Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 100
• Participant gender: Both

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.

• Phase: Phase 0
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hadassah Medical Organization
• Last Updated: 2015-03-18

Criteria

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.