Pulpotomy vital pulp therapy is a frequently performed therapeutic procedures in
pediatric dentistry. This procedure aims to preserve the vitality of primary teeth or
immature permanent teeth with pulp exposure due to caries and with no evidence of
radiographical pathology. Pulpotomies eliminate the bacterial infection from the tooth by
the partial removal of the apical pulp tissue, followed by the placement of a pulp
medicament and a base material on top of it. The most frequently used medicaments in
pulpotomy vital therapy are formocresol (FC), mineral trioxide aggregate (MTA), ferric
sulphate (FS), calcium hydroxide (CH), Bio-dentine (BD) and laser. Due to its high
success rate, FC is a commonly used medicament, and it is described as the 'gold
standard' for pulpotomy procedures. However, FC is a controversial medicament, because
ethe major component of formocresol; formaldehyde, has been classified by the
International Agency for Research on Cancer (IARC) as a possible human carcinogen.
Consequently, several studies were conducted to assess the toxic effects of using FC, and
the evidence suggested that, in the dental setting, there is very low exposure of
formaldehyde, and it should not exhibit any carcinogenic actions. Despite these findings
dentists in Europe still have some concerns regarding FC usage in vital pulp therapy, and
alternatively prefer other medicaments over FC, Such as Ferric Sulfate (FS); which is
their medicament of choice. FS is a hemostatic agent that is commonly used for
pulpotomies in primary teeth, this agent helps in retaining the vitality of the tooth by
forming a protective metal protein clot over the vital pulp tissue. Therefore, FS has
been widely studied over the world, and the evidence suggested that both FC and FS showed
comparable success rates clinically and radiographically as medicaments for pulpotomies
in primary molars. However, FC was anticipated to achieve a 10% higher success over FS in
a Trial Sequential Analysis (TSA) that was conducted at 24 months' time interval
comparing the radiographic success of FC and FS. These finding can be explained by the
fact that internal resorption in the most common cause of failure in FS pulpotomies in
primary molars. This has been attributed to the release of free eugenol from the zinc and
eugenol mixture of the base material over the pulp tissue. Zinc oxide-eugenol (ZOE) paste
is the most common base material placed over the infected pulp tissues during pulpotomies
of primary molars, however the evidence suggests that the eugenol component has been
associated with the failure of the vital pulp treatment in primary molars. Cavit (3M, US)
is another base material that contains Zinc-oxide, zinc sulphate, and calcium salts
without eugenol. This has been used a temporary restorative material with excellent
sealing capability. It has been shown that this material induces an alkaline potential
hydrogen (pH), which in terms plays an important role in hard tissue formation, by the
neutralization of the lactic acid formation from osteoclasts and the activation of the
alkaline phosphatases. The effectiveness of non-eugenol based Zinc oxide as a base
material over ferric sulphate treated pulp has not been explored. The hypothesis is that
the non-eugenol based ZOE could be used as an alternate to eugenol based ZOE and thereby
avoid the radiological failures. Therefore, this randomized controlled clinical
split-mouth trial aimed to evaluate and compare the effect of eugenol and non-eugenol
based ZOE on the success of primary tooth pulpotomies where FS is used as a medicament.
Null hypothesis: In primary molar pulpotomy, non-eugenol based ZOE placed over ferric
sulphate do not show higher success rate compared to eugenol based zinc oxide as a base
material
Alternate hypothesis: In primary molar pulpotomy, non-eugenol based ZOE placed over
ferric sulphate show a higher success rate compared to eugenol based zinc oxide as a base
material
