BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars

NCT03779698 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: FacultyofDentistry
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study was to prospectively compare the clinical and radiographic success rates of BiodentineTM pulpotomies versus formocresol pulpotomies in children vital primary molars. A randomized, split-mouth study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group. Children were followed-up at 3, 6 and 12 months for clinical evaluation and at 6 and 12 months for radiographic evaluation. Data were collected, tabulated and analyzed using Fisher exact and McNemar tests. The level of significance was set at P \< 0.05.

Conditions

Dental Caries; Pulpotomy

Keywords

BiodentineTM; Formocresol; Primary molars; Pulpotomy

Outcome Measures

Primary Outcomes (5)

• Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment

  Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 3 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.

  After 3 months

• Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment

  Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.

  After 6 months

• Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment

  Clinical evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using the preset clinical criteria. The pulpotomy procedure was decided a clinical success if the tooth fulfilled the following criteria: (1) No pain, (2) No swelling, (3) No tenderness to percussion, (4) No abscess or fistula, and (5) No abnormal tooth mobility.

  After12 months

• Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment

  Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 6 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.

  After 6 months

• Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment

  Radiographic evaluation of BiodentineTM and formocresol pulpotomies was performed 12 months after treatment using periapical radiographs. The pulpotomized tooth was judged to be radiographically successful if it demonstrated the following criteria: (1) Normal periodontal ligament space (2) No periapical and furcation pathosis, and (3) No internal resorption. If pulp canal obliteration (PCO) happened, it was recorded but not considered as a treatment failure.

  After 12 months

Study Arms (2)

BiodentineTM pulpotomy group

EXPERIMENTAL

A Bioactive Dentine Substitute (BiodentineTM, Septodont Ltd., Saint Maur des Faussés, France) was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface.

Other: BiodentineTM; Drug: Formocresol

Formocresol pulpotomy group

ACTIVE COMPARATOR

A sterile cotton pellet moistened with 1:5 concentration formocresol (Buckley's Formocresol, Sultan Healthcare, Englewood, NJ, USA) then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing.

Other: BiodentineTM; Drug: Formocresol

Interventions

BiodentineTM OTHER

In the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.

Also known as: Bioactive dentine substitute

BiodentineTM pulpotomy group; Formocresol pulpotomy group

Formocresol DRUG

In control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.

Also known as: Buckley's Formocresol

BiodentineTM pulpotomy group; Formocresol pulpotomy group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with at least two matched bilateral deep carious primary molars indicated for pulpotomy.
• Patients within the age group of four to eight years.
• Healthy patients (both physically and mentally) without any known medical history of systemic conditions contraindicating pulp treatment.
• Cooperative patients who had behavioral ratings "positive" or "definitely positive" according to the Frankl behavior classification scale.
• Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomforts, risks, and benefits.
• No patients were excluded on the basis of gender, race, social or economic background.
• Patients not satisfying any of the above-mentioned criteria were excluded from the study.
• Teeth were selected based upon the following clinical and radiographic criteria: Clinically, the study included teeth with restorable crowns, teeth with pathologic carious or mechanical exposure of vital pulps and teeth with no clinical symptoms or evidence of pulp degeneration, such as spontaneous or nocturnal pain, pain on percussion, history of swelling, or sinus tracts and teeth with no tenderness to percussion, physiologic or pathologic mobility. Radiographically, the recruited teeth should have a normal radiographic appearance with healthy supporting tissues, no signs of internal resorption, or pathologic external root resorption and no periapical or inter-radicular pathosis, with at least two-thirds of the root remaining (not more than one-third of the root is physiologically resorbed).

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University, Faculty of Dentistry

Jeddah, Mecca Region, 21589, Saudi Arabia

Location

Related Publications (7)

• Erdem AP, Guven Y, Balli B, Ilhan B, Sepet E, Ulukapi I, Aktoren O. Success rates of mineral trioxide aggregate, ferric sulfate, and formocresol pulpotomies: a 24-month study. Pediatr Dent. 2011 Mar-Apr;33(2):165-70.

  PMID: 21703067 BACKGROUND

• Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent. 2004 Jul-Aug;26(4):302-9.

  PMID: 15344622 BACKGROUND

• Farsi N, Alamoudi N, Balto K, Mushayt A. Success of mineral trioxide aggregate in pulpotomized primary molars. J Clin Pediatr Dent. 2005 Summer;29(4):307-11. doi: 10.17796/jcpd.29.4.n80t77w625118k73.

  PMID: 16161395 BACKGROUND

• Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2011;9(8):672-7. doi: 10.1016/j.ijsu.2011.09.004. Epub 2011 Oct 13. No abstract available.

  PMID: 22019563 BACKGROUND

• Sonmez D, Sari S, Cetinbas T. A Comparison of four pulpotomy techniques in primary molars: a long-term follow-up. J Endod. 2008 Aug;34(8):950-5. doi: 10.1016/j.joen.2008.05.009.

  PMID: 18634926 BACKGROUND

• Fuks AB, Bimstein E, Guelmann M, Klein H. Assessment of a 2 percent buffered glutaraldehyde solution in pulpotomized primary teeth of schoolchildren. ASDC J Dent Child. 1990 Sep-Oct;57(5):371-5.

  PMID: 2120303 BACKGROUND

• El Meligy OAES, Alamoudi NM, Allazzam SM, El-Housseiny AAM. BiodentineTM versus formocresol pulpotomy technique in primary molars: a 12-month randomized controlled clinical trial. BMC Oral Health. 2019 Jan 7;19(1):3. doi: 10.1186/s12903-018-0702-4.

  PMID: 30612569 DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

formocresol

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Najlaa M Alamoudi, BDS,MSc,DSc

  King Abdulaziz University, Faculty of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatric Dentistry Department, Medical Director, KAU-DH Program Director, Post Grad Studies for Master and PhD programs Program Director,of Saudi Commission for Health Specialities, Faculty of Dentistry- King Abdulaziz University

Model Details: A double-blinded, split-mouth, randomized, controlled clinical study design was used with a sample of 37 healthy children aged 4- to 8-year-old. A total of 56 pairs (112 teeth) of carious primary teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the BiodentineTM pulpotomy group or the formocresol pulpotomy group.

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 19, 2018
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: September 1, 2016
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

SA (1)