Bioactive Materials in Pulp Therapy of Primary Teeth

NCT04795830 | Completed Phase 4 DMC

• 1 other identifier: PED 20-5D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical and radiographic success of a new injectable, fast setting bioceramic root repair material (BC RRM) putty with mineral trioxide aggregate (MTA) in pulpotomy procedures of primary teeth. The null hypothesis (H0) is that there is no difference in the clinical and radiographic success between the TotalFill® BC RRM™ Fast Set Putty and Produits Dentaires™ (PD™) MTA WHITE when used as a pulp dressing in pulpotomies of primary molars.

Conditions

Pulpitis; Pulp Disease, Dental

Keywords

Pulpitis; Pulp Inflammation; Primary dentition; bioceramic; root repair material; deciduous dentition; pulpotomy; MTA; bioactive

Outcome Measures

Primary Outcomes (8)

• Clinical Success of Pulpotomy Treatment after 1 month follow up

  During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility

  1 month

• Clinical Success of Pulpotomy Treatment after 3 months follow up

  During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility

  3 months

• Clinical Success of Pulpotomy Treatment after 6 months follow up

  During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility

  6 months

• Clinical Success of Pulpotomy Treatment after 12 months follow up

  During the follow-up phase, clinical outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Clinical findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following clinical findings indicate the success of the material used in pulp therapy. Presence of any of the clinical findings will be considered as a failure of the material used in pulp therapy. Clinical findings: Pain on mastication or spontaneous pain, as reported by the patient, without clinical evidence of plaque retention around crown margins denoting poor oral hygiene Pain on percussion on clinical examination Non-physiologic mobility

  12 months

• Radiographic Success of Pulpotomy Treatment after 1 month follow up

  During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 1-month evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency

  1 month

• Radiographic Success of Pulpotomy Treatment after 3 months follow up

  During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 3-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency

  3 months

• Radiographic Success of Pulpotomy Treatment after 6 months follow up

  During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 6-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency

  6 months

• Radiographic Success of Pulpotomy Treatment after 12 months follow up

  During the follow-up phase, radiographic outcomes will be evaluated by the primary investigator and two other blinded calibrated examiners at the following timing: 12-months evaluation Radiographic findings will be discussed until all three examiners come to a conclusion of whether the pulp therapy of the tooth was a success or a failure. The absence of the following radiographic findings indicate the success of the material used in pulp therapy. Presence of any of the radiographic findings will be considered as a failure of the material used in pulp therapy. Radiographic findings: Pathological internal or external root resorption Interradicular or periapical bone loss Interradicular or periapical radiolucency

  12 months

Secondary Outcomes (3)

• Ease of handling of material

  during procedure

• Time to perform procedure

  during procedure

• Convenience of application

  during procedure

Study Arms (4)

Control group with Stainless Steel Crown (SSC)

ACTIVE COMPARATOR

After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of GC Corporation's EQUIA Forte High Translucency glass ionomer restorative (GC EQUIA Forte HT Fil Capsule) will be injected to fill the pulp chamber. Finally, the tooth will be restored with a stainless steel crown.

Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)

Control group with Restoration

ACTIVE COMPARATOR

After pulpotomy and hemostasis, MTA powder and liquid will be mixed according to the manufacturer's instructions and applied via MTA applicator to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth.

Combination Product: Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)

Study group with Restoration

EXPERIMENTAL

After pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber and restore the tooth.

Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molars

Study group with Stainless Steel Crown (SSC)

EXPERIMENTAL

After pulpotomy and hemostasis, BC RRM Fast setting putty will be applied from the manufacturer's syringe using a plastic instrument to cover the amputated pulp stumps. Using a glass ionomer gun, a capsule of glass ionomer restorative GC EQUIA Forte HT Fil Capsule will be injected to fill the pulp chamber. Finally, the tooth will be restored with a stainless steel crown.

Combination Product: Bioceramic root repair material as pulp dressing in pulpotomy in primary molars

Interventions

Bioceramic root repair material as pulp dressing in pulpotomy in primary molars COMBINATION_PRODUCT

BC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown.

Also known as: Bioceramic Root Repair Material Fast Set Putty (BC RRM-F), TotalFill® BC RRM™ Fast Set Putty, FKG Dentaire SA, Switzerland

Study group with Restoration; Study group with Stainless Steel Crown (SSC)

Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA) COMBINATION_PRODUCT

MTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars.

Also known as: PD™ MTA WHITE, Produits Dentaires SA, Switzerland

Control group with Restoration; Control group with Stainless Steel Crown (SSC)

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients who have a restorable vital deep carious primary molar which is indicated for pulpotomy
• Absence of clinical signs and symptoms; namely pain on percussion, tooth mobility, presence of sinus or fistula or history of swelling

You may not qualify if:

• Badly broken down, unrestorable teeth
• Teeth with previous pulp therapy treatment
• Presence of uncontrolled bleeding
• Clinical evidence of non-vitality; namely presence of an abscess or a sinus tract or premature mobility
• Radiographic evidence of bone resorption, internal or external root resorption, or periapical or interradicular radiolucency.
• Uncooperative patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Outpatient Clinic of the Department of Pediatric Dentistry, Ain Shams University

Cairo, 11566, Egypt

Location

Related Publications (1)

• Abdelwahab DH, Kabil NS, Badran AS, Darwish D, Abd El Geleel OM. One-year radiographic and clinical performance of bioactive materials in primary molar pulpotomy: A randomized controlled trial. J Dent. 2024 Apr;143:104864. doi: 10.1016/j.jdent.2024.104864. Epub 2024 Jan 26.

  PMID: 38281619 DERIVED

MeSH Terms

Conditions

Pulpitis; Dental Pulp Diseases

Interventions

Pulpotomy; mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Dina Abdelwahab, M.Sc.

  Department of Pediatric Dentistry and Dental Public Health, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to which group they are assigned to. Both materials used have the same white color and any labels on syringes will be hidden with appropriate wrap. Teeth treated will be assigned codes so that outcome evaluators at follow up appointments are blinded. Furthermore, baseline clinical and radiographic findings of sound teeth as well as after pulp therapy and stainless steel crown placement will not reveal the material being used at the intervention, since the stainless steel crown obscures the view clinically and radiographically. On the other hand, the operator/primary investigator cannot be blinded as she is already familiar with the nature of the materials used and their different modes of application. For statistical analysis, codes will also assure blinding and confidentiality.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry and Dental Public Health

Model Details: After informed consent, baseline clinical and radiographic assessment will be obtained and recorded in the patient's examination sheet. Enrolled participant's tooth will be then randomly allocated to the experiment or control intervention group. Participant will be recalled for follow up assessments at 1, 3, 6 and 12 months. A 14 day window, defined as 7 days before and 7 days after the due date, will be available to complete the 1 and 3 month follow-up evaluations and a 28 day window, defined as 7 days before and 21 days after the due date, will be available to complete the 6 and 12 month follow up evaluations.

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: March 12, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

EG (1)