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Symptomatic Irreversible Pulpitis (SIP)NCT07748676

Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite

A study testing Partial pulpotomy using calcium hypochlorite as wound lavage agent and Partial pulpotomy using sodium hypochlorite as wound lavage agent in people with Symptomatic Irreversible Pulpitis (SIP) and Extremely Deep Caries, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).Primary objective is to evaluate and compare clinical and radiographic outcome of… Read more about this study

Who is it for?
Ages 18 to 40 years
What is being tested?
Partial pulpotomy using calcium hypochlorite as wound lavage agent and Partial pulpotomy using sodium hypochlorite as wound lavage agent
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteIndia
Study dates
29 Apr 2026to 28 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • patients aged 18-40 years
  • Mature permanent mandibular molars with extremely deep caries (caries penetrating the entire thickness of the dentine radiographically, without radiopaque zone separating lesion from the pulp) and clinical diagnosis of SIP with PAI score ≤ 2
  • Periodontally healthy teeth (probing pocket depth ≤3 mm and mobility within normal limit)
  • Patients having physical status of class 1 or 2 according to ASA classification
  • Pulpal bleeding could be controlled within 10 min following pulp amputation

Who cannot join

  • Non restorable teeth
  • No pulp exposure even after complete caries excavation
  • Necrotic or partially necrotic pulp upon exposure
  • Presence of sinus tract or soft tissue swelling
  • Radiographic signs of internal or external root resorption
  • Pregnant women

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dr. Mayank Arora, MDS contact

+918295964200

dr.arora002@gmail.com

Dr. Roshni N V, PG student contact

+919048217877

roshninv1997@gmail.com

India1 site, 1 recruiting
  • PGIDS

    Rohtak, Haryana, 124001

    Dr. Mayank Arora, MDS, +918295964200, dr.arora002@gmail.com

    Dr. Roshni N V, MDS, +919048217877, roshninv1997@gmail.com

    Recruiting

Other trials in India

About this study

The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).Primary objective is to evaluate and compare clinical and radiographic outcome of partial pulpotomy following use of 2.5% Ca(OCl)₂ and 2.5% NaOCl in mature permanent mandibular molars with symptomatic irreversible pulpitis.secondary objective is to evaluate OHRQoL and pain experience after use of 2.5% Ca(OCl)₂ and 2.5% NaOCl during partial pulpotomy in permanent mandibular molars with clinical signs indicative of symptomatic irreversible pulpitis.

Read the detailed description

The aim of this randomised control trial is to compare the effect of wound lavage using 2.5% Ca(OCl)₂ and 2.5% NaOCl on the outcome of partial pulpotomy in mature permanent mandibular molars with symptomatic irreversible pulpitis (SIP).

PICO P (Population) -Mature permanent mandibular molars with carious pulpal exposure and symptomatic irreversible pulpitis (SIP).

I (Intervention) - wound lavage using 2.5% Ca(OCl)₂ C (Comparison) - wound lavage using 2.5% NaOCl O (Outcome) -

  1. Assessment of clinical and radiographic success at 6 and 12 months of follow up.
  2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.

In symptomatic irreversible pulpitis (SIP), bacterial invasion of pulp tissue is common, however the inflammation is usually confined to the area adjacent to the carious lesion. It has been suggested that removal of this affected pulp tissue segment and the surrounding infected dentin can help create an environment that promote pulpal healing.

Mechanical removal of the infected pulpal tissue can be most conservatively done through partial pulpotomy (PP) where a superficial coronal inflamed pulp tissue (2-3 mm) is amputated.

PP has been proven useful in cases of irreversible pulpitis with a high success rate .This procedure is advantageous as it preserves the coronal pulp tissue and allows physiologic dentine deposition in the cervical area.

In contrast to complete pulpotomy (CP), PP removes only the superficial coronal pulp tissue, which may increase the likelihood of leaving behind affected pulp tissue.This part of the pulp, if left behind, may affect the outcome of PP. Hence, lavage with antibacterial agents in such cases may help in dissolving and disinfecting the superficial layer of the pulp wound.

Sodium hypochlorite (NaOCl) is widely used in VPT due to its antimicrobial activity, tissue-dissolving ability, and haemostatic properties. However, concerns regarding cytotoxicity, collagen degradation, compromised resin bond strength due to interference in polymerisation of composite, and handling hazards remain.

Other lavage agents such as normal saline and chlorhexidine (CHX) have shown limitations, Success of DPC following pulp wound lavage with NaOCl and saline observed significantly lower pulp survival with saline as compared to NaOCl.

CHX also exhibits dose and time- dependent cytotoxicity on fibroblastic and osteoblastic cell lines , does not dissolve organic tissue and has allergic potential .

Calcium hypochlorite [Ca(OCl)₂] has been proposed as an alternative to NaOCl owing to its comparable antimicrobial efficacy, lower cytotoxicity, minimal collagen damage, and preservation of dentin mechanical properties.

Ca(OCl)2 also releases calcium ions, suggesting a potential to promote mineralisation, this may be particularly relevant in teeth with pulp necrosis and incomplete root formation, in which REPs are indicated.

Ca(OCl)2 at 1.5% caused less structural damage to apical papilla ex vivo than NaOCl at the same concentration and had a more favourable influence on the viability, proliferation and osteogenic differentiation of human apical papilla cells(hAPCs) in vitro. Moreover, it did not impair cell chemotaxis. These findings suggest that Ca(OCl)2 may offer biological advantages in regenerative endodontic procedures.

As an endodontic irrigant, Ca(OCl)2 demonstrated organic tissue dissolution capacity .

It also provides antimicrobial effects when used as an intracanal medication for regenerative endodontics procedures, or when added to endodontic sealers .

In addition to its effective tissue dissolution capacity, calcium hypochlorite exhibits advantages such as a higher available chlorine content and a broader spectrum of microbial action.

Ca(OCl)2 showed favourable outcomes in terms of cell migration, viability, and inflammatory response .

Although evaluated as an irrigant in root canal treatment, its role as a pulpal wound lavage agent during pulpotomy has not been investigated.

This trial would help formulate evidence based clinical guidelines regarding use of calcium hypochlorite as wound lavage agent during pulpotomy.

Being tested
Partial pulpotomy using calcium hypochlorite as wound lavage agent, Partial pulpotomy using sodium hypochlorite as wound lavage agent
Keywords
partial pulpotomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partial pulpotomy using calcium hypochlorite as wound lavage agentProcedure or surgery

    Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% Ca(OCl)₂ group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study.

    The pulp wound was irrigated with 5 ml 2.5% Ca(OCl)₂ for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% Ca(OCl)₂ over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.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.

  • Partial pulpotomy using sodium hypochlorite as wound lavage agentProcedure or surgery

    Following pulp exposure and clinical assessment of pulp health through bleeding, the patient was randomly assigned to 2.5% NaOCl group.Patients who did not exhibit pulp exposure after complete caries removal, or those with partially necrotic pulp, were excluded from the study.

    The pulp wound was irrigated with 5 ml 2.5% NaOCl for 30 s. Haemostasis was achieved by placing the cotton pellets soaked with 2.5% NaOCl over the pulpal wound for 2 min. This process was repeated further if required, for a maximum of 10 min. Patients whose bleeding could not be arrested within 10 min had to undergo CP or pulpectomy. ProRoot MTA will be placed to a thickness of 2-3 mm gently over the pulpal tissue, a layer of RMGIC will be placed over the MTA.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 groups in NCT07748676
Study groupRoleWhat they receive
Partial pulpotomy using calcium hypochlorite as wound lavage agentExperimentalPartial pulpotomy will be performed using calcium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
Receives: Procedure: Partial pulpotomy using calcium hypochlorite as wound lavage agent
Partial pulpotomy using sodium hypochlorite as wound lavage agentActive comparatorPartial pulpotomy will be performed using sodium hypochlorite as wound lavage agent ,after establishing a clinical diagnosis of symptomatic irreversible pulpitis i.e. if the tooth showed symptoms triggered and lingered by cold stimuli.
Receives: Procedure: Partial pulpotomy using sodium hypochlorite as wound lavage agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 12 months

Secondary outcomes (2)
  1. 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

  2. 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.

  1. First posted6 Aug 2026
  2. Study start29 Apr 2026
  3. Primary completion28 Oct 2027 (estimated)
  4. Study completion28 Oct 2027 (estimated)

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748676
Sponsor's protocol ID
Roshni N V
Status last verified
Jul 2026
First submitted
31 Jul 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Partial pulpotomy using calcium hypochlorite as wound lavage agent and Partial pulpotomy using sodium hypochlorite as wound lavage agent in people with Symptomatic Irreversible Pulpitis (SIP) 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 5 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 26 Aug 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. Mayank Arora, MDS (+918295964200, dr.arora002@gmail.com), 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: 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 26 Aug 2026.

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