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BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars

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ClinicalTrials.gov Identifier: NCT03779698
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Najlaa Alamoudi, King Abdulaziz University

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.


Condition or disease Intervention/treatment Phase
Dental Caries Pulpotomy Other: BiodentineTM Drug: Formocresol Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Two full-time pediatric dentistry faculty members (other than the operator) from KAU blindly evaluated all the teeth clinically and radiographically.
Primary Purpose: Treatment
Official Title: BiodentineTM Versus Formocresol Pulpotomy Technique in Primary Molars: A 12-Month Randomized Controlled Clinical Trial
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Formocresol

Arm Intervention/treatment
Experimental: BiodentineTM pulpotomy group
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
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.
Other Name: Bioactive dentine substitute

Drug: Formocresol
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.
Other Name: Buckley's Formocresol

Active Comparator: Formocresol pulpotomy group
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
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.
Other Name: Bioactive dentine substitute

Drug: Formocresol
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.
Other Name: Buckley's Formocresol




Primary Outcome Measures :
  1. Clinical evaluation of BiodentineTM and formocresol pulpotomies 3 months after treatment [ Time Frame: After 3 months ]
    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.

  2. Clinical evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment [ Time Frame: After 6 months ]
    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.

  3. Clinical evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment [ Time Frame: After12 months ]
    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.

  4. Radiographic evaluation of BiodentineTM and formocresol pulpotomies 6 months after treatment [ Time Frame: After 6 months ]
    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.

  5. Radiographic evaluation of BiodentineTM and formocresol pulpotomies 12 months after treatment [ Time Frame: After 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient inclusion criteria:

  • 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 inclusion criteria:

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).

Teeth exclusion criteria:

Teeth were excluded if (1) any of the above-mentioned clinical or radiographic inclusion criteria were not satisfied, (2) hemostasis could not be achieved within 5 minutes by direct contact with a wet cotton pellet, prior to material placement, or (3) the remaining radicular tissue was non-vital (with suppuration or purulence necrosis).


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): NCT03779698


Locations
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Saudi Arabia
King Abdulaziz University, Faculty of Dentistry
Jeddah, Makkah, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University
Investigators
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Principal Investigator: Najlaa M Alamoudi, BDS,MSc,DSc King Abdulaziz University, Faculty of Dentistry

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Najlaa Alamoudi, 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, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT03779698    
Other Study ID Numbers: FacultyofDentistry
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Najlaa Alamoudi, King Abdulaziz University:
BiodentineTM
Formocresol
Primary molars
Pulpotomy
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Zinc Oxide
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs