is difficult. Also, isolation is the key problem in proximal area which is difficult to obtain. All these factors have been suggested to make the outcome of proximal exposure more unfavorable than occlusal exposure with respect to prognosis of pulp capping. According to Cho et al, site of exposure shows significant effect on DPC and there is better survival rate on occlusal site [OR = 1] as compared to axial site [OR =3.9(1.3-15.8)]. Various studies have statistically assessed the site of exposure as secondary demographic variable affecting the outcome of DPC, there is no study till now which has directly, systematically compared the influence of occlusal and proximal lesion on the direct pulp capping.
Thus, the aim of the present study is to assess the influence of the proximal lesion on the outcome of direct pulp capping based on clinical and radiographical findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct pulp capping in proximal carious lesion | Experimental | Procedure: Direct pulp capping in proximal carious lesionDirect pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds. |
| Direct pulp capping in occlusal carious lesion | Active comparator | Procedure: Direct pulp capping in occlusal carious lesionDirect pulp capping will be performed after establishing a clinical diagnosis of reversible pulpitis i.e. if the tooth showed symptoms triggered by cold stimuli but relieved within couple of seconds. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Mature permanent mandibular molars with extremely deep caries that penetrate the entire thickness of dentine as detected on radiograph with reversible pulpitis will be included.
- Participant with Reversible pulpitis will be diagnosed clinically based on discomfort experienced by the participant when a stimulus such as cold or sweet is applied and goes away within a couple of seconds following the removal of the stimulus, with no significant radiographic changes in the periapical region of the suspect tooth and the pain experienced is not spontaneous.
- The pulpal sensibility will be confirmed through positive response to electric and cold tests (Endo frost) and the presence of bleeding after caries excavation. 4.Pulpal and the periapical diagnosis will be established based on the diagnostic terminology approved by American Association of Endodontists (AAE, 2019).
- 5.Teeth with a negative response to palpation and percussion testing and radiographic finding of periapical index (PAI) score ≤2 and healthy periodontium (probing pocket depth ≤3 mm and mobility within normal limit) will be included. 6.Teeth in which hemostasis achieved within 5 mins will be included.
- 7.Only pulp exposures with size 0.5-1 mm will be included
Key exclusion criteria (6 listed)
- Mechanical or pulp exposure due to trauma
- absence of exposure after excavation of caries
- failure to achieve hemostasis within 5 mins
- irreversible pulpitis and teeth having periapical lesions
- periodontal disease, resorptive defects, calcified canals, as assessed by radiographic examination will serve as criteria for exclusion.
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 capping in proximal carious lesionAfter pulp exposure, pulp wound will be irrgated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer ofRMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up. | Procedure or surgery | Direct pulp capping in proximal carious lesion |
| Direct pulp capping in occlusal carious lesionAfter pulp exposure, pulp wound will be irrgated with 3%NaOCl, and bleeding will be controlled by placing a cotton pellet soaked with 3%NaOCl over the pulpal wound for every 2 minutes till 6 mints. Hemostasis will be achieved with 3% NaOCl for upto 6 mins if required. The time used to control bleeding will be recorded for each tooth. Teeth with excessive uncontrollable bleeding even after 5 mins will be excluded from the study; however, definite treatment will be provided to the patient. Size of exposure will be measured to be between 0.5-1mm using CPITN probe and Mani ball bur - 45. After that, ProRoot MTA of 2-3 mm thickness will be applied over the lesion followed by the application of layer of RMGIC. Then the tooth will be permanently restored with composite resin. After restoration, a postoperative periapical radiograph will be taken using a digital imaging system for comparative evaluation after 6 months and 12 months follow up. | Procedure or surgery | Direct pulp capping in occlusal carious lesion |
Primary outcome
Success rate at 12 months
Time frame: 18 months
: Criteria for success:- Clinical: 1. Absence of signs and symptoms of spontaneous pain or pain on stimulus and discomfort except for the first few days after treatment. 2. No tenderness to palpation or percussion and the tooth is functional. 3. Normal mobility and probing pocket depth. 4. Absence of associated soft tissue swelling, sinus or fistula. Radiographic: - 1. Absence of any periapical or interradicular radiolucency. 2. Complete radiographic healing (PAI score 1 or 2 acc. to Ostravik et al). 3. Absence of internal and external root resorption. Tooth will be considered successful when all the above parameters are met.
2 secondary outcomes
Postoperative pain
Time frame: Baseline and at 24 hours, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
OHRQoL assessment
Time frame: Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment
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 10 Jun 2026.
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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.
Dr. Pankaj Sangwan, MDS principal investigator
PGIDS, Rohtak, 124001
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 in proximal carious lesion and Direct pulp capping in occlusal carious lesion in people with Reversible Pulpitis and Extremely Deep Caries, 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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?
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 Dr. Pankaj Sangwan, MDS (+919996112202, drps_1@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate at 12 months (time frame: 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 10 Jun 2026.