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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06293521
Other study ID # 06091995
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date May 16, 2024
Est. completion date January 1, 2025

Study information

Verified date February 2024
Source Cairo University
Contact Nada Mostafa, B.D.S
Phone 01117311533
Email Nadamostafa@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits


Description:

Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date January 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility Inclusion Criteria: 1. Aged 4 to 6 years , in good general health 2. The parents provided written informed consent. 3. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue. 4. Restorable teeth. Exclusion Criteria: 1. With systemic disease. 2. Physical or mental disability. 3. Unable to attend follow-up visits. 4. Refusal of participation. 5. Previously accessed teeth. 6. Swelling, tenderness to percussion or palpation, or pathological mobility. 7. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Pulpotomy
After the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.
Partial Pulpectomy
Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol. The tooth with then be restored with stainless steel crown

Locations

Country Name City State
Egypt Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Radiographic assessment Absence of periapical radiolucency or absence of internal/ external root resorption Month 6 , Month 12
Secondary Clinical effectiveness absence of any complication or complementary treatment: Absence of spontaneous pain & Absence of swelling. Month 3,Month 6,Month 9,Month 12
Secondary Child cooperation Modified frankl scale ,Categorical rating (rating 1 is definitly negative
- Rating 5 is definitely positive )
Day 0
Secondary Time elapsed till final restoration performed Stopwatch , measured in minutes Day 0
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