Clinical trial NCT03833557: Success Rate of Three Capping Materials
Official title: Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Keywords: Formocresol
MTA
Nanohydroxyapatite
Pulpotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) \& the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six \& 12 months.

Detailed description: The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.

Procedures:

Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.

The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.

In Group 1:

Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.

In Group 2:

The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.

Group 3:

A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.

All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.

Clinical and radiographic evaluation:

All treated patients were followed up at one, three , six \& 12 months after the pulpotomy.

The pulpotomized teeth were judged as clinically successful if they met the following criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth mobility. Radiographic success was defined if there were normal periodontal ligament space, absence of furcation or periapical radiolucency, absence of internal or external root resorption

Statistical analysis:

Data were collected, revised for completeness and logical consistency, tabulated, and statistically analyzed.

Eligibility criteria: Inclusion Criteria:

* • Absence of tenderness to percussion.

  * Absence of physiologic or pathologic tooth mobility.
  * No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
  * Restorable teeth.
  * Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection

Exclusion Criteria:

* • Evidence of necrosis after access cavity preparation.

  * Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.

Primary outcomes:
measure: Clinical success rate
timeFrame: 12 Month
Secondary outcomes:
measure: Radiographic success rate
timeFrame: 12 Month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Randa Youssef
Study officials:
References:
citation: Abd Al Gawad RY, Hanafy RMH. Success rate of three capping materials used in pulpotomy of primary molars: A randomized clinical trial. Saudi Dent J. 2021 Nov;33(7):560-567. doi: 10.1016/j.sdentj.2020.08.007. Epub 2020 Aug 29.