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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04650113

Collaborator

(none)

Enrollment

Location

Arms

7.4

Anticipated Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental	Combination Product: MTA material	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

All participants will be randomly assigned to know which one of the right or left side will be allocated randomly in either the control or the intervention group. Sequence Generation Eligible consented participants will be randomly assigned to know which one of the participants will be control or intervention group according to a sequence generated on a Microsoft Excel sheet where the intervention (I) and the control (C) are simply randomized. The table of sequence generation will be kept with the co-supervisor.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 20, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Sep 3, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

postoperative pain [1 week]
analog scale
postoperative pain [1 month]
analog scale
postoperative pain [3 months]
analog scale
postoperative pain [6 months]
analog scale
swelling [1 week]
clinical examination
swelling [1 month]
clinical examination
swelling [3 months]
clinical examination
swelling [6 months]
clinical examination
mobility [1 week]
clinical examination
mobility [1 month]
clinical examination
mobility [3 months]
clinical examination
mobility [6 months]
clinical examination

Secondary Outcome Measures

root resorption [1 week]
periapical radiograph
root resorption [1 month]
periapical radiograph
root resorption [3 months]
periapical radiograph
root resorption [6 months]
periapical radiograph
Bone resorption [1 week]
periapical radiograph
Bone resorption [1 month]
periapical radiograph
Bone resorption [3 months]
periapical radiograph
Bone resorption [6 months]
periapical radiograph

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 7 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

- Medically free children who will be able and cooperative in all steps of the study.
- Asymptomatic primary molars with a deep carious lesion.
- 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry cairo university	Al Manyal	Cairo	Egypt	11562

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

fatma zainalabdieen abdelraouf, Master degree student, Cairo University

ClinicalTrials.gov Identifier:

NCT04650113

Other Study ID Numbers:

CARopacpIPMUM

First Posted:

Dec 2, 2020

Last Update Posted:

Dec 2, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

Yes

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

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Dental Pulp Diseases

Stomatognathic Diseases

Study Results

No Results Posted as of Dec 2, 2020