Clinical and Radiographic Assessments of Potassium Nitrate in Polycarboxylate Versus Mineral Trioxide Aggregate as Pulpotomy Biomaterials in Immature Mandibular First Permanent Molars

NCT03166748 | Unknown

• 1 other identifier: CBC-CU-2017-0518
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this RCT is to compare the clinical/radiographic outcomes of Potassium nitrate in polycarboxylate cement and MTA as pulpotomy biomaterials used for asymptomatic vital immature permanent lower first molar and this will help to clinically evaluate the use of alternative capping material in vital pulpotomy in young permanent teeth with pathologic pulpal injuries emphasis is set on avoiding total pupectomy and maintaining radicular pulp vitality and function and therefore maintain the tooth in a viable condition that help root completion.

Conditions

Pulpotomy of Immature Lower First Molar(Apexegenesis)

Keywords

Incomplete lower first molar; Immature permanent molar; Potassium nitrate in polycarboxylate; Mineral trioxide aggregate .Mineral trioxid

Outcome Measures

Primary Outcomes (1)

• clinical signs and symptoms assessment

  patient will take a chart to make yes or no in this cases spontaneous pain, sensitivity to percussion ⁄ palpation excessive mobility soft tissue swelling sinus tract

  1 week, 3 month, 6 and 12 months after treatment

Secondary Outcomes (1)

• radiographic assessment of root completion

  post operative,3 month, 6 and 12 months after treatment)

Study Arms (2)

MTA pulpotomy

ACTIVE COMPARATOR

mineral trioxide aggregates (MTA) is accepted as an optimum material for use in vital pulp therapy of permanent teeth

Combination Product: Potassium Nitrate in Polycarboxylate cement

Potassium Nitrate in Polycarboxylate cement

EXPERIMENTAL

Potassium nitrate (KNO3) is a superior desensitizer for hypersensitive teeth. Used with polycarboxylate cement, it serves as an effective liner for deep carious lesions. Also when placed under deep restorations with less than 1 mm of protective dentin remaining, it was effective in preserving pulpal vitality and it diminished the incidence and severity of post-restoration pain. As temporary cement (Kno3/zinc oxide eugenol \[ZOE\]) It reduced pain following full crown preparation.

Combination Product: Potassium Nitrate in Polycarboxylate cement

Interventions

Potassium Nitrate in Polycarboxylate cement COMBINATION_PRODUCT

The application of polycarboxylate cement containing 5% KNO3 for direct capping of traumatically exposed pulp in animal models did not result in any degenerative changes in dental pulp, thought creating optimal conditions for preservation of pulp vitality and root completion. Polycarboxylate cement has very thin film thickness and bonds firmly to the tooth structure, is capable of withstanding the overlying pressure during restoration procedures. The good adhesive properties of polycarboxylate cement containing 5% KNO3 guaranteed the closure of cavity, good and lasting protection of traumatically exposed dental pulp and the formation of alkaline environment possessing a strong antiacidic, anti-inflammatory and antibacterial effect of this pulp capping material, creating optimal conditions for expression of its natural reparative potential. The increased release of potassium nitrate from polycarboxylate cement by time, might be the cause of decreasing the inflammatory intensity

MTA pulpotomy; Potassium Nitrate in Polycarboxylate cement

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Egyptian children from 6-9 years
• Pathological caries or traumatic exposure
• lower immature first molar
• Asymptomatic irreversible pulpitis (no clinical symptoms of tooth or periapical pain in case of deep dental caries with pulp exposure during caries excavation

You may not qualify if:

• Case of necrotic pulp tissue
• Pulp polyp
• Tooth tender to percussion
• Clinical progression into abscess formation.
• Medically compromised patient
• Tooth with abnormal anatomy
• Furcation involvement or canal calcification
• Excessive bleeding from root canal
• Tooth is unrestorable

Sponsors & Collaborators

• Cairo University: lead

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  BACKGROUND

MeSH Terms

Interventions

potassium nitrate; Polycarboxylate Cement

Intervention Hierarchy (Ancestors)

Polycarbonates; Polymers; Macromolecular Substances; Dental Cements; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Ghada El Hilaly eid, Professor of Endodontics

  operator

  STUDY CHAIR

Central Study Contacts

mohammed ibrahim ahmed, master degree candidate

CONTACT

+201006619722; mohammed-ahmed@dentistry.cu.edu.eg

. Hamdy Adly, Professor of Endodontics

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master candidate at endodontic department faculty of dentistry cu

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 25, 2017
• Study Start: June 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 25, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share