Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA

Clinical and Radiographic Assessment of Partial and Complete Pulpotomy in Primary Molars Using MTA : A Randomized Clinical Trial

that's comparison between partial and complete pulpotomy techniques in primary teeth

Study Overview

• Status: Unknown
• Conditions: Pulp Disease, Dental
• Intervention / Treatment: Combination product: MTA material

• Study Type: Interventional
• Enrollment (Anticipated): 1
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Al Manyal, Cairo, Egypt, 11562
      • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. - Medically free children who will be able and cooperative in all steps of the study.
2. - Asymptomatic primary molars with a deep carious lesion.
3. - Vital pulp due to dental caries with no clinical sign of pulpal degeneration (spontaneous pain, fistula, mobility) prior to treatment.

3 - Preliminary radiographs indicating absence of pathologic internal or external root resorption, or any evidence of inter-radicular bone destruction.

4 - Absence of pre-operative pain or they will only have a short-term pain. 5 - No tenderness to percussion. 6-Age ranging 4-6 years.

Exclusion Criteria:

1- Excessive bleeding during pulp amputation. 2 - Non vital teeth. 3 -History of spontaneous or prolonged pain. 4 - Swelling, tenderness, to percussion or palpation, or pathologic mobility. 5 - pre-operative radiographic pathology such as resorption (internal, external); periradicular or furcation radiolucency, or a widened periodontal ligament space.

6 - Parent or guardians who refuse participating in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ) 9.The pellet will be remove, and the pulp chamber filled with MTA. 10.The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement	Combination product: MTA material; Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.; Other Names: partial pulpotomy procedure
Active Comparator: group B; Pre-operative radiograph showing all roots and their apices.; Local anesthesia will be administered and a rubber dam will take place ,that ensure good isolation of the treated teeth.; Removal of caries; Pulp chambers will access using a no.330 bur in a high-speed hand piece with water coolant.; Removal of any remains of coronal pulp tissue with sharp sterile excavator or large bur in slow hand piece; Pulp amputation will perform using a spoon excavator.; Hemorrhage control will obtain within 5 minutes using sterile cotton pellets placed with light pressure over the pulpal stumps (if hemorrhage control will not be achieve, tooth will be exclude ); The pellet will be remove, and the pulp chamber will be filled with MTA.; The tooth will prepare and restore with a stainless steel crown cemented with glass ionomer cement. The periapical radiographic will be taken at this baseline visit .	Combination product: MTA material; Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.; Other Names: partial pulpotomy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain	analog scale	1 week
postoperative pain	analog scale	1 month
postoperative pain	analog scale	3 months
postoperative pain	analog scale	6 months
swelling	clinical examination	1 week
swelling	clinical examination	1 month
swelling	clinical examination	3 months
swelling	clinical examination	6 months
mobility	clinical examination	1 week
mobility	clinical examination	1 month
mobility	clinical examination	3 months
mobility	clinical examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
root resorption	periapical radiograph	1 week
root resorption	periapical radiograph	1 month
root resorption	periapical radiograph	3 months
root resorption	periapical radiograph	6 months
Bone resorption	periapical radiograph	1 week
Bone resorption	periapical radiograph	1 month
Bone resorption	periapical radiograph	3 months
Bone resorption	periapical radiograph	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: adel El-bardissy, prof, Associate Professor of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university; Study Director: rasha ragab, phd, Lecturer of Pediatric Dentistry and Dental Public Health, Faculty of Dentistry cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): January 20, 2021
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): September 3, 2021

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 24, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Tooth Diseases; Dental Pulp Diseases; Stomatognathic Diseases
• Other Study ID Numbers: CARopacpIPMUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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