Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

NCT03838068 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 19118
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the vitality of traumatized immature anterior permanent teeth. Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analyzed.

Conditions

Pulp Exposure, Dental

Keywords

trauma; vital immature; MTA; Biodentine

Outcome Measures

Primary Outcomes (3)

• presence of pain,sensitivity to percussion/ palpation

  by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment

  18 months

• Swelling or sinus tract

  by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment

  18 months

• presence of mobility

  by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.

  18 months

Secondary Outcomes (2)

• Stage of root development

  18 months

• Presence of radiolucency

  18 months

Study Arms (2)

Mineral trioxide aggegate

ACTIVE COMPARATOR

white mineral trioxide aggregate (MTA) calcium silicate-based cement

Biological: mineral trioxide aggregate; Procedure: cervical pulpotomy; Drug: Local Anesthetics Procaine

Biodentine

EXPERIMENTAL

calcium silicate-based cement that consists of tricalcium silicate, dicalcium silicate, calcium carbonate, calcium oxide, zirconium oxide, and CH.

Biological: Biodentine; Procedure: cervical pulpotomy; Drug: Local Anesthetics Procaine

Interventions

Biodentine BIOLOGICAL

Biodentine is considered a calcium silicate cement

Also known as: Calcium silicate-based

Biodentine

mineral trioxide aggregate BIOLOGICAL

calcium based silicate cement

Also known as: MTA

Mineral trioxide aggegate

cervical pulpotomy PROCEDURE

coronal pulp tissue was removed till the orifice

Biodentine; Mineral trioxide aggegate

Local Anesthetics Procaine DRUG

40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance

Also known as: artinibsa

Biodentine; Mineral trioxide aggegate

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The patient age range 7.5-9 years.
• Noncontributory medical history
• Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm)
• The tooth should give positive response to cold testing
• Clinical diagnosis of reversible pulpitis without periapical rarefaction
• The tooth is restorable, mobility was within normal limits
• No signs of pulpal necrosis including sinus tract or swelling

You may not qualify if:

• Teeth with mature roots
• Signs and symptoms of irreversible pulpitis
• Non-restorable teeth
• Negative response to cold testing, the presence of sinus tract or swelling
• No pulp exposure
• Bleeding could not be controlled after full pulpotomy in 6 minutes

Sponsors & Collaborators

• Gihan M Abuelniel ,PhD: lead
• Cairo University: collaborator

Study Sites (1)

Gihan Abuelniel

Giza, 12566, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Exposure; Wounds and Injuries

Interventions

tricalcium silicate; mineral trioxide aggregate; Pemetrexed; Procaine

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gihan M Abuelniel

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients and their parents, the assessor and the statistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatric Dentistry

Model Details: Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 12, 2019
• Study Start: January 18, 2017
• Primary Completion: December 30, 2018
• Study Completion: August 15, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)