Status:
COMPLETED
BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars
Lead Sponsor:
King Abdulaziz University
Conditions:
Dental Caries
Pulpotomy
Eligibility:
All Genders
4-8 years
Phase:
PHASE4
Brief 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 molar...
Detailed Description
Methods This study was written according to the Consolidated Standards of Reporting Trials (CONSORT) statement. Study design A double-blinded, split-mouth, randomized, controlled clinical study was d...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03779698
Start Date
May 1 2014
End Date
September 1 2016
Last Update
December 19 2018
Active Locations (1)
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1
King Abdulaziz University, Faculty of Dentistry
Jeddah, Mecca Region, Saudi Arabia, 21589