Evaluation of Different Materials in Pulpotomy of Primary Molars

NCT05981352 | Unknown

• 1 other identifier: Pulpotomy of Primary Molars
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the current study is to evaluate and compare clinical and radiographic success and antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (2)

• clinical pulp testing

  pulp testing clinically measured by zurn and seale criteria ,

  0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.

• Radio graphic pulp testing

  pulp testing radio graphic measured by digital radio graph parallel technique

  0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.

Study Arms (3)

Mineral trioxide aggregate (positive control group)

ACTIVE COMPARATOR

: according to the manufacturing instructions as following: * After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline. * Then Mineral trioxide aggregate will be placed directly on the pulp stumps.

Procedure: mineral trioxide aggregate pulpotomy

Dehydrated amniotic membrane group

EXPERIMENTAL

* After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute. * Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber.

Procedure: Dehydrated amniotic membrane pulpotomy

Hyaluronic acid group

EXPERIMENTAL

• After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .

Procedure: Hyaluronic acid pulpotomy

Interventions

mineral trioxide aggregate pulpotomy PROCEDURE

* After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline. * Then Mineral trioxide aggregate will be placed directly on the pulp stumps.

Mineral trioxide aggregate (positive control group)

Dehydrated amniotic membrane pulpotomy PROCEDURE

* After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute. * Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber.

Dehydrated amniotic membrane group

Hyaluronic acid pulpotomy PROCEDURE

* After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) . * The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol .

Hyaluronic acid group

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged from 4 to 8 years old.
• Patients who are free from ant medical condition.
• Patients who have a vital deep carious Mandibular primary molar which is indicated for pulpotomy .
• No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.
• No radiographic evidence of any periapical pathosis , Internal or external root resorption , Absence of discontinuity of lamina dura .
• Physiological root resorption not more than 1/3 of crown

You may not qualify if:

• Teeth that are badly broken down, that cannot be restored.
• Presence of uncontrolled bleeding after pulpotomy
• Patients/ parent guardians that refuse to sign informed consent.

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• eman Ib Abdel Maksoud, doctor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

eman Ib Abdel Masoud, doctor

CONTACT

01555682322; eman.abdelmaksoud@dent.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: August 8, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-05