Application of Different Biomaterials in the Preservation of Vital Pulp in Carious Deciduous Teeth

NCT03220360 | Unknown DMC

• 1 other identifier: ChengduMCHCH-001
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth.

Conditions

Tooth, Deciduous

Outcome Measures

Primary Outcomes (1)

• image findings

  To observe thickness of reparative dentin. Image data are processed by XCP technology, scanned and transferred to a computer for digital analysis, preoperative reference value is used as the basis.

  at month 12 after surgery

Secondary Outcomes (1)

• degree of root resorption

  at month 12 after surgery

Study Arms (3)

indirect pulp capping group

EXPERIMENTAL

Sixty children with deep caries of deciduous teeth underwent indirect pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

Procedure: indirect pulp capping

direct pulp capping group

EXPERIMENTAL

Sixty children with deep caries of deciduous teeth underwent direct pulp capping, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

Procedure: direct pulp capping

vital pulpotomy group

EXPERIMENTAL

Forty-five children with deep caries of deciduous teeth underwent vital pulpotomy, and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

Procedure: vital pulpotomy

Interventions

indirect pulp capping PROCEDURE

Sixty children with deep caries of deciduous teeth underwent indirect pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

indirect pulp capping group

direct pulp capping PROCEDURE

Sixty children with deep caries of deciduous teeth underwent direct pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

direct pulp capping group

vital pulpotomy PROCEDURE

Forty-five children with deep caries of deciduous teeth underwent vital pulpotomy and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.

vital pulpotomy group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Indirect pulp capping or direct pulp capping: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 4 and 7 years old; (3) The affected teeth present healthy periodontal occlusion or adjacent deep caries; (4) no history of spontaneous pain, root length more than 2/3, without periapical lesions and sinus; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
• Vital pulpotomy: (1) Patients from Chengdu Maternal and Child Center, China; (2) Age between 3 and 8 years old; (3) mandibular deciduous molars with deep caries; (4) all the affected teeth are in the stable phase of tooth root; (5) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.
• Blank control teeth: (1) The normal teeth on the opposite side of the teeth will be chosen as blank controls; (2) no dental caries; (3) X-ray films reveal that bifurcation and periapical area do not present shadow, and tooth root is also in stable period; (4) written informed consent is provided by parents or guardian after they indicate that they fully understand the treatment plan.

You may not qualify if:

• Patients with one or more of the following conditions will be excluded from this study.
• Dental pulp lesions, tooth resorption, pulp calcification, root tip or root furcation.

Sponsors & Collaborators

• Chengdu Maternal and Children's Health Care Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: June 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: July 18, 2017

Record last verified: 2017-07