- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03582319
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study design Randomized clinical trial, double blinded using split mouth technique. Study setting This study was carried out in Pediatric Dentistry Department-Faculty of Dentistry-Cairo University- Egypt.
Patients
Patients recruited for this study were selected according to the following criteria:
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
- Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).
Sample size calculation using sealedenvelop.com, (30) the online sample calculator, sample size was calculated assuming the null hypothesis that biodentine and formocresol have an average success rate of 95,99 % and 87.8 % respectively (26, 31,32,33). Thus planning a binary outcome non inferiority trial with a difference of 8.19 %, then 76 primary molars (38 per group) are required to be 90% sure that the upper limit of a one-sided 95% confidence interval will exclude a difference in favor of the standard group of more than 10% (34).
With an estimation of 10% annual dropout, sample size was set to 86 primary molars (43 per group) (35). Forty three children with the matching criteria of patient selection were included in this study.
Research Ethics Committee approval was obtained from Faculty of Dentistry Cairo University. Detailed treatment plan and procedures were explained to the parents and informed written consent s were obtained before practical work.
Randomization Using 4 times folded papers in which one of the tested materials was written (43 paper for each material) contained in a closed white envelops (43 envelop in each one folded paper of each tested materials were placed), the selected two matched bilateral deep carious primary mandibular molars were randomly allocated to one of the tested materials.
When guardians agreed for their child to participate in the trial, an envelope was drowned and patient personal data was written on it. At the time of treatment of the first tooth in each patient, one of the folded papers was taken from the envelope and the type of the dressing material was recorded. Trial participant and outcome assessors were blinded to the type of materials used in each tooth.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt, 11311
- Adel Elbardissy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy children between 4 and 6 years of age with two matched bilateral deep carious primary mandibular first or second molars.
- No evident clinical symptoms of pulpal necrosis or pulp degeneration such as pain on percussion, spontaneous pain, history of swelling or presence of sinus tract.
- No pathologic or physiologic mobility.
- No radiographic evidence of internal and external resorption, pulp stone, and interradicular or periapical lesions (Preoperative radiograph).
- The remaining tooth structure would be restorable with a stainless steel crown.
- Bleeding time after amputation of the coronal pulp tissue was within normal limits (5 minutes).
Exclusion Criteria:
- Bleeding time after amputation of the coronal pulp tissue exceed normal limits (5 minutes).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biodentine
Regenerative material for pulp therapy
|
Biodentine is mainly composed of tricalcium silicate, calcium carbonate and zirconium oxides while the liquid contains calcium chloride as the setting accelerator and water reducing agent
|
Active Comparator: Formocresol
Fixative agent for pulp therapy
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Formocresol is a devitalizing and fixing agent which was introduced to dentistry since 1904 with full concentration of Buckley's formula (19% formaldehyde, 35 % cresol, and 15 % glycerin in distilled water).
A five times diluted formula of Buckley's formocresol was used in this study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire.
Time Frame: 3,6,9 and12 months.
|
measurement of survival rate regarding absence of spontaneous pain and assessing the change over time ( binary outcome measured by direct questioning to the patient.
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3,6,9 and12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.
Time Frame: 3, 6, 9 and 12 months.
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Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination).
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3, 6, 9 and 12 months.
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Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).
Time Frame: 6 and 12 months.
|
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ) with assessment of change over time.
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6 and 12 months.
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Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .
Time Frame: 6 and 12 months
|
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) with assessment of change over time.
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6 and 12 months
|
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .
Time Frame: 6 and 12 months
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Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) with assessment of change over time.
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6 and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Abardissy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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