BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars.

A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P < 0.05.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King Abdulaziz University

Criteria

Patient inclusion criteria:

• Patients with at least two matched bilateral deep carious primary molars indicated for pulpotomy.

• Patients within the age group of four to eight years.

• Healthy patients (both physically and mentally) without any known medical history of systemic conditions contraindicating pulp treatment.

• Cooperative patients who had behavioral ratings "positive" or "definitely positive" according to the Frankl behavior classification scale.

• Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomforts, risks, and benefits.

• No patients were excluded on the basis of gender, race, social or economic background.

Patients not satisfying any of the above-mentioned criteria were excluded from the study.

Teeth inclusion criteria:

Teeth were selected based upon the following clinical and radiographic criteria:

Clinically, the study included teeth with restorable crowns, teeth with pathologic carious or mechanical exposure of vital pulps and teeth with no clinical symptoms or evidence of pulp degeneration, such as spontaneous or nocturnal pain, pain on percussion, history of swelling, or sinus tracts and teeth with no tenderness to percussion, physiologic or pathologic mobility. Radiographically, the recruited teeth should have a normal radiographic appearance with healthy supporting tissues, no signs of internal resorption, or pathologic external root resorption and no periapical or inter-radicular pathosis, with at least two-thirds of the root remaining (not more than one-third of the root is physiologically resorbed).

Teeth exclusion criteria:

Teeth were excluded if (1) any of the above-mentioned clinical or radiographic inclusion criteria were not satisfied, (2) hemostasis could not be achieved within 5 minutes by direct contact with a wet cotton pellet, prior to material placement, or (3) the remaining radicular tissue was non-vital (with suppuration or purulence necrosis).