Long-term Evaluation of Direct Pulp Capping

NCT03403985 | Unknown

• 1 other identifier: JordanUST2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Calcium hydroxide and mineral trioxide aggregate have been used in vital pulp therapy with variable outcomes recorded by different study. They will be compared when used for direct pulp capping in cariously exposed mature permanent teeth.

Conditions

Dental Pulp Capping; Dental Caries Extending to Pulp

Outcome Measures

Primary Outcomes (1)

• clinical vital pulp therapy success

  Treatment was considered successful based on the absence of symptoms and signs Treatment was considered successful based on absence of symptoms and signs

  from date of randomization until failure reported for up to 100 months

Secondary Outcomes (1)

• Radiographic success

  from date of randomization until failure reported for up to 100 months

Study Arms (2)

calcium hydroxide direct pulp capping

EXPERIMENTAL

calcium hydroxide (Ca(OH)2 direct pulp capping will be performed in this group

Drug: Calcium Hydroxide (Ca(OH)2)

MTA direct pulp capping

EXPERIMENTAL

Mineral Trioxide Aggregate (MTA) direct pulp capping will be performed in this group

Drug: Mineral Trioxide Aggregate

Interventions

Calcium Hydroxide (Ca(OH)2) DRUG

Ca(OH)2 will be used in this group

Also known as: Ca(OH)2

calcium hydroxide direct pulp capping

Mineral Trioxide Aggregate DRUG

MTA will be used in this group

Also known as: MTA

MTA direct pulp capping

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• carious teeth that had no previous root canal treatment
• Pulpal diagnosis of normal or reversible pulpitis

You may not qualify if:

• History of irreversible pulpal pain
• Immature teeth
• Non restorable teeth
• Teeth with active periodontal disease
• History of any systemic disease
• Concurrent medication with systemic steroids, antibiotics, analgesics, immunomodulatory drugs or cytotoxics

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Dental health center

Irbid, Jordan

Location

MeSH Terms

Interventions

Calcium Hydroxide; mineral trioxide aggregate; Pemetrexed

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes; 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

Study Officials

• Lama Awawdeh, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients are not aware about type of capping material used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Retrospective clinical trial

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 19, 2018
• Study Start: June 1, 2017
• Primary Completion: June 28, 2017
• Study Completion: June 1, 2022
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

JO (1)