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

Pulp Disease, Dental Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04650113
• Other study ID #: CARopacpIPMUM
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 20, 2021
• Est. completion date: September 3, 2021

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: fatma abdelraouf, Msc
• Phone: 00201060771955
• Email: fatmaraouf.fr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1
• Est. completion date: September 3, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Pulp Disease, Dental
• Stomatognathic Diseases

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry cairo university	Al Manyal	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	analog scale	1 week
Primary	postoperative pain	analog scale	1 month
Primary	postoperative pain	analog scale	3 months
Primary	postoperative pain	analog scale	6 months
Primary	swelling	clinical examination	1 week
Primary	swelling	clinical examination	1 month
Primary	swelling	clinical examination	3 months
Primary	swelling	clinical examination	6 months
Primary	mobility	clinical examination	1 week
Primary	mobility	clinical examination	1 month
Primary	mobility	clinical examination	3 months
Primary	mobility	clinical examination	6 months
Secondary	root resorption	periapical radiograph	1 week
Secondary	root resorption	periapical radiograph	1 month
Secondary	root resorption	periapical radiograph	3 months
Secondary	root resorption	periapical radiograph	6 months
Secondary	Bone resorption	periapical radiograph	1 week
Secondary	Bone resorption	periapical radiograph	1 month
Secondary	Bone resorption	periapical radiograph	3 months
Secondary	Bone resorption	periapical radiograph	6 months