Pulpotomy Medications in Primary Teeth

NCT05300152 | Completed

• 1 other identifier: 398/2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

this study is aimed to evaluate and compare the pulp response to ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth.

Conditions

Drug Effect

Outcome Measures

Primary Outcomes (1)

• the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth

  by assessment of reparative dentin formation in the histological sections of the tested teeth by detection of the presence of odontoblast cells (dentin forming- cells) and mineralized tissue between the capping material and the remaining pulp tissue.

  12 months

Secondary Outcomes (1)

• the reparative dentinogenesis process after application of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth

  12 months

Study Arms (2)

ACTIVA BioACTIVE Base/Liner

EXPERIMENTAL

is a BioACTIVE glass-incorporated light-curable pulp capping material also known as light-cured resin-modified calcium silicate

Procedure: pulpotomy procedure and Histological evaluation; Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody; Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody

Mineral trioxide aggregate (MTA)

ACTIVE COMPARATOR

is a bioactive materials containing calcium silicate

Procedure: pulpotomy procedure and Histological evaluation; Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody; Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody

Interventions

pulpotomy procedure and Histological evaluation PROCEDURE

Sixty primary teeth in thirty children aged 7-9 years selected from Outpatient dental clinic Pedodontic and Endodontic Departments, Suez Canal University. divided into group I includes 30 teeth treated with ACTIVA BioACTIVE Base/Liner and group II includes 30 teeth treated by MTA with standard pulpotomy procedure Patients will be recalled after 15 and 30-days . 15 teeth from group I and 15 teeth from group II will be extracted after 15 days then subjected to decalcification then15 teeth from group I and 15 teeth from group II will be extracted after 30 days \& subjected to decalcification procedure in 20% EDTA at 4 °C for approximately 5 weeks then embedded in paraffin. Serial sections will be cut at 5 µm thickness. Deparaffinize the sections by 2 changes of xylene for 10 minutes each. Stain in Harris hematoxylin solution for 8 minutes. mount with xylene based mounting medium for conventional histological assessment using light microscope

ACTIVA BioACTIVE Base/Liner; Mineral trioxide aggregate (MTA)

Immunohistochemistry Protocol for Fibronectin Antibody DIAGNOSTIC_TEST

1. Deparaffinization/Rehydration * Slides heated in an oven at 65C for 1 hour. * De-paraffinization 2. Antigen Retrieval * Immersion of slides into staining dish containing Antigen Retrieval Solution. * Placing the staining dish into rice cooker. * When turned to warm, unplug cooker * Allow to cool down for 20 min 3. Staining * Wash slides with TBST for 5 min on a shaker. * Inactivate endogenous peroxidase by 3% hydrogen peroxide for 10 min. * Block slides with blocking solution for 1 hour. * Dilute primary antibody in blocking buffer * Apply primary antibody to each section and incubate overnight in humidified chamber * Wash slides three times with TBST

ACTIVA BioACTIVE Base/Liner; Mineral trioxide aggregate (MTA)

Immunohistochemistry Protocol for Osteopontin Antibody DIAGNOSTIC_TEST

will be carried out via avidin-biotin-peroxidase complex method using a VECTASTAIN ABC Kit . Sections will be deparaffinized by xylene and graded ethanol then treated with 20 µg/ml Proteinase K for 10 min. to prevent endogenous peroxidase activity, sections is incubated for 30 min in 0.3% H2O2/methanol then treated with 0.1% blocking serum albumin and incubated with primary antibody for 30 min. Rabbit polyclonal anti-osteopontin and goat polyclonal anti-RANKL will be used. dilution of primary antibodies used will be osteopontin (1 : 6000-8000). After being washed with phosphate-buffered saline several times, sections will be incubated with biotinylated IgG for 30 min and subsequently with streptavidin-horseradish peroxidase for 30 min. Following several washes with phosphate-buffered saline, 3,3'-diaminobenzidine substrate will be applied. As a negative control, non-immune serum will be used instead of primary antibody.

ACTIVA BioACTIVE Base/Liner; Mineral trioxide aggregate (MTA)

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy \& cooperative child
• No history of spontaneous pain
• No pathologic tooth mobility
• Normal gingival and periodontal condition
• Absence of furcal/periapical radiolucency

You may not qualify if:

• Uncooperativeness of child and/or parents
• Unrestorable tooth
• history of spontaneous pain
• Percussion sensitivity

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

Related Publications (5)

• Holan G, Eidelman E, Fuks AB. Long-term evaluation of pulpotomy in primary molars using mineral trioxide aggregate or formocresol. Pediatr Dent. 2005 Mar-Apr;27(2):129-36.

  PMID: 15926290 BACKGROUND

• Gandolfi MG, Siboni F, Prati C. Chemical-physical properties of TheraCal, a novel light-curable MTA-like material for pulp capping. Int Endod J. 2012 Jun;45(6):571-9. doi: 10.1111/j.1365-2591.2012.02013.x. Epub 2012 Mar 31.

  PMID: 22469093 BACKGROUND

• Anthoney D, Zahid S, Khalid H, Khurshid Z, Shah AT, Chaudhry AA, Khan AS. Effectiveness of Thymoquinone and Fluoridated Bioactive Glass/Nano-Oxide Contained Dentifrices on Abrasion and Dentine Tubules Occlusion: An Ex Vivo Study. Eur J Dent. 2020 Feb;14(1):45-54. doi: 10.1055/s-0040-1703418. Epub 2020 Mar 13.

  PMID: 32168531 BACKGROUND

• Avram DC, Pulver F. Pulpotomy medicaments for vital primary teeth. Surveys to determine use and attitudes in pediatric dental practice and in dental schools throughout the world. ASDC J Dent Child. 1989 Nov-Dec;56(6):426-34.

  PMID: 2530256 BACKGROUND

• Omer SMM, Elsaied HAF, Alghonemy WY, El-Desouky SS. Histopathological and immunohistochemical characterization of pulp tissue reaction to ACTIVA BioACTIVE base/liner in primary teeth pulpotomy: a randomized clinical trial. BMC Oral Health. 2025 Jun 3;25(1):885. doi: 10.1186/s12903-025-06177-x.

  PMID: 40457274 DERIVED

Study Design

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

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 29, 2022
• Study Start: October 2, 2022
• Primary Completion: July 12, 2024
• Study Completion: August 5, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: for 1 month

Locations

EG (1)