Pulpotomy Medications in Primary Teeth

Sponsor

Suez Canal University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05300152

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drug Effect	Procedure: pulpotomy procedure and Histological evaluation Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody	N/A

Detailed Description

Pulpotomy is an endodontic technique that involves amputating the coronal pulp and covering the residual root pulp with a clinically effective pulp medicament that is bactericidal, capable of forming a biological barrier and allows the physiological root resorption until primary tooth exfoliation. In primary dentition, pulpotomy therapy is divided into three types based on the treatment goals: devitalization (mummification), preservation, and regeneration. Formocresol is the benchmark for pulpotomy treatment in primary teeth. Buckley first used it to treat nonvital permanent teeth in 1904, and it later became a common pulpotomy medication for primary teeth primarily because of its superior clinical success and simplicity of use . However, toxicity, mutagenicity, and carcinogenicity issues posed by the possible systemic spreading of FC molecules via the root canals raised concerns on its use ; as a result, a more biocompatible, nontoxic medication was required.

Biocompatible and bioactive materials containing calcium silicate have become increasingly common in paediatric dentistry in recent years because of their properties, which include stimulation of pulp cell regeneration, re - routing of the inflammatory response, and improving the healing ability of the remaining vital pulp . Mineral trioxide aggregate (MTA) was developed and implemented as a root-end filling at Loma Linda University in California, USA, in 1993; its physical and chemical properties were identified by Torabinejad et al ., in 1995. MTA is a chemical compound composed of tricalcium silicate, dicalcium silicate, tricalcium aluminate, calcium sulphate dehydrate, gypsum, and bismuth oxide . It hydrates to form a colloidal gel with a pH of 12.5, equivalent to that of calcium hydroxide . Moreover, it takes 3 to 4 hours to set with a compressive strength of 70 Mpa after setting, which is comparable to Intermediate Restorative Material (IRM) . MTA is a biocompatible substance that seals better than amalgam or zinc oxide eugenol (ZOE) [30-32] also, it retains pulp vitality and induces repair as it comes into contact with dental pulp or peri-radicular tissues. MTA has been thoroughly examined clinically and radiologically, as well as compared to other pulpotomy medicaments, and it has been reported that MTA should be considered the new gold standard for pulp-capping therapy. On the other hand, MTA has some drawbacks, including difficulty in manipulation, a long setting duration, a high cost, poor mechanical properties, poor adhesion to dental tissue and tooth staining .

Several recent calcium silicate-based materials have been developed in order to alleviate MTA's drawbacks. ACTIVA BioACTIVE Base/Liner, a BioACTIVE glass-incorporated light-curable pulp capping material, was recently introduced in 2014 as a "light-cured resin-modified calcium silicate" (RMCS) claiming composite's resilience, aesthetics, and physical properties, as well as improved calcium, phosphate, and fluoride release when compared to glass ionomer . It comprised of a diurethane and methacrylate-based monomer with a modified polyacrylic acid and polybutadiene-modified diurethane dimethacrylate as well as BioACTIVE glass as a filler . ACTIVA has three setting reactions: it cures with low intensity light for 20 seconds per layer and has both glass-ionomer (acid-base reaction) and composite self-cure setting reactions. The bioactivity of ACTIVA BioACTIVE products is dependent on a process in which the material reacts to pH cycles and actively participates in the release and recharging of considerable amounts of calcium, phosphate, and fluoride . Theses mineral components are concerned with promoting the development of mineralized hard tissue also, they promote the creation of a connective apatite layer and the development of a seal at the material-tooth interface .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Comparative Evaluation of Pulpal Response to ACTIVA BioACTIVE Versus Mineral Trioxide Aggregate (MTA) as a Vital Pulpotomy Medications in Primary Teeth: An in Vivo Study

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACTIVA BioACTIVE Base/Liner 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 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 Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody Deparaffinization/Rehydration Slides heated in an oven at 65C for 1 hour. De-paraffinization 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 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 Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody 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.
Active Comparator: Mineral trioxide aggregate (MTA) is a bioactive materials containing calcium silicate	Procedure: pulpotomy procedure and Histological evaluation 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 Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody Deparaffinization/Rehydration Slides heated in an oven at 65C for 1 hour. De-paraffinization 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 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 Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody 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.

Arm

Intervention/Treatment

Experimental: ACTIVA BioACTIVE Base/Liner

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

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

Diagnostic Test: Immunohistochemistry Protocol for Fibronectin Antibody

Deparaffinization/Rehydration Slides heated in an oven at 65C for 1 hour. De-paraffinization 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 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

Diagnostic Test: Immunohistochemistry Protocol for Osteopontin Antibody

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.

Active Comparator: Mineral trioxide aggregate (MTA)

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

Outcome Measures

Primary Outcome Measures

the regenerative effect of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth [12 months]
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.

Secondary Outcome Measures

the reparative dentinogenesis process after application of ACTIVA BioACTIVE Base/Liner and MTA as pulpotomy medication in primary teeth [12 months]
by assessment the molecular signalling (production of fibronectin & osteopontin antibody) involved in cell differentiation during reparative dentinogenesis process using Immunohistochemistry

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Suez Canal University	Ismailia		Egypt

Sponsors and Collaborators

Suez Canal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

shaimaa shaban mohamed el-desouky, Lecturer of Pediatric dentistry, Suez Canal University

ClinicalTrials.gov Identifier:

NCT05300152

Other Study ID Numbers:

398/2021

First Posted:

Mar 29, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Antibodies

Immunoglobulins

Study Results

No Results Posted as of May 31, 2022