Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Clinical success rate
Study Overview
Brief Summary
A randomized clinical trial was carried out on 72 second primary molars indicated for pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) & the third received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless steel crowns. Subjects were monitored clinically and radiographically at one, three , six & 12 months.
Detailed Description
The study population included four to eight years old healthy and cooperative patients who presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with mandibular second primary molars indicated for pulpotomy which met specific inclusion and exclusion criteria. Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure.
Procedures:
Preoperative periapical radiograph using periapical film size two Speed D Film , was taken for the molars considered for treatment. Radiographs should be of proper film density and contrast for proper radiographic diagnosis.
The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and rubber dam isolation was performed, followed by caries removal and deroofing of the pulp chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton pellet applied for two to three min.
In Group 1:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 4 Years to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Absence of tenderness to percussion.
- •Absence of physiologic or pathologic tooth mobility.
- •No clinical evidence of pulpal inflammation or degeneration, such as history of swelling or presence of sinus tract.
- •Restorable teeth.
- •Absence of radiographic evidence of internal or external root resorption, pulpal calcification, or osseous disease (periapical or furcation infection
Exclusion Criteria
- •• Evidence of necrosis after access cavity preparation.
- •Hemostasis could not be achieved within three min after direct contact with a wet cotton pellet, prior to material placement.
Outcomes
Primary Outcomes
Clinical success rate
Time Frame: 12 Month
abscence of all clinical signs and symptoms of failure
Secondary Outcomes
- Radiographic success rate(12 Month)
Investigators
Randa Youssef Abd Al Gawad
Principal investigator
Cairo University