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

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 (78%-97.7%).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 og 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, Ballal et al. (2022) evaluated the success DPC following pulp wound lavage with NaOCl and saline, and 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 (Lessa et al. 2010), does not dissolve organic tissue (Gonçalves et al. 2016) and has allergic potential (Pemberton 2016).

Calcium hypochlorite \[Ca(OCl)₂\] has been proposed as an alternative to NaOCl owing to its comparable antimicrobial efficacy(Dal Bello et al. 2019) , lower cytotoxicity(Coaguila- Llerena, Ochoa- Rodríguez, et al. 2024), minimal collagen damage, and preservation of dentin mechanical properties(Coaguila-Llerena et al,2022).

Coaguila- Llerena et al. 2022 demonstrated that 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.

Coaguila-Llerena et al (2025) reported that 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 (De Paula et al., 2019; Dutta \& Saunders, 2012).

It also provides antimicrobial effects when used as an intracanal medication for regenerative endodontics procedures, or when added to endodontic sealers (Alfadda et al., 2021; Silva et al., 2021).

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.

Blattes et al(2017) reported that Ca(OCl)2 showed favourable outcomes in terms of cell migration, viability, and inflammatory response .

Although evaluated as an irrigant in root canal treatment(Oliveira Leal et al ,2025), 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.

• Postoperative pain [Срок оценки: 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 [Срок оценки: Baseline and at 24 hours, Day1,Day 2, Day 3, Day 4, Day 5, Day 6 and Day 7 after the treatment]