Clinical trial NCT03686475: Is Biodentine, as Successful as, Mineral Trioxide Aggregate
Official title: Is Biodentine, as Successful as, Mineral Trioxide Aggregate for Pulpotomy of Primary Molars? A Split Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Pulpotomy, Primary molars, Biodentine, MTA.
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 21
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 split-mouth controlled clinical trial was carried out on 21 healthy, three to seven years old children, with 42 pairs (84 molars) of contralateral mandibular primary molars indicated for pulpotomy. One paired tooth in one side was designated to Biodentine (Group 1) and the other side for MTA (Group 2) as a pulp medicament. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three, six and 12 months.

Detailed description: Study design:

The present study was a split-mouth controlled clinical trial.

Sample size:

A sample size of 21 patients with 42 pairs of molars (84 molars) was determined using online sample size calculator (Sealed envelope.com).

Subjects:

The study population included three to seven years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University and had two matched bilateral deep carious mandibular primary molars indicated for pulpotomy, that met specific inclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.

The criteria for inclusion in this study were:

* No history of spontaneous pain
* 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).

On the other hand, teeth were excluded if:

* 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.

Matched molars in each pair were randomly designated using computer software (Random.org) to Group 1: which received Biodentine (Septodont, France), or Group 2: which received MTA (Angelus- Londrina, Brazil), as pulp medicament.

Procedures:

Preoperative periapical radiograph using periapical film size two (Speed D Film, Kodak, US) 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 normal saline. Pulp hemostasis was achieved using a sterile wet cotton pellet applied for two to three min.

In Group 1: Biodentine was used according to the manufacturer's instructions. A capsule was gently tapped on a hard surface (to diffuse powder); five drops of liquid from the single dose dispenser were poured into the capsule which was placed in a triturator for 30 sec. The mixture was then introduced into the pulp chamber using amalgam carrier until the entire pulp chamber was completely filled.

In Group 2: MTA was used according to the manufacturer's instructions; the powder was mixed with sterile water in a 3:1 powder/water ratio 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.

Molars of both groups were finally restored with stainless steel crowns (3M, ESPE, Unitek, US) 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 and 12 months after the pulpotomy for clinical and radiographic evaluation as recommended by the American Academy of Pediatric Dentistry . Independently, two examiners evaluated the teeth clinically and radiographically.

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. Widening of the periodontal ligament was not considered failure in absence of other concurrent pathologies.

Eligibility criteria: Inclusion Criteria:

* No history of spontaneous pain

  * 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: radiographic success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Dr Randa Abd El Gawad
role: STUDY_DIRECTOR
References: