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Clinical and Radiographic Evaluation of Biodentine Versus Formocresol

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ClinicalTrials.gov Identifier: NCT03582319
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Adel Abdel Azeem Elbardissy, Cairo University

Brief Summary:
Aim of the study: To compare Formocresol and Biodentine clinically and radiographically when used for pulpotomy of primary molars Study Design : A randomized control clinical trial (split mouth and double blind) was conducted on 43 (4-6 years-old) children with decayed vital mandibular primary molars which were treated by pulpotomy using both medicaments . All treated teeth were followed for one year (at 3, 6, 9 and 12 months clinically and at 6 and 9 radiographically).

Condition or disease Intervention/treatment Phase
Pulp Disease, Dental Other: Biodentine Other: Formocresol Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial, double blinded using split mouth technique.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
Actual Study Start Date : February 12, 2017
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : February 22, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biodentine
Regenerative material for pulp therapy
Other: Biodentine
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
Other: Formocresol
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 Name: Tricresol formalin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination. [ Time Frame: 3, 6, 9 and 12 months. ]
    Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination).

  2. 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.

  3. 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.

  4. Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) . [ Time Frame: 6 and 12 months ]
    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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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582319


Locations
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Egypt
Adel Elbardissy
Cairo, Egypt, 11311
Sponsors and Collaborators
Cairo University

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Responsible Party: Adel Abdel Azeem Elbardissy, Associate Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03582319     History of Changes
Other Study ID Numbers: Abardissy
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stomatognathic Diseases
Dental Pulp Diseases
Tooth Diseases