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Clinical and Radiographic Evaluation of Biodentine Versus Formocresol

Primary Purpose

Pulp Disease, Dental

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biodentine
Formocresol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Disease, Dental

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Adel Elbardissy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biodentine

Formocresol

Arm Description

Regenerative material for pulp therapy

Fixative agent for pulp therapy

Outcomes

Primary Outcome Measures

Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire.
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

Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.
Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination).
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ) with assessment of change over time.
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) with assessment of change over time.
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) with assessment of change over time.

Full Information

First Posted
June 3, 2018
Last Updated
June 27, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03582319
Brief Title
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol
Official Title
Clinical and Radiographic Evaluation of Biodentine Versus Formocresol in Vital Pulpotomy of Primary Molars: (A Randomized Control Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 12, 2017 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial, double blinded using split mouth technique.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Regenerative material for pulp therapy
Arm Title
Formocresol
Arm Type
Active Comparator
Arm Description
Fixative agent for pulp therapy
Intervention Type
Other
Intervention Name(s)
Biodentine
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Formocresol
Other Intervention Name(s)
Tricresol formalin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessing survival rate regarding absence of spontaneous pain over time. using a questionnaire.
Description
measurement of survival rate regarding absence of spontaneous pain and assessing the change over time ( binary outcome measured by direct questioning to the patient.
Time Frame
3,6,9 and12 months.
Secondary Outcome Measure Information:
Title
Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.
Description
Absence of abscess, fistula or pathologic mobility ( binary outcome measured by visual and clinical examination).
Time Frame
3, 6, 9 and 12 months.
Title
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).
Description
Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ) with assessment of change over time.
Time Frame
6 and 12 months.
Title
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .
Description
Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) with assessment of change over time.
Time Frame
6 and 12 months
Title
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .
Description
Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) with assessment of change over time.
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Adel Elbardissy
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical and Radiographic Evaluation of Biodentine Versus Formocresol

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