Is Biodentine, as Successful as, Mineral Trioxide Aggregate

NCT ID: NCT03686475

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2017-09-30

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.

Conditions

Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Biodentine pulpotomy

Biodentine (Septodont, France) Pulpotomy for primary molars Clinical and radiographic evaluation Follow up at 1,3,6 and 12 months

Group Type: EXPERIMENTAL

Biodentine

Intervention Type: OTHER

pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month

MTA pulpotomy

MTA (Angelus- Londrina, Brazil) Pulpotomy for primary molars . it is fine hydrophilic powder consisting of tricalcium silicate, tricalicum aluminate, tricalcium oxide, silicate oxide and bismuth oxide11.

It is currently being used in pulpotomy of primary molars with a high rate of success.

Clinical and radiographic evaluation. Follow up at 1,3,6 and 12 months

Group Type: ACTIVE_COMPARATOR

MTA pulpotomy

Intervention Type: OTHER

MTA pulpotomy

Interventions

Biodentine

pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month

Intervention Type: OTHER

MTA pulpotomy

MTA pulpotomy

Intervention Type: OTHER

Other Intervention Names

tricalcium silicate cements

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Randa Youssef Abd Al Gawad

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Randa Abd El Gawad

Role: STUDY_DIRECTOR

Cairo University

Other Identifiers

regenerative pulpotomoy

Identifier Type: -

Identifier Source: org_study_id