Clinical and Radiographic Evaluation of Biodentine Versus Formocresol

NCT03582319 | Completed

• 1 other identifier: Abardissy
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (1)

• 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.

  3,6,9 and12 months.

Secondary Outcomes (4)

• Assessing absence of abscess, fistula or pathologic mobility over time using visual and clinical examination.

  3, 6, 9 and 12 months.

• Absence of periapical or inter-radicular radiolucency (binary outcome detected by periapical x-ray ).

  6 and 12 months.

• Absence of external or internal root resorption(binary outcome detected by periapical x-ray ) .

  6 and 12 months

• Absence of calcific metamorphosis in the radicular pulp canal (binary outcome detected by periapical x-ray ) .

  6 and 12 months

Study Arms (2)

Biodentine

EXPERIMENTAL

Regenerative material for pulp therapy

Other: Biodentine

Formocresol

ACTIVE COMPARATOR

Fixative agent for pulp therapy

Other: Formocresol

Interventions

Biodentine OTHER

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

Biodentine

Formocresol OTHER

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.

Also known as: Tricresol formalin

Formocresol

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Bleeding time after amputation of the coronal pulp tissue exceed normal limits (5 minutes).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Adel Elbardissy

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

tricalcium silicate; formocresol

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized clinical trial, double blinded using split mouth technique.

Study Record Dates

• First Submitted: June 3, 2018
• First Posted: July 11, 2018
• Study Start: February 12, 2017
• Primary Completion: January 20, 2018
• Study Completion: February 22, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)