Irreversible Pulpitis Clinical Trial
Official title:
MTA vs CEM Pulpotomy in Young Permanent Molars With a Diagnosis of Irreversible Pulpitis: A Randomized Clinical Trial
The aim of the study
The purpose of this present clinical study will be to assess :
" the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of
young permanent molar teeth with irreversible pulpitis .
" the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of
young permanent molar teeth with irreversible pulpitis.
Introduction and Review of Literature
Partial pulpotomy is generally regarded as the treatment of choice for immature teeth with
exposed. pulp tissue. This treatment preserves pulp function,thus allowing continued root
development . It was reported that 96% of teeth healed after being treated with partial
pulpotomies associated with complicated crown fractures. This technique consists of the
surgical amputation of 2-3mm of inflamed coronal pulp tissue. The wound surface is treated
with a capping agent to promote healing and maintain viability of the remaining pulp tissue.
It has been suggested that partial pulpotomy, compared with cervical pulpotomy, has many
advantages including preservation of the cell-rich coronal pulp tissue, a necessary element
for better healing , and the physiologic apposition of dentine in the coronal area. In
contrast, cervical pulpotomy removes all the coronal pulp tissue, leaving the crown without
the possibility of physiologic apposition of dentine, thereby increasing the risk of cervical
fracture. Vital pulp treatment with materials such as mineral trioxide aggregate (MTA) are
explored in studies on new trends in dental biomaterials .The successful use of MTA has been
reported for partial pulpotomy of caries-exposed immature permanent teeth 5 and permanent
teeth with irreversible pulpitits. On the other hand MTA possess some disadvantages; the most
important one is its cost.
Calcium-enriched mixture (CEM, BioniqueDent, Tehran, Iran) cement has been introduced as a
new endodontic biomaterial .This water-based tooth-colored cement is a biocompatible mixture
cement that releases calcium and phosphate ions to form hydroxyapatite to induce the
formation of a dentinal bridge.The product is alkaline (pH > 10.5) and releases calcium
hydroxide during and after setting.The clinical use of CEM cement is similar to that of MTA.
As a result, the characteristics of this cement are compared with MTA in some studies,
showing a shorter setting and working time for CEM as well as a lower film thickness. CEM
cement also shows a superior antibacterial effect 12 and improved handling 10. Both have
similar sealing ability. The stated advantages of CEM cement and its potential effect on
healing of the remaining pulp and the induction of dentinal bridge formation have led
researchers to recommend use of the material in pulp treatment procedures in permanent teeth
such as indirect and direct pulp cap, pulpotomy 13-17 and root-end fillings 18.One of the
benefits of CEM cement is in the treatment of permanent teeth associated with irreversible
pulpitis. The results of some clinical studies suggest vital pulp therapy with CEM as an
alternative treatment to root canal therapy in such case with irreversible pulpitis.
To date, few studies have compared CEM cement and MTA as dressing materials for direct pulp
cap and pulpotomy in young permanent molar teeth. The purpose of this present clinical study
will be to assess the effect of CEM cement in the pulpotomy of young permanent molar teeth
with irreversible pulpitis.
The aim of the study
The purpose of this present clinical study will be to assess :
" the successful clinical outcome of CEM cement in comparison to MTA in the pulpotomy of
young permanent molar teeth with irreversible pulpitis .
" the successful radiographic outcome of CEM cement in comparison to MTA in the pulpotomy of
young permanent molar teeth with irreversible pulpitis.
Materials and methods This is a double-blind, randomized, and con- trolled clinical trial.
Forty children will be assigned randomly into two groups (20 children each) by block
randomization, and allocation concealment will be done with closed envelop method. The sample
size was obtained by using the G* power software statistical analysis according to previous
studies. The research protocol will be approved by the Human Ethics Review Committee of the
Faculty of Dentistry, Suez Canal University. For this 1-year clinical study, patients aged
6-14 years will be selected from the endodontic and pedodontic Clinics in the University. All
of the parents will be told about the study and signed the informed consent.
Inclusion Criteria: Clinical examination reveals extended carious lesion on the molar teeth
surface not extending toward the root. All of the patients report a history of pain typical
of irreversible pulpitis ie; the chief complaints are of spontaneous pain lasting from a few
seconds to several hours in the days before consultation. This radiating pain is exacerbated
by hot and cold fluids and require analgesia for pain relief. The pain does not abate
following tooth brushing or flossing. All of the parents are willing to join the study. All
teeth are believed to be vital and the vitality of all the subjected molar teeth was checked
by the operator during the pulpotomy procedure through visual inspection of pulpal
hemorrhage.
Exclusion Criteria: Patients with systemic disease or physical or mental disability,
extremely poor oral hygiene, periodontal problems, signs of abscess or fistula or
non-physiological tooth mobility and non-restorable teeth will be excluded from the study.
Teeth with external or internal root canal resorption, or root canal calcification in
pre-treatment radiographs will be also excluded. Teeth where hemostasis can not be achieved
will be excluded.
Pulpotomy Procedure: The treatment procedure will be performed after obtaining adequate local
anesthesia with 2% lidocaine and 1/80,000 epinephrine ,the surface of the tooth was rinsed
with normal saline and cleaned by swab wetted by a 0.2% chlorhexidine oral rinse . Pulpotomy
procedures will be then performed with rubber dam then will be followed by complete removal
of caries using fissure diamond burs and round stainless-steel burs. Pulpotomy will be
performed with a sterile round diamond bur on a high-speed headpiece with copious water to
remove all of the inflamed pulpal tissue. Following pulp amputation, the pulp chamber will be
irrigated using 5% sodium hypochlorite until homeostasis is obtained. Teeth where hemostasis
can not be achieved were excluded.
The CEM powder and liquid or MTA powder will be mixed according to the manufacturer's
instruction and a base of approximately 2 mm of CEM cement will be placed over the amputation
site. A wet cotton pellet will be used for adaption of the cement to the tooth walls. After 1
week the patient will be recalled for final restoration of the tooth with amalgam or a
stainless steel crown. Prior to tooth restoration, the operator checks that the patient has
no pain or clinical problems (ie; tenderness to percussion, swelling, fistula or mobility due
to disease). A recall program is arranged for all patients and all of the teeth are evaluated
clinically and radiographically.
Clinical Assessment: Clinical success is reviewed at 7 days and 3, 6 and 12 months after
treatment. The teeth are tested for tenderness to percussion, soft tissue redness, dental
swelling, abscess and fistula indicating any extension of inflammation toward the root
canals. The parents are supplied with a telephone number so that they can inform the dentist
of any problems.
Radiographic Assessment: No internal or external root resorption, no loss of lamina dura
integrity, no periodontal ligament widening, and no alveolar bone resorption in the
periapical region are considered indicative of successful treatment.
The clinical and radiographic assessments are all performed by the same two calibrated
dentists. Where there initial is disagreement, consensus evaluations are performed by the two
examiners.
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