Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars

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.

Study Overview

• Status: Withdrawn
• Conditions: Pulpotomy; Tooth, Deciduous
• Intervention / Treatment: Procedure: partial pulpotomy with biodentine; Procedure: Formocresol pulpotomy

Detailed Description

• Prospective
• Study population: 100 patients.
• Study group: This study sample comprises mandibular primary molars from boys and girls aged between 3 and 7 years. The children have no systemic diseases according to the medical history supplied by the parents or guardians. The mandibular primary molars in this study are selected according to the following clinical and radiographic criteria. The clinical criteria: the presence of 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.
• Clinical technique: All teeth will be treated under local anaesthesia with rubber dam isolation. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm using a water-cooled high-speed handpiece with a #330 high-speed bur. The wound surface is irrigated with sterile saline solution and dried with cotton pellets to avoid clot formation. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the PP or the FP treatment group. The child will not know which treatment is assigned to each tooth. For the PP group, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol (IRM_; Dentsply). For the FP group, coronal access is obtained using high-speed handpiece with a #330 high-speed bur with water spray to further expose the pulp chamber. 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. After PP or FP treatment, all teeth are restored with a stainless steel crown.
• Follow-up: the follow-up for clinical and radiographic evaluation will be carried out at 6-month intervals. 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. 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 both the clinical and radiographic evaluation does not indicate any signs of failure.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partial pulpotomy with biodentine; Biodentine is gently applied to the pulp stumps	Procedure: partial pulpotomy with biodentine; 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
Other: Formocresol pulpotomy; A cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min.	Procedure: Formocresol pulpotomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formocresol 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
Formocresol 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

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 14, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0644-14-HMO-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No