Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars

NCT02393326 | Withdrawn

• 1 other identifier: 0644-14-HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective: To compare success rates of biodentine partial pulpotomy versus formocresol pulpotomy treatment of pulpally exposed lower primary molars. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the biodentine partial pulpotomy (PP) or the formocresol pulpotomy (FP) group. The follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals.

Conditions

Pulpotomy; Tooth, Deciduous

Outcome Measures

Primary Outcomes (2)

• partial pulpotomy clinical success rate

  Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure.

  6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months

• partial pulpotomy radiographic success rate

  For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.

  6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months

Secondary Outcomes (2)

• Formocresol pulpotomy clinical success rate

  6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months

• Formocresol pulpotomy radiographic success rate

  6-month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months

Study Arms (2)

Partial pulpotomy with biodentine

EXPERIMENTAL

Biodentine is gently applied to the pulp stumps

Procedure: partial pulpotomy with biodentine

Formocresol pulpotomy

OTHER

A cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min.

Procedure: Formocresol pulpotomy

Interventions

partial pulpotomy with biodentine PROCEDURE

After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol

Partial pulpotomy with biodentine

Formocresol pulpotomy PROCEDURE

Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM.

Formocresol pulpotomy

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The clinical criteria: primary molar with a deep carious lesion
• Sufficient tooth structure for restoration with a stainless steel crown
• No history of spontaneous pain
• Tenderness to percussion or abnormal mobility
• Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
• The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology
• Obliteration of the pulp and root canal, or internal or external root resorption.
• Physiologic root resorption, while included in the criteria, could not be more than one-third of the root length.

You may not qualify if:

• The clinical criteria: history of spontaneous pain
• Tenderness to percussion or abnormal mobility
• Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated.
• The radiographic criteria: tooth with furcation or radicular pathology
• Obliteration of the pulp and root canal, or internal or external root resorption.
• Physiologic root resorption more than one-third of the root length.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Interventions

tricalcium silicate

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: pediatric dentist

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 19, 2015
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 14, 2018

Record last verified: 2018-03